CHECKLIST OF DOCUMENTS

TO BE SUBMITTED BY THE PI WITH THE IEC PROFORMA (PG THESIS)

Study Title: A study to assess the physical activity of post operative cardiothoracic
patients at the time of discharge in selected tertiary care hospital, Bengaluru with a view
to develop cardiac rehabilitation module.
PI Name: SRIDEVI ROY

Sl.No. Documents Yes No

1 Covering letter 

2 Project proposal – IEC application form 

3 Patient Information Sheet in English 

4 Informed Consent Form / Assent Form in English 

5 PIS / Informed Consent Form/ Assent Form in regional languages 

6 Subject recruitment procedures: advertisement, notices, if any 

7 Case record form 

8 Patient / subject Questionnaire/s 

9 Documentation of CTRI registration 

10 Request for waiver of consent 

11 Request for exemption from IEC review 

12 Administrative sanction from the Head of the Institution in case 

of collaborative studies with other institutions
13 Permission from the Head of the Department / units in case the 
guide / co-guide from other department / units
14 CV’s of the PI / Co-PI / Co-investigators / Guide 

15 Soft copies of the above documents 

 AX3 V1/SOP 8A/ V1
IEC Reviewer’s Check List

ST. JOHN’S MEDICAL COLLEGE HOSPITAL, BANGALORE

Study Ref No: [To be filled by IEC Secretariat] :

Scientific Reviewer’s Check List
Principal Investigator Sridevi Roy
Title of the study A study to assess the physical activity of post operative
cardiothoracic patients at the time of discharge in selected tertiary
care hospital, Bengaluru with a view to develop cardiac
rehabilitation module.
Mark x/ √ Comments
1. Title of the Study
2. Study Team Details
3. a. Source of monetary or material support
b. Sponsor / Funding Agency
c. Proposal being submitted for funding- Details
4. Study details
5. Review of literature with justification and need
for the study
6. Aims and Objective(s)
7. Proposed Methodology
a. Subjects
b. Type of subjects
c. Vulnerable subjects
d. Sample size & Basis
e. Subject’s Age group
f. Actual methodology
g. Procedures & Investigations
h. Potential hazards to those listed above
i.(i –xxiv) Additional Information on study
j. Statistical Analysis
k. Duration of the study
l. Dissemination of data
8. a. Consultant / Investigator responsible for study
 b. Investigator’s Personal experience
c. Role of each Investigators
9. Consent Process (a - g)
10 Financial implications (i-vi
11 Conflict of Interest (a – e)
12 Confidentiality (i – viii)
13 Study Documents (i-iv)
14 Permissions (i-v)
15 Risk Assessment

Scientific Reviewer’s comments:

Approved :

Further Clarification required :

Name: Signatures:
 COVERING LETTER

From

Ms. Sridevi Roy

1st year M.Sc. in NPCC

St. John’s College of Nursing

Bangalore

Through

The Principal

St. John’s College of Nursing

To

The Member Secretary

The IEC Committee

SJMCH, Bangalore

Title of the project

“A study to assess the physical activity of post operative cardiothoracic patients at the
time of discharge in selected tertiary care hospital, Bengaluru with a view to develop
cardiac rehabilitation module.”

Respected sir/madam

I, Sridevi Roy, 1st Year NPCC M.Sc Nursing student from Department of Medical Surgical
Nursing would like to conduct the above mentioned study as a part of partial fulfillment of
M.Sc Nursing program. I request you to kindly grant ethical clearance for the conduct of this
study.
I wish to seek ethical clearance for my study. Kindly do the needful.

Yours faithfully,

Principal Investigator
Ms. Sridevi Roy

1st year NPCC M.Sc(N)

 AX1 V2/SOP 9D/ V2.0
Postgraduate (Medical, Paramedical & Nursing) Thesis Proposal Submission Form

Application forms have to be filled and completed in all respects by the study team prior to
submission. Incomplete applications will not be accepted.
IEC Study Ref. No. (to be assigned by IEC
Secretariate)
1. Title of the Study:
A study to assess the physical activity of post operative cardiothoracic patients at the time
of discharge in selected tertiary care hospital, Bengaluru with a view to develop cardiac
rehabilitation module.
2 Study Team Details (Add additional rows if required)
Study
Name & Qualification Designation,
Sl. Designation Phone No &
of Investigators Dept. & Signature
No (e.g. PI, Guide, E-mail ID
(starting with PI) Institution
Co-Guide etc)
1 Ms. Sridevi Roy PI M.Sc. in Nurse 9353040731
M.Sc. in NPCC student Practitioner in Srideviroy199
Critical Care 7@gmail.com
2 Mrs. Sugandhi D’ Guide Assistant 9663645738
Souza Professor, Reach2sugand
Medical
M.Sc. (N) hi@gmail.com
Surgical
Nursing
St John’s
College of
Nursing
3 Dr. Sreekar Co-Guide Professor, 9986037868
Balasundarum Head Of sreekar73@gm
MBBS, MCh, DNB Cardiothoracic
ail.com
Vascular
Surgery ,
Dept. Of
cardiothoracic
and vascular
surgery And
Critical Care
St John’s
Medical
College and
Hospital
3a. Source of monetary or material support (Tick as applicable)
  S = Self E = Extramural Funding (non- I = Intramural Funding (SJNAHS)
funded SJNAHS)
3b. Information on sponsor / Funding – Extra/Intramural to be provided if applicable.
Not applicable

3c. Is the Proposal being SUBMITTED FOR FUNDING? YES  NO

If YES, Name of the Agency & Details:

Not applicable

4 Study Details (Tick as applicable)

 Descriptive Genetic Others: Specify
 Cross sectional Social Science
Cohort Record Review
Case contol Registry based
Validational /Diagnostic Secondary data analysis
Community based Trial / intervention
Vaccine Trial
Clinical trial (Hospital/ clinic)

5. Outline of previous work in the field with relevant references: (Should be short, and
precise) For ALL studies, this section must contain the following:

 Introduction
Physical activity can optimize patient outcomes after cardiac surgery, but postoperative
patients' physical activity generally has been inadequate. These include complication and
readmission rates, re-operation rates, 30-day mortality and morbidity. Cardio thoracic patients
who had low levels of physical activity were more likely to experience major adverse events
such as reoperation, wound infection, stroke, or renal failure. This study shows the level of
physical activity after a cardiothoracic surgery at the time of discharge1.

The subspecialty of interventional cardiology began in 1977. Since then, the discipline of
interventional cardiology has matured rapidly, particularly with regards to ischemic heart
disease. As a result, more patients are undergoing percutaneous catheter interventional therapy
for ischemic heart disease and fewer patients are undergoing surgical myocardial
revascularization. Those patients referred for surgical revascularization are generally older and
have more complex problems. Furthermore, as the population ages more patients are referred
to surgery for valvular heart disease. The result of these changes is a population of surgical
patients older and sicker than previously treated. These patients require even more specialized
postoperative care and pose unique challenges in critical care management. The clinical
challenges are accompanied by the need to provide care in a cost-conscious manner and in an
atmosphere that is carefully scrutinized and benchmarked. Managing postoperative cardiac
patients is more challenging now than in the past and it is extremely important that those
physicians providing critical care for the postoperative cardiac surgical patient have a clear
knowledge of their unique problems. This chapter is designed to provide a basic understanding
of the physiologic derangements of this group of patients and to offer treatment strategies for
their successful care2.

Cardiothoracic surgery is the specialty involved with the treatment of diseases affecting organs
within the thorax (the chest), principally the heart, lungs, and esophagus. Cardiovascular
disorders are an important public health problem worldwide. They are also the leading cause of
mortality and morbidity in the industrialized world. The annual cardiovascular mortality rate
was reported as 0.8%. In the United States alone, over 14 million persons suffer from heart
disease. In addition, there is evidence of a quick increase in heart disease along the Asian
region. Physical activity can optimize patient outcomes after cardiac surgery, but postoperative
patient physical activity generally has been inadequate. These include complication and
readmission rates, re-operation rates, 30-day mortality and morbidity. Physical activity is an
important component for recovery after surgery, both to help reduce post-operative
complications, e.g., pneumonia and venous thromboembolism, and as a marker of functional
recovery. Gentle walking is the best way to start, even if it is just for two minutes. Doing it
every day until it feels easier, then increase the time, and later the speed 3.

 Review of literature consisting of previous studies done on the same area of work
stating potential risks and benefits and outcome measures

Literature related to physical activity level after cardiothoracic surgery.

A comparative study was done on 5th post operative day to see the effectiveness of in-hospital
physiotherapy on handgrip strength and physical activity levels after cardiothoracic surgery,
among 34 patients in Medical College Hospital of Zhejiang University January 2021. In this
study physical activity was assessed with the handgrip strength test and the timed up and go
test. The result of the study shows that handgrip strength on the 5th post-operative day was
significantly different between the 2 groups that is patients who received physiotherapy during
hospitalization showed increased levels of handgrip strength and physical activity on the 5th
day after cardiac valve surgery compared to the control group4.

A cross sectional descriptive study was conducted to assess the influence of patient frailty on
physical activity post-surgery and other short-term outcomes after cardiac surgery in Imperial
College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom 2021. Data
was collected among 80 patients, undergoing a variety of cardiac surgical procedures
(coronary revascularization, valve repair/replacement, or combination). The result shows that
patients who stayed in hospital longer were more likely to suffer early postoperative
complications (stroke, renal failure, reoperation, pacemaker) if they were frail compared to
non-frail patients5.

An observation study was done on Cpax scores of patients after POD 1, POD 3, POD 6 and on
discharge day in a view to assessment of physical functions in patients undergoing cardiac
surgery using critical care physical assessment tool in DVVPF’S College of Physiotherapy,
Ahmednagar, India 2020. Data was collected from 30 patients who underwent CABG and
Valvular replacement surgery where length of stay in CTVS ICU was of over 72 hours. As a
result of the study the physical function is significantly improved from post op day 1 to the
discharge day when assessed by the Critical Care Physical Assessment Tool.7

Literature related to Exercise-based cardiac rehabilitation which improves hemodynamic

responses after cardiothoracic surgery.

A comparative study was conducted in a view to see whether Exercise-based cardiac

rehabilitation improves hemodynamic responses after cardiothoracic surgery among 32
patients in Isfahan Cardiovascular Rehabilitation Research Center, Iran 2021. While the
rehabilitation group (n =17, mean age: 62 ± 12 years) completed the cardiac rehabilitation
program for two months, the reference group (n = 15, mean age: 58.5 ± 12.5 years) did not
have any supervised physical activity during this period. The study concluded that there is a
significant improvement was observed in the distance walked in the rehabilitation group
compared to the reference group. It also caused a significant development in hemodynamic
responses to exercise such as resting and maximum systolic and diastolic blood pressure,
resting and maximum heart rate, ejection fraction and rate pressure product. Cardiac
rehabilitation significantly improved functional capacity and some hemodynamic responses
post coronary artery bypass grafting6.

REFERENCES
1. Ghashghaei FE, Sadeghi M, Marandi SM, et al. Exercise-based cardiac rehabilitation
improves hemodynamic responses after coronary artery bypass graft surgery. ARYA
Atheroscler. 2012 Winter;7(4):151-6. PMID: 23205048; PMCID: PMC3413083.
2. Kehler DS, Stammers AN, Tangri N, et al. Systematic review of preoperative physical
activity and its impact on postcardiac surgical outcomes. BMJ Open. 2017 Aug
11;7(8):e015712. doi: 10.1136/bmjopen-2016-015712. PMID: 28801404; PMCID:
PMC5724229.
3. Taylor RS, Brown A, Ebrahim S, Jolliffe J, et al. Exercise-based rehabilitation for
patients with coronary heart disease: systematic review and meta-analysis of randomized
controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi:
10.1016/j.amjmed.2004.01.009. PMID: 15121495.
4. Chen J, Zhang T, Bao W, et al. The effect of in-hospital physiotherapy on handgrip
strength and physical activity levels after cardiac valve surgery: a randomized controlled
trial. Ann Palliat Med. 2021 Feb;10(2):2217-2223. doi: 10.21037/apm-20-2259. PMID:
33725776.
5. Dibben GO, Dalal HM, Taylor RS, et al. Cardiac rehabilitation and physical activity:
systematic review and meta-analysis. Heart. 2018 Sep;104(17):1394-1402. doi:
10.1136/heartjnl-2017-312832. Epub 2018 Apr 13. PMID: 29654095; PMCID:
PMC6109237.
6. Abdullahi YS, Salmasi MY, et al. The Use of Frailty Scoring to Predict Early Physical
Activity Levels After Cardiac Surgery. Ann Thorac Surg. 2021 Jan;111(1):36-43. doi:
10.1016/j.athoracsur.2020.06.029. Epub 2020 Aug 18. PMID: 32818541.
7. Miss Priya G Katke, Reshma R Kolase. Assessment of Physical Functions in Patients
undergoing Cardiac Surgeries using Chelsea Critical Care Function Tool. 2020 April04.
https://www.ijcrt.org/papers/IJCRT2004518.pdf
Justification / need for the study
Approximately 35,000 cardiac surgery procedures are carried out in the India each year.
Cardiac surgery is undergoing a period of transition. Patients referred for cardiac surgery are
increasingly older, often have multiple chronic conditions and require more complex surgery
than historical cohorts. In addition, potentially better diagnostic tests, less invasive treatments
and new devices are being introduced into clinical care at an accelerated rate. In order to adapt
to these changes and deliver the best quality personalized care to these patients, high-quality
research evidence is needed. It is only through this evidence that we will be able to direct the
right care to the right individual patient at the right time 7. Participation in the post operative
independent physical activities reduces post operative complication, such as venous
thromboembolism and pulmonary complications. This improves post operative physiological
functional capacity, wound healing, and autonomic tone. Physical activity is an important
component for recovery after surgery, both as a way to help reduce post-operative
complications, e.g. pneumonia and venous thromboembolism, and as a marker of functional
recovery.

Previously patients were given weeks of bed rest which decreased their functional mobility,
but recently it has been found out that low level of physical activity is highly beneficial to the
patients. Multiple studies show that the post operative complication increases and early
participation in the physical activities is the integral component of rapid recovery leading to
optimal surgical outcome. Coming over Intensive care unit acquired weakness
(ICUAW)syndrome is a must for patient to be discharge ready. Early mobilization is
considered gold standard care. The possible benefits of early mobilization include minimizing
muscle wasting, reducing orthostatic intolerance, maintaining bone health, improving lung
function by increasing functional residual capacity, maintaining joint range of movement and
increased psychological wellbeing. Early mobilization in this patient group starts with very
basic in bed activities.7 I want to conduct this study as because it will help all post operative
cardiothoracic patients to cope up well with physical functioning which improves
physiological functional capacity and reduces the length of stay in hospital. Reducing hospital
stay helps the patients to be more free from infection burden and gains self confidence. So,
there’s a strong need for this study to improve the recovery rate, come over from Intensive care
unit acquired weakness in the post operative cardiothoracic patients.

For Clinical Trials:

 Drug detail in brief including not applicable
 Information on the rationale for using the drug & safety profile not applicable
 Information from earlier Phase I-IV studies, if any not applicable

6. Aims and Objective(s) of the Study:

1. To assess the level of physical activity of post operative cardiothoracic patients.

2. To find out the association of the physical activity with selected baseline variables.
 7. Proposed Methodology: Answer under the following Heads:
(a) SUBJECTS
- State inclusion criteria
o Patients who are undergone post operative cardiothoracic surgery like CABG,
MVR, AVR, DVR, Lung Decortication and are ready for discharge.
o Patient above the age group of 18 years.
- State exclusion criteria
 Patients who are Bedridden.
 Patients condition included under extremity paralysis.
 Patients who are handicap.
 Patients with musculoskeletal dystrophy.
 Patient with orthopedic surgery before cardiothoracic surgery.
 Patients who are already knowledgeable enough or had previous cardiothoracic
surgery.

(b) TYPE OF SUBJECTS (Tick)

Males Females Both Volunteers Patients Vulnerable subjects
  

(c) Are Vulnerable subjects included?  Yes No

Please state YES or NO against EACH item
Pregnant women NO Terminally ill NO Special Groups NO
Children (below 18 years) NO Seriously ill NO Students YES
Elderly (60 years and above) Illiterate YES Staff / Faculty / others NO
YES
Fetuses NO Economically Backward Captives NO
YES
Prisoners NO Socially Backward YES Institutionalized NO
Destitute NO Mentally challenged NO Armed Forces NO
Service providers NO Handicapped NO
Others (Specify) NIL

(d) SAMPLE SIZE and the BASIS for the same:

(Kindly indicate the relevant statistical assumptions and way in which the sample size has been
obtained)
In a study to assess the physical activity among post operative cardiothoracic patients, the
mean and SD of CPAx score was found to be approximately 43 ± 5.9 (Ref: Whelan et al.). To
observe similar result with 95% confidence level and 5% relative precision the minimum
required sample size is 29.
 Single Mean - Estimating the population mean - Relative precision
Standard Deviation 5.9 5.9 5.92
Mean 43 43 43
Relative Precision (%) 5 4 3
Desired confidence level (1- alpha) % 95 95 95
Required sample size 29 45 81

(e)Trial Subject’s AGE GROUP: Age ranges from …18… to …80.. years.

(f) Detail the ACTUAL METHODOLOGY to be followed in the proposed study - please
be specific and brief, describe preferably in steps (example – obtaining necessary
permissions, define key terms in the study, define sampling frame, describe
recruitment/sampling method, describe training/ interventions/assessments/ procedures in
the study, side effects, describe data handling)

Data collection:
Data collection will be done by Principal Investigator after obtaining clearance from
Institutional Ethics Committee (IEC) and formal permission from Associate Director Hospital
and departmental HODs. A descriptive cross-sectional design will be adopted for this study.
Subjects who fulfill the inclusion criteria will be selected using purposive sampling technique.
The purpose of the study will be explained with subject information sheet to the subjects and
written consent will be taken. The baseline variables will be collected using interview method.
After which level of physical activity will be assessed by using Critical Care Physical
Assessment tool. Total time taken will be 25-30 minutes per person.
The Critical Care Physical Assessment Tool consist of 5 level and 10 component such as:
Respirator Function, cough, moving within the bed (e.g. rolling), Supine to sitting on the edge
of the bed, dynamic sitting (unsupported sitting), standing Balance, sit to stand (checking hip
reflex), transferring from bed to chair, stepping, grip strength. Stepping will be assessed by
asking patient to get up from bed and standing on their own feet. If patient is not able to stand
and becomes unstable it will be considered as level 0. If patient is able to stand and is stable
can move with any assistance or at least one person help, it will be considered as Level 3.
When the patient is independent without any held or support, it will be considered as Level 5.
Grip strength will be predicted by mean of age and gender on the strongest hand. If patient is
not able to hold or lift hand it will be considered as Level 0. If patient is able to hold hand and
power of muscle is around 60% it will be considered as Level 3. If patient is able to hold hand
and power of muscle is more than 80% it will be considered as Level 5.
This score looks solely at strength, and as patients may learn to be functional in the absence of
strength, its general ability and validity for measuring physical morbidity is questionable. More
importantly, it is time consuming and relies on a degree of co-operation and cognitive function.
This tool is also used for post operative cardiothoracic patients in St John’s Medical College
and Hospital.
(g) From the methodology described earlier, if the research subjects are to undergo any
PROCEDURES/INVESTIGATIONS during their participation in the study (like
collection of blood/urine/feces, venipuncture, X-rays, intubation, special diet, drugs
administered with dose, others) please specify the procedures. If any intervention is
planned as part of the study, please mention that:
 The participants would not be undergoing any investigation as part of this research.

(h) State any potential or known HAZARDS of the procedure listed in No 7 (vi) (the
clause above) or any other potential hazard the study may involve. How does the
investigator intend to overcome this?
 There are no hazards that the subjects have to undergo as part of this study.

(i) Does the study involve any of the following?

i. Use of fetal tissue / abortus? Yes  No

ii. Use of organs / body fluids? Yes  No
iii. Use of Placebos? Yes  No
iv. If YES to (iii), justify the use of the same. What precaution will be taken to ensure the
safety of the patient who is to be given placebo? Is any standard treatment withheld?
Explain in detail.
v. Use of Pre-existing /stored/ left over samples? Yes  No
vi. If Yes to (v) is consent available? Yes  No/NA
Proof attached (Tick)
vii. Collection for banking / future research? Yes  No
viii. If YES to (vii) for how long?
ix. If YES to (vii) has appropriate consent been taken for such YES  NO
storage and future tests?
x. Use of biohazardous / infectious specimens? Yes  No
xi. Proper disposal of all material? Yes  No
 xii. Will any sample collected from patients be sent to extramural Yes  No
institutions within India?
xiii. Will any sample collected from patients be sent abroad? Yes  No
xiv. If YES to (xii or xiii), justify with details of collaborators
xv. Has appropriate transport & submission permission obtained? Yes  No/NA
Proof attached /Will Submit as soon as available (Tick)
xvi. Will the study data be shared outside India? Yes  No
xvii. If YES to (xvi), justify with details of collaborators
xviii. Is the proposal being submitted for clearance from Health Yes  No/NA
Ministry’s Screening Committee (HMSC) for International
Collaboration?
xix. Any genetic studies planned? Yes  No
xx. If YES to (xix) has appropriate consent form attached Yes  No/NA

(j) State the STATISTICAL ANALYSIS proposed for the study data.
The overall plan for the data is as follows:
 Data will be organized in master sheet
 The data will be analyzed using descriptive and inferential statistics.
 Descriptive statistics –
Frequency, percentage will be used to describe demographic variables.
 Inferential statistics –
The chi-square test will be used to determine the association of physical activity with
selected baseline variables undergone cardiothoracic surgery.

(k) DURATION of the study:

a. The total duration of the study: 1 years.
b. Time taken for each subject (if it involves interviews, follow up period): The
estimated time for each subject will be around 25 – 30 minutes following the
Critical Care Physical Assessment tool.

(l) Intended dissemination of data:

(i) Peer reviewed Scientific journal Yes

Conference Presentation Yes
Internal Report Yes
Submission to regulatory authorities No
Access to raw data and right to publish freely by all investigators in study Yes, access
to raw data
 and right to
publish
freely by all
investigators.
List the potential authors for publication:
 SRIDEVI ROY– PRINCIPAL INVESTIGATOR
 SUGANDHI D’ SOUZA – GUIDE
 DR. SREEKAR BALASUNDARUM– CO-GUIDE

(ii) Will the study related findings be shared with the patients / subjects / treating
team?
 YES
If yes, Give details
The study findings may be shared with the subjects based on their request.

8.
a) Which consultant / investigator(s) are responsible for conducting the study?
Ms. Sridevi Roy is the principal investigator responsible for conducting the entire study
under the guidance of Mrs. Sugandhi D’ Souza and Dr. Sreekar.

b) What is the INVESTIGATOR’S PERSONAL EXPERIENCE with the proposed

study, patient management and the associated techniques involved? The experience of
the guide/mentor to be mentioned if the PI lacks the necessary experience.

The principal investigator is a M.Sc. in Nurse practitioner student in critical care. The
PI has some experience in research, as the PI has been a part of a research project in her
undergraduate. Mrs. Sugandhi D’ Souza is a faculty of nursing as well as nurse
administrator. She is a recognized PG guide under the RGUHS. She has 30years of
clinical experience with 10 years of teaching experience. Dr. Sreekar, the Co-guide is a
cardiothoracic surgeon and has teaching and research experience. He is the Professor,
Head Of Cardiothoracic Vascular Surgery, Dept. Of cardiothoracic and vascular
surgery and critical care. The Co – guide also has experience guiding both medical
students and post graduate students in CTVS. Dr. Sreekar has 26 years of working
experience and till date.
c) Indicate the role of each investigator involved in the study. Refer the list: Concept,
Design, Screening of patients, Selection and recruitment of study subjects, Informed
consent, Laboratory investigations, Laboratory report interpretation, Treatment
decision, Patient / subject care during study period, SAE evaluation and reporting,
Examination of patients on follow-up, Data collection and monitoring of data,
Interpretation of data, Statistical analysis & Interpretation, Maintaining patients file and
master file of project, Drafting final report, Submission of final report to funding
agency and IHEC, Publication, Any other, please specify.
 d) SN Investigator’s Name
1 Sridevi Roy (PI)
2 Mrs. Sugandhi
D’Souza (Guide)
3 Dr. Sreekar
Balasundarum (Co-
Guide)
Roles
Concept and Design
Selection and recruitment of study subjects
Informed consent
Data collection
Maintaining subjects file and master file of
project
Analysis and interpretation
Drafting final report
Publication
Concept and design
Monitoring of data
Analysis and interpretation
Drafting final report
Publication
Concept and design
Monitoring of data
Analysis and interpretation
Drafting final report
Publication

9. CONSENT PROCESS:

a. Consent (Tick)  Written Oral with Audio- Others Not applicable

witness visual
b. Consent will be obtained by: The informed consent will be obtained by the Principal
Investigator, Sridevi Roy
c. If AV consent is taken provide details on process and maintenance of privacy &
confidentiality: Not Applicable
d. Additional consent for genetic studies attached Yes  No /
NA
e. Waiver of consent requested Yes  No
f. Justify request for waiver: Not applicable
g. Has SUBJECT INFORMATION SHEET been submitted?  Yes No
h. Has Consent form been submitted?  Yes No
*Note that TWO documents have to be submitted – the SUBJECT INFORMATION SHEET
(explaining all about the study and written in ‘second person’) and the INFORMED
CONSENT FORM (where the subject states that he/she consents to participate and written in
‘first person’). Ideal subject information should include:
Simple & understandable language Insurance coverage
Statement mentioning that it is research Freedom to participate / withdraw
Sponsor of the study Information of research team, contact person
and Member Secretary, IEC.
Purpose and Methods (Duration & Statement that consent is voluntary
 frequency) of the study
Benefits to participant, community or others
Foreseeable risks, discomfort or
inconvenience
Confidentiality of information / records
Payment / reimbursement for participants
Adverse events / Study related injury
Alternative treatments and/or compensation
for participation or study related injury
Consent for future use of biological samples
and data including:
i) Current and future uses
ii) Period of storage and secondary use
iii) Sharing of data and biological materials
iv) Right to prevent use of biological
samples
v) Provision to safeguard confidentiality
vi) Post-research plan / benefit sharing
vii) Publication plan / photographs /
pedigrees

10. Details on Financial implications in the study:

(i) Who will bear cost of Medicine used in the study?
There will be no medicine used for the sake of the study.
(ii) Who will bear the cost of Investigations done on subjects during study
participation?
There is no investigation done on the subjects for the purpose of the study.
(iii) Who will bear the cost of travel for subjects?
Subjects who come for treatment purpose in the St. Johns Medical College and
Hospital, therefore, no travelling cost is involved for the sake of the study.
(iv) Are there any other costs potentially incurred by subjects of the study? (If yes,
Specify and state who will bear such costs)
No. there is no cost incurred by subjects for the sake of the study.
(v) Will the subjects receive FINANCIAL / OTHER MATERIAL BENEFIT for
participation in this study?
The subjects will not receive any financial or other material benefits for participation
in this study.
(vi) Is there a COMPENSATION FOR INJURY (sustained while participating in the
study) given by (Tick) Sponsor / Investigator / Insurance / any other means? If
YES, specify.
There is no compensation for injury as there is no risk for potential injury.
11. Details on Conflict of Interest (Financial interest also includes interest in a company that
would benefit from the approval of the test product)
a. Is there a conflict (financial / proprietary) of interest? YES  NO
b If the answer is YES, Explain: Not Applicable
12. Details on RECRUITMENT, INFORMATION DISCLOSURE, PRIVACY &
CONFIDENTIALITY:

(i) Will advertising be done for recruitment of participants YES  NO

(ii) Copy of posters, flyers, brochure, websites, others attached YES  NO
(iii) I will notify the sponsor and the IEC if there are any changes  YE NO
in the information disclosed herein that occur during the clinical S
trial / study and for one year following completion of the trial /
study
(iv) Participants linked with:
a. Direct Identifiers YES  NO
b. indirect Identifiers / Coded  YE NO
c. completely anonymized / delinked S
YES  NO
(v)In case of CHART REVIEW / RETROSPECTIVE STUDIES, please mention as to how
the identity of the patient is de-linked and how confidentiality is maintained? Explain.
NOT APPLICABLE

(vi)Does the research deal with sensitive aspects of the subject’s YES  NO
behavior such as sexual behavior, alcohol use or illegal conduct
such as drug use?
(vii)Could the information recorded about the individual, if got 
to be known outside the research:
 Place the subject at risk or criminal or civil liability? YES  NO
 Damage the subject’s financial standing, reputation or
YES  NO
employability; social rejection, lead to stigma, divorce etc?

(viii) Is confidentiality maintained in handling of data by staff?  YE NO

13. Documentation, Storage & Archival of study documents

i. Who will maintain the study documents?
The Principal Investigator (PI) will maintain the hard and soft copy of all the study related
documents.
ii. Where will the study documents be stored?
Personal e-mail and laptop of the PI. The guide and co-guide will be given access to the
data whenever asked.
iii. For how long will the data be stored?
The data will be stored for a period of 5 years after completion of the study.
iv. Who can access the records? Describe archived data access policy.
 The PI, Guide and Co-Guide.

14. Permission to collect data / conduct study:

i. Mention the names of Depts. and institutions or collaborating intramural department from
where samples/ data will be obtained.
 The study will be conducted Department of cardiothoracic surgery at
SJMCH, Bangalore.
ii. Permission letters from collaborating intramural Depts., institutions, health centre(s),
local Govt/administrative bodies etc. attached YES / NO
 Permission letter from Department of cardiothoracic surgery is obtained and
attached. The permission from department Heads will be obtained before the
initiation of the study.
iii. If the study is partially / fully conducted outside SJNAHS, describe the need.
 The entire study will be conducted in SJNAHS.

i. Application forwarded through HOD

(Signature of HOD with seal)

15. Details on RISK ASSESSMENT:

Is there a RISK?  YE NO
S
If YES is the risk reasonable compared to the anticipated  YE NO
benefits to Participants / community / country (Tick) S
Is the Risk / discomfort (Tick) Physical Social Psychological

Less than minimal risk YES/ NO YES/ YES/ NO 

RISK
NO
 CATEGORY Minimal risk  YES/ YES/ YES/ NO 
NO
NO
Minor increase over YES/ NO YES/ YES/ NO 
minimal risk or low risk NO
More than minimal risk or YES/ NO YES/ YES/ NO 
high risk NO
Risk category - Definition / description

Less than minimal risk

Probability of harm or discomfort anticipated in the research is nil or not expected. For example,
research on anonymous or non-identified data / samples, data available in the public domain, meta-
analysis, etc.
Minimal risk
Probability of harm or discomfort anticipated in the research is not greater than that ordinarily
encountered in routine daily life activities of an average healthy individual or general population or
during the performance of routine tests where occurrence of serious harm or an adverse event (AE) is
unlikely.
Minor increase over minimal risk or low risk
Increment in probability of harm or discomfort is only a little more than the minimal risk threshold. This
may present in situation such as routine research on children and adolescents; research on persons
incapable of giving consent; delaying or withholding a proven intervention or standard of care in a
control or placebo group during randomized trials; use of minimally invasive procedures that might
cause no more than brief pain or tenderness, small bruises or scars, or very slight, temporary distress,
such as drawing a small sample of blood for testing; trying a new diagnostic technique in pregnant or
breastfeeding women, etc. Such research should have a social value. Use of personal identifiable data in
research also imposes indirect risks. Social risks, psychological harm and discomfort may also fall in this
category.
More than minimal risk or high Probability of harm or discomfort anticipated in the research is
risk invasive and greater than minimal risk.

Declaration by the Principal Investigator:

I certify that the statements herein are true, complete and accurate to the best of my
knowledge. I am aware that any false, fictitious of fraudulent statement or claims may subject
me to criminal, civil or administrative penalties. I agree to accept responsibility for the
scientific conduct of the project and to provide the required progress reports as and when
required. I am aware that if there is a lapse in submitting the necessary documents to the IEC
or improper conduct of the study can lead to losing the approval of the study.

Date: Signature of PI:…………………

 LETTER SEEKING PERMISSION FROM THE HOD OF
DEPARTMENT OF CARDIOTHORACIC AND VASCULAR SURGERY, SJMCH
To,
The HOD
Department of Cardiothoracic and Vascular Surgery.
SJMCH, Bengaluru.
Through
The principal
St. John’s College of Nursing
SJCON, Bengaluru.
Subject: Requesting to grant permission to conduct the study
Respected Madam
I Sridevi Roy, 1st Year M.Sc NPCC Nursing student would like to obtain permission
to conduct my research study titled as “A study to assess the physical activity of post
operative cardiothoracic patients at the time of discharge in selected tertiary care
hospital, Bengaluru with a view to develop cardiac rehabilitation module” in your
departments.
I will be ever grateful to you for all your support and guidance. Kindly, consider
and do the needful.
Thanking You
Yours Faithfully

Sridevi Roy
1st M.Sc NPCC Nursing
NURSE PRACTITIONER AND CRTICAL CARE DEPARTMENT
SJCON, Bengaluru.

PARTICIPANT INFORMATION SHEET

STUDY TITLE: A study to assess the physical activity of post operative cardiothoracic
patients at the time of discharge in selected tertiary care hospital, Bengaluru with a view
to develop cardiac rehabilitation module.

I Sridevi Roy NPCC MSc Nursing student of SJCON, Bengaluru is conducting above
mentioned study along with the Guide of Mrs. Sugandhi D’Souza and Co-guide Dr. Sreekar
Balasundarum.

PURPOSE:

I am conducting a study to identify and understand the physical activity after heart and lung
surgery patients at the time of discharge to help you adjust into their regular day to day coping
skills, improving the recovery rate.

PROCEDURE:

If you are willing to participate in this study, you will be asked to do few activities like
coughing, sitting on the edge of the bed, standing with and without support, sitting in chair
from bed, walking few steps with or without support. On observing your physical activities I
will be able to assess your physical ability.

BENEFITS:

There is no direct benefit for you but your participation in this study will help to identify the
physical functioning after the surgery at the time of discharge which will be evaluated to plan
an instructional module for better well-being in home.

RISK:
There is no risk involved to you by participating in this study.

CONFIDENTIALITY:

The information provided by you will be kept confidential.

REFUSAL TO PARTICIPATE:

It is not compulsory that you have to participate in this study. Even after you consent for the
study, you are free to withdraw from it. Your decision to withdraw from the study will not
affect the treatment you are receiving.

PROBLEM OR QUESTIONS:

You will be given a copy of this form. If you have any problems or questions regarding the
study, please feel free to contact any of the investigators whose details are given below.

FINANCIAL CONSIDERATION:

You will not get any financial benefits, nor will you have to bear any expenses for the study.

IN CASE OF ANY QUERIES REGARDING THE STUDY PLEASE CONTACT:

Ms. Sridevi Roy
+91 9353040731
srideviroy1997@gmail.com
Mrs. Sugandhi D Souza
+91 9663645738
Reach2sugandhi@gmail.com
Dr. Sreekar Balasundarum,
+91 9986037868
sreekar73@gmail.com
For any clarification about your rights as a research subject, please contact:
Dr. JayanthiSavio
Member Secretary,
Institutional Ethics Committee (Ground Floor)
St. John’s Medical College,
Sarjapur Main Road, Bangalore: 560034
Phone Number: (080) 49466346/48 Email: sjmc.ierb@stjohns.in

INFORMED CONSENT FORM

Study title: A study to assess the physical activity of post operative cardiothoracic
patients at the time of discharge in selected tertiary care hospital, Bengaluru with a view
to develop cardiac rehabilitation module.

I confirm that I have read, understood and received a copy of the subject information sheet for
this study.

● I have been made aware of the purpose, procedures, risks and benefits of the study.

● I confirm that the study has been explained to me and I have had ample time and

opportunity to ask questions.

● I understand that my participation in the study is voluntary and that I am free to withdraw

at any time, without giving any reason.

● I understand that my identity will not be revealed in any information released to third

parties or published unless required by law.

● I agree not to restrict the use of any data or results that arise from this study provided such

a use is only for scientific purpose(s).

● I consent to participate in this study

Participant’s name Signature Date: DD/MM/YYYY

and Time (24 hr clock)
Person administering the Consent form: I confirm that I have explained all aspects of the study
to the subject (or legally acceptable representative).

Name of person authorized to Signature Date: DD/MM/YYYY

obtain consent and Time (24 hr clock)

Signature of the impartial witness:

Name of impartial witness Signature of impartial witness Date: DD/MM/YYYY

and Time (24 hr clock)

Curriculum Vitae

Name: Dr. Sreekar Balasundaram

Address: No.1633, 18th Main, 30thcross, Banashankari 2ndstage,
Bangalore-560070
Email Adress – sreekar73@gmail.com
Ph No: +91 9986037868

Secondary Education: St. Joseph’s Boys’ High School, Bangalore, India Language
of instruction: English.

Educational Qualifications

Degree Name of College Date of passing

Diploma in Fine Arts Santhanams Chitra Vidyalayam, 1987

Chennai

M.B.B. S St. Johns Medical College, Bangalore, India: Feb 1996

Bangalore University
M.S. J.N.MedicalCollege, Belgaum, India: Rajiv Sept 2000
(General Surgery) Gandhi University of
Health Sciences

D.N.B. Madras Medical College Nov 2001

(General Surgery) Hospital, Chennai, India: N.B.E,
New Delhi

D.N.B. Narayana Hrudayalaya Institute of Cardiac Nov 2005

(Cardiothoracic Sciences, Bangalore, India:
Surgery) N.B.E, New Delhi
 Experience in Cardiac Surgery

2002 –2005:
Enrolled into the Diplomate National Board (D.N.B) Cardiothoracic training
programme at Narayana Hrudayalaya Institute of Cardiac Sciences, Bangalore,
India, a premier Cardiothoracic Institute which performs over 6000 cardiac
surgeries annually, including paediatric and adult cardiac surgeries. His first
year in training involved harvesting saphenous veins, radial artery, sternotomy,
and chest closures. He was trained to assist all types of adult and paediatric
cardiac cases. The training also involved active participation in the departmental
seminars and symposiums, case presentations and mortality meetings. Managing
the out-patient department, the post-operative intensive care and the indoor
patients was also part of the training. The hospital has a 60-bedded adult and 45
bedded paediatric intensive care units.
During the second year of my training, he was trained to go on bypass, come off
bypass and perform simple congenital operations and valve replacements under
supervision of senior consultants. It was also in this period that he received
exposure to Thoracic surgery at the Tata Memorial Hospital in Mumbai, a one
of its kind oncology unit in the country, under Dr. R C Mistry. Here he assisted
various lung resections, mediastinal tumours, thoracoscopic procedures and
performed bronchoscopies and thoracotomies under supervision.

His third year of training involved independent preparation of

the patient for surgery including harvesting the internal mammary artery,
performing proximal anastomoses, performing independent valve replacements
and supervising junior surgeons to perform simple congenital cardiac surgeries
and valve replacements. He also assisted several aortic root procedures and
aneurysms during this period. His responsibility also involved taking teaching
rounds for junior registrars, lectures for the occupational therapists and clinical
perfusionists and decision making in the intensive care unit regarding re-
explorations and being part of the cardiac arrest emergency team. The hospital
also provides an excellent opportunity to harvest homograft valves through its
homograft laboratory.
2005 – 2007:
Clinical Assistant I –Till Dec2006 and Clinical Assistant II- From Jan 2007 to
December 2007 at Narayana Hrudayalaya Institute of Cardiac Sciences,
Bangalore
During this period he gained extensive experience in adult cardiac surgery
especially assisting off-pump and on-pump and emergency coronary bypass
surgeries. He have experience in using the intra-aortic balloon device in
emergencies. During this period he independently performed several valve
replacements, simple congenital anomalies and assisted complex adult (LV
Aneurysms, Pulmonary thromboendarterectomy, Valve Repairs) and paediatric
cases. My responsibility also involved managing the post-operative patients and
supervising junior registrars in the operating theatre.
2008-August 2009: Worked at The Royal Prince Alfred Hospital as a Senior
Registrar in the department of Cardiothoracic Surgery from January 21, 2008.
He was involved in all the major cardiac cases in the operating theatre including
coronary artery bypass grafting, valve replacements and repairs, complex aortic
root and arch surgeries, pulmonary endarterectomies and minor procedures
such as insertion of pacemakers and defibrillators. He also gained good
experience in managing all these cases post-operatively in the intensive care and
in the wards. He also had the opportunity to assist in a number of thoracic cases
including pneumonectomies, lobectomies, mediastinal masses, pleurodesis
procedures and VATS procedures. He has been actively involved in all their
teaching sessions, CME’s and monthly Surgeon’s meetings.
2009-Nov 2011: Consultant Cardiothoracic surgeon at Narayana Hrudayalaya,
Bangalore. Worked as an independent Consultant, handing simple and complex
Adult Cardiac surgeries including off-pump CABGs, Valve Replacements and
Repairs, Bentall procedures and simple Congenital Heart Diseases.

Nov2011-Mar2015: Consultant Cardiothoracic surgeon at Columbia Asia

Referral Hospital, Yeshwanthpur, Bangalore.
Handled independent Cardiac and Thoracic cases at the tertiary referral centre.

April 2015-Till date: Professor &HOD in the Department of Cardiothoracic

Surgery at St. John’s Medical College & Hospital

Registration Authority: Karnataka Medical Council, Bangalore, India

Registration number: 46669 (issued 21/05/1997)
Papers presented
1) Unusual RA mass - A case report - Presented at the 49th Annual Conference of
IACTVS (Hyderabad, India 2003)

2) Aortopulmonary Window Repair: Institution Experience – Presented at the

16th Biennial Congress of Association of Thoracic and Cardiovascular
Surgeons of Asia in (Bangkok, Thailand – November 2003)

3) AP Window with PDA and Interrupted Aortic Arch: A Case Report. -

Presented at the 50th Annual Conference of IACTVS (New Delhi, India 2004)

4) Intraoperative Risk factors for Respiratory Failure following C.A.B.G.-

Presented at the 50th Annual Conference of IACTVS (New Delhi, India 2004)

5) Tetrology of Fallot with Absent Pulmonary valve Syndrome - Initial

Institution Experience – Presented at the 51st Annual Conference of IACTVS
(Kochi, India 2005)

6) A rare case of high cardiac output failure - E-Poster Presentation

IACTSCON February 2017

7) A rare case of benign lung tumour - E-Poster Presentation IACTS CON

February 2017
8) The 67th Annual Conference of the Indian association of cardiovascular - thoracic
surgeons

A virtual symposium - IACTS CON 2021

9)The 68th Annual Conference of the Indian association of cardiovascular - thoracic

surgeons

A virtual symposium - IACTS CON 2022

Papers presented at the IACTSCON 2018, 31st Jan-4th Feb, Vishakhapatnam, India

A) E posters
i) Primary Malignant pericardial mesothelioma
ii) A bear attack with thoracic injuries
iii) When bleeding wins clotting: The surgical dilemma in life threatening
hemothorax in a Hemophiliac.
iv) Right atrial rupture and inferior pulmonary vein tear following blunt thoracic
trauma.
v) Non infant ALCAPA: A Surgical triumph

B) Paper presentations
i) Emergency valve surgeries in complicated infective endocarditis: Single centre
experience.
ii) Surgical interventions in complex pulmonary aspergilloma: A Single centre
experience

8) Papers presented at The IACTSCON 2019, Chennai

Mediastinal synovial sarcoma, a rare case presentation.

9) Papers presented at the IACTSCON 2020, Ahmedabad

Posters presented:

1. Interesting case of mediastinal follicular dendritic cell sarcoma (FDCS) and

mucocutaneous blisters.

2.Mediastinal masses with primary hyper parathyroidism (PHPT) - Two interesting cases.

3.A rare cause of cardiac tamponade in previously young healthy female

4.An Interesting case of hemoptysis

5.An interesting case of non-resolving hydropneumothorax.

6.A Clinicopathological study of Mediastinal masses at our Institute over the last 5 years.

7.A rare case of Chronic granulomatous lung mass; First case report.
 Paper Publications:
1) Hepatobiliary Cystadenoma with Mesenchymal stroma: A case Report Indian
Journal of Surgery Vol.63, No.1, 2001

2) A simple technique for securing gore-texneochordal height and knot slippage in

mitral valve repair. (co-author)
Journal of Cardiac Surgery . 09/2012; 27(5):554-6.

3) Tension pneumomediastinum in a patient with H1N1 pneumonia: A rare case

report. The Journal of Cardiothoracic Trauma. 2016 Jul 1;1(1):16.

4) When bleeding wins clotting: The surgical dilemma in life threatening

hemothorax in hemophilia Journal of Cardiothoracic trauma, Vol 3, Issue 1,
pgs20-23

5) Man versus wild: A case report of a bear attack with thoracic complications. The
Journal of Cardiothoracic Trauma. 2020 Jan 1;5(1):35.

6) Management of pseudo tumour in haemophilia patients. International Surgery

Journal. 2020 May 26;7(6):2033-5.

7) Thoracoabdominal Impalement Injuries-Case Report. Indian J Surg (2020).

https://doi.org/10.1007/s12262-020-02584-2

8) Chronic granulomatous aspergillus lung mass. Monaldi Archives for Chest

Disease 2020; Vol90:1371
Pgs:75-89

9) Hypertrophic Cardiomyopathy: A Practical Guide to Diagnosis and

Management. CRC Press; 2020 Dec 20. CRC Press/Chapter 6 (co-author)

10) Primary Malignant Synovial Tumor in the Mediastimum, Cureus 13(12):

e20076.doi:10.7759/cureus.20076(case report) (December 01,2021

11) Absent Testis with a Mediastinal Germ Cell Tumor, DOI: April 25, 2022,
10.7759/cureus.24472, e24472. doi:10.7759/cureus.24472

12) Idiopathic Extremity Arteriovenous Fistula: A Rare Etiology of Cardiac Failure,

DOI:10.7759/Cureus.28459

13) An uncommon aetiology for a common clinical problem: Primary pericardial

mesothelioma, The National Medical Journal of India, Vol,35,No.1,2022

14) Giant lung tumor in hereditary spherocytosis: inflammatory myofibroblastic

tumor-Indian Journal of Thoracic and Cardiovascular
 Surgery;http://doi.org/10.007/s12055-022-01464-6
CURRICULUM VITAE

PERSONAL DATA
Name :Mrs Sugandhi D’souza

Date of birth : 1 June 1971

st

Nationality : Indian

Educational qualification : M.Sc (N), M.Sc Medical Surgical Nursing

Registration No : R.N- 00054929

Address for communication : Mrs. Sugandhi D’ Souza,

St. John’s College of Nursing
Koramangala
Bangalore,
Karnataka.
Mobile: 9663645738

E-mail: reach2sugandhi@gmail.com

EDUCATION
Sl. Institution Qualification Conferred Year
No.
1. Ikon Nursing College M.Sc. Nursing 2012
Bangalore Specialty: Medical
Surgical Nursing
2 Indira Gandhi National Open P.C. B.Sc. Nursing 2005
University Bangalore
EXPERIENCE
S. Institution From To Positions held
No
1 St. John’s Medical College Hospital, 2021 Till Nursing
SJNAHS, Bangalore March date Superintendent

2 St. John’s College of Nursing, July 2018 2021 Assistant Professor

SJNAHS, Bangalore

2013 2018
Supervisory Nurse
2005 2013
Ward Incharge

1997 2005

3. St. John’s Medical College Hospital, April 1997 Staff nurse

Bangalore 1995

NATURE OF WORK
 Teaching subjects like Medical Surgical, for Post basic Bsc,(N).
 Guiding research projects for NPCC students.
 Carrying out administration work related to St. John’s Hospital.
 Guided and undertaken many researches.

MSc. THESIS TITLE

“A Study to Evaluate the Effectiveness of Planned Video Assisted Teaching
Programme on Cardio Pulmonary Resuscitation Among the Staff Nurses Working in
Selected Hospitals in Bangalore city.
 CURRICULUM VITAE
Educational:

Name Sridevi Roy

Nationality Indian

Date of Birth 02/05/1997

Permanent Address 4/7 H.B Road, A-Zone, City: Durgapur

West Bengal, Pin code: 713204

Present Address Minerva Living, 4th cross road,

Maruthi Nagar, Madiwala,
Bengaluru-560029

Phone Number 9353040731

Email Number srideviroy1997@gmail.com

Qualification:

Course University/ College /School Year Percentage

Board
Matriculation ICSE Carmel Convent School 2013 74%

Intermediate WBSCE Bidhan Chandra Institution 2015 68%

B. Sc RGUHS Vydehi Institute of Nursing 2020 73%
Nursing Sciences and Research Center

Work Experience

Hospital/ Institute Position From To

1. Manipal Hospital(MHB) ICU Nurse 10th March 2021 9th July 2023
HAL Old Airport Road, Bangalore