RESEARCH PROPOSAL

Dr. S.R. Chandrasekhar Institute of Speech and Hearing, Bangalore

PROPOSED TITLE

RELIABILITY OF VIRTUAL ASSESSMENT OF SWALLOWING IN

NEUROTYPICAL ADULTS AND IN INDIVIDUALS WITH DYSPHAGIA -
A PILOT STUDY

RESEARCHER

Mr. Abhilash Ghadei

Reg.No: AS201001

2nd YEAR MASLP

(Dr. S.R. Chandrasekhar Institute of Speech and Hearing ,Bengaluru-560084)

A Research Proposal Submitted In Part Fulfillment of the Final Year MASLP

(Master’s Degree in Audiology and Speech-Language Pathology)
(Dr. S.R. Chandrasekhar Institute of Speech and Hearing, Bangalore)

GUIDE
Ms. Mereen Rose Babu
Assistant Professor
Department Of Speech Language Studies
(Dr. S.R.Chandrasekhar Institute of Speech and Hearing, Bangalore, 560084)
Year: 2020-2022
RELIABILITY OF VIRTUAL ASSESSMENT OF SWALLOWING IN
NEUROTYPICAL ADULTS AND IN INDIVIDUALS WITH DYSPHAGIA -
A PILOT STUDY

BACK GROUND AND JUSTIFICATION

Dysphagia is defined as difficulty in swallowing food (semi-solid or solid), liquid, or both.
Neurological, muscular, anatomical, and/or psychological factors may predispose a person to
difficulty in swallowing. Difficulty in swallowing or dysphagia can lead to serious complications
including aspiration pneumonia, malnutrition, and death if not diagnosed early. (Wieseke, Bantz,
Siktberg, Dillard,2008).Timely access to speech pathology services for dysphagia assessment
and management can be restricted, especially in India those who live in rural or remote areas.
Difficulty accessing services can be impacted by factors such as distance, transportation,
mobility, and financial issues. In addition, shortage of available specialists can limit the actual
services available along with this now the current condition of pandemic(Covid-19) greatly
limits the sector of offline speech and language services.

For fulfilling the above necessities we can think to relay on tele-practice on dysphagia, though
there are a list of factors for Indian scenario, like lack of evidence based practices ,inadequacy of
infrastructure and idea for tele-services, reliability of e-platforms for conducting the program and
adequate internet connectivity which may affect the overall efficacy still the approach can help to
overcome a handful list of necessities that we have already mentioned above.The incidence of
conditions that predispose an individual to dysphagia, such as cerebral vascular accident,
Parkinson’s disease, dementia, multiple sclerosis, gastroesophageal reflux disease, tumors, and
stricture is life threatening and can also increase the risk of mortality. Early dysphagia screening
can reduce these complications. Difficulty in swallowing or dysphagia can lead to serious
complications including aspiration pneumonia, malnutrition, and death if not diagnosed early.  In
many hospitals, dysphagia screening is performed by speech–language therapists but in India the
extent of the early identification is very much less

INTRODUCTION
The COVID-19 pandemic has challenged our ability to manage dysphagia. Both swallowing
evaluation and treatment sessions typically involve close physical proximity between the patient
and the clinician, as well as several aerosol-generating actions or tasks, such as production of
reflexive or voluntary cough, etc.Though a very limited evidence based studies are there on tele-
approach on swallowing disorders, some previously done studies explain the reliability and
validity of tele assessment for dysphagia.
However, there have not been much literatures explaining the feasibility of conducting subjective
assessment through tele mode in neurotypical individuals as well as individuals with dysphagia.
Hence, the accuracy with which we can observe the swallowing skills through tele mode needs to
be explored more.

REVIEW OF LITRATURE
Sharma,Ward,Burns,Theodoros,Russell(2011)conducted a research that provided pilot
information on the basic feasibility and validity of conducting dysphagia teleassessments , using
CSE protocol they assessed swallowing difficulties for 10 stimulated patients(actors portraying
patient)via online mode and for same subjects face to face assessment was also done , while
comparing the results revealed high to excellent levels of agreement between the T-SP and the
FTF-SP across all parameters of the CSE(Clinical Swallowing examination).
Ward,Sharma,Burns,Theodoros ,Russell(2012) after a pilot study, they conducted
teleassessment on 40 individuals with dysphagia from various etiologies were assessed
simultaneously by a face-to-face speech-language pathologist(FTF-SLP) and a telerehabilitation
SLP (T-SLP) via an Internet-based videoconferencing telerehabilitation system, using CSE
protocol . The results showed that a CSE conducted via telerehabilitation can provide valid and
reliable outcomes comparable to clinical decisions made in the FTF environment. This study thus
indicates the possibility of carrying out the swallowing assessment through tele mode.

However, further research is needed to assess the system’s capabilities and limitations with a
larger and more diverse patient population to determine if subgroups(adults and geriatrics)
perform differently in the online environment. In addition, development of a system that can
enable remote clinical and instrumental assessment of patients would further enhance the clinical
accuracy of dysphagia assessments via telerehabilitation. The current data contribute to the
growing evidence base that supports the delivery of speech pathology services via
telerehabilitation and the potential for telerehabilitation to enhance access to health services for
patients with dysphagia. From the study, there is a need for further research to establish best
practice models or a generalized protocol for implementing telerehabilitation services for
dysphagia, and to evaluate the cost benefits of these across different health-care environments
(acute care, residential age care) and differing international health-care.

Coyle(2012)studied on various aspects of problems that are seen in aspiration pneumonia ,which
is associated issue with swallowing disorders.In his study he explained the advantages of tele-
dysphagia approach that can save the cost of patients , overcome the availability of swallowing
therapists and also discussed about the future opportunities of tele-dysphagia.This study also
emphasized on need to carry out tele therapy of swallowing.
This study more over concentrated on swallowing difficulties in aspiration pneumonia ,and
benefits of tele mode for them.
There is a need to carry out the study on other group of population as well for getting more
generalized outcomes. Other than benefits we need to explore the challenges that might occur
during tele mode of dysphagia.

Cassel(2016) investigated the comparison of the outcomes of traditional face-to-face dysphagia

intervention (defined as the treatment of swallowing disorders) to remote, online tele-dysphagia
(telehealth) intervention in Geriatric TBI and CVA Populations. The 30 population-based,
randomly assigned participants ranged in age from 65 to 90 years of age, with a formal diagnosis
of dysphagia secondary to either traumatic brain injury or stroke (CVA). 30 sessions of therapy
were given both in tele mode and traditional offline mode to the patients and after the analysis of
results they found both modes of service delivery facilitated effective and successful outcomes,
with tele-dysphagia demonstrating slightly increased effectiveness(7%).Results suggest that
online tele-dysphagia intervention may be an effective option for those individuals with limited
service access due to mobility or distance restraints – specifically geriatric populations with a
diagnosis of TBI / CVA.
Establishing the long-term benefits of the instruction and use of swallowing strategies via tele-
dysphagia intervention has yet to be determined, and warrants further research. These findings
are indeed preliminary, since only three cases were reported, which limits the ability to
generalize findings to other populations or disorders. Additionally, analysis was performed on
only the first 30 trials, the minimum number completed by all participants. Further research
should target a larger sample size and a broader range of populations, increased trials, long-term
benefits, and most importantly, an ongoing comparison of in-person and tele-dysphagia
interventions. Challenges occurring during tele mode for geriatric population can be taken into
consideration for future studies .

Malandraki, Roth, Sheppard(2016)conducted a study on pediatric dysphagic patients .

The study was a case report. Outcome variables included behavioral, swallowing and quality of
life variables, and were assessed at baseline and at the end of the four-week program. Selective
variables were also assessed at a follow-up family interview four weeks post program
completion. Over the four-week intervention period, the patient demonstrated substantial
improvements in: oral acceptance of eating-related objects and a variety of foods (behavioral
variable), timing of voluntary saliva swallows and aerophagia levels (swallowing variables) and
quality of life. Follow-up interview analysis showed that most skills were retained or improved
one-month post intervention. This intensive telepractice program proved to be feasible and
effective for this pediatric patient with dysphagia.

Despite the promising results of the present case report, there are limitations that need to be
considered. First, this is a single case, which significantly limits the generalizability of the results
and of this telepractice program.. Furthermore, many of the variables measurements were based
on a small number of trials of a specific task and thus, valid pre-post statistical comparisons is
not there. Furthermore, some of the measurements we completed were based on the mother’s
responses and thus may include bias. There is a lack of testing the reliability and validity of
mother’s responses.

Georgia,Malandraki,Arkenberg,Mitchell,Malandraki(2020)conducted a rapid systematized

review of 40 articles to identify telehealth adaptations during COVID-19, according to peer-
reviewed articles published from January to August 2020. They found One article focused on
telehealth and dysphagia during COVID-19.The remaining 10 mentioned telehealth in varying
degrees while focusing on dysphagia management during the pandemic. No articles discussed
pediatrics in depth.The most common procedure for which telehealth was recommended was the
clinical swallowing assessment(8/11), followed by therapy (7/11). Six articles characterized
telehealth as a second-tier service delivery option. Only one article included brief guidance on
telehealth-specific factors, such as legal safeguards, safety, privacy, infrastructure, and
facilitators. Literature published during the pandemic on telehealth for dysphagia is extremely
limited and guarded in endorsing telehealth as an equivalent service delivery model.

NEED OF THE STUDY

Reviews for the current study explains that there is a very limited evidence explaining the
efficacy and accuracy with which we can observe the swallowing skills through tele mode, and
that needs to be explored more.
This brings to the need of the study to observe the swallowing skills in tele mode and report the
accuracy of each task in both healthy young adults and dysphagic population.
Lack of a standard protocol for swallowing screening in tele mode also brings another need for
conducting our study , which will give us a evidence based practice model for tele assessment for
swallowing. Current study will be helpful for developing a screening protocol for teleassessment
of dysphagia that can be used for clinical population.

This study will provide pilot information on the basic feasibility and validity of conducting
dysphagia assessments via tele mode.

This study will compare the reliability of tele assessment between neurotypical and dysphagic
individuals and will explore whether there is any variation or similar level of reliability in both.

Outcomes of the study will be helpful to evaluate the challenges that might occur during tele
mode of swallowing evaluation.

This study will compare the reliability of tele assessment between neurotypical and dysphagic
individuals and will explore whether there is any variation or similar level of reliability in both.

AIM OF THE STUDY

To check the reliability of subjective assessment of swallowing in tele assessment mode and
explore its feasibility in analyzing these skills in healthy young adults as well as in adults with
dysphagia, by conducting a pilot study.

OBJECTIVE OF THE STUDY

To perform water swallow test and Manipal Manual of Swallowing Assessment in both
neurotypical and dysphagic population in tele mode.

To send the video recording of swallowing assessment to 3 Speech and Swallowing therapists
with 8 years of experiences ,who will score for the tests from the recorded session based on their
perception.

To check the inter rater reliability and inter rater agreement from the rating/scoring of the 3
raters.
METHOD
Target population

-The participants will be divided into two group.

-First group included neurotypical individuals ranged in age from 20-50 years.

-Second group also includes same age range of individuals (20- 50 years) but with swallowing
difficulties.

Sample size calculation

-This pilot study will be conducted on 5 neurotypical individuals and 5 people diagnosed with
dysphagia which is decided after discussion with statistician.
( Sharma,Ward,Burns,Theodoros ,Russell,2011)

Inclusion Criteria

-The included neurotypical individuals shouldn’t have any associated neurological conditions
and no reported cognitive impairments.

-The dysphagic population having swallowing difficulties due to any associated neurological
condition or any other medical conditions will be included.

-Participants in this study are not required to have any knowledge or skills associated with
computers and technology and are not required to control the system at any point during the
assessment session.

-All participants should be between 20-50 years of age.(Roman,Lin,Kwiatek,Pandolfino,

Kahrilas,2010)

Exclusion criteria

-Individual those who have obvious/reported, cognitive/communicative impairment will not be

included under neurotypical group for the study .

-Dysphagic population associated with high medical dependency, those who have moderate–
severe levels of cognitive impairment as indicated within their medical history, with any severe
motor dysfunction,dexterity issue , musculoskeletal issues will not be included and anyone with
significant auditory or visual impairments were excluded.
(Ward,Sharma,Burns,Theodoros ,Russell,2012),(Warner,2009)
-People other than 20-50 years age range will not be included in the study.

ROOM AND SUBJECT PREPARATION

ROOM PREPARATION

1-Lighting
-Adequate lighting should be there so that visibility of clients face should not be interfered ,
patient should avoid sitting in front of a bright window, which has the effect of causing the
camera to underexpose and create a dark silhouette.
2-Background
-Single colored background is preferable to avoid visual distractions during close observations .
3-Camera angle
 -Best suitable position is to have the camera at a height that it can be angled just slightly down at
the patient. and have it pointed down at patient’s eyes. Position should not be too close or far
with respect to screen.

-Camera should be at eye level of straight and normal camera angle

4-Client and laptop position

-Client can sit in a normal position in any chair or sitting tools according to their convenience.
the laptop should be positioned in a way that will convenient for the ideal visibility of patients
face.

5-Arrangement of Dietary items

-A table with different food consistency according to NDD(National Dysphagia Diet)standards

can also be kept ready prior to the beginning of assessment. (Sharma et al,2011)

NEED OF AN ASSISTANT

-As per Sharma et al(2011) the telerehabilitation assessment procedure involved the use of an
assistant at the patient end to assist the SLP to conduct the assessment.

-An assistant will be required for helping the subject during several task completion, any of the
subjects friends or family member can do the role.

-Assistant will be oriented about the overall assessment procedure and the included tasks . Proper
instruction will be given when we need their help during the session.

-Assistant in this study should have normal cognitive development and are required to have
some basic knowledge or skills associated with computers and technology.
MATERIALS

1)Laptops [Computers equipped with online videoconferencing software(ZOOM) that used high-
quality audio and video compression]

2)Finger Pulse Oximeter

3)3.5 mm headset

4)Surgical Tape

5)Dietery items( Foods and fluids will be taken based on the National Dysphagia Diet
recommendations)

6)Other required items

SUBJECT PREPARATION

Specific modifications will be made to this existing system to enhance the visual and auditory
information along with some other arrangements required for a tele assessment .

These include the following points: 

1. Visual information – Clarity in visualizing client

2. Auditory information – Clarity in conversational speech

3.Other preparations

-An pulse oximeter will be placed on the finger of the client and the SpO2 level will be
measured.

-During the assessment, the assistant will aid the SLP with the oromotor and laryngeal function
examination and food and fluid trials and also will be repositioned the camera.

COVID SAFETY MEASURES

-Both participant and assistant will perform hand wash and sanitization before and after
performing tasks.

-All materials(dishes,table,chair,laptop etc )will be sanitized before and after the session.

-The assistant will use non woven disposable gloves ,face mask and cap through out session and
will remove(from behind) when required .(Kumar 2021).
-Assistant will maintain a proximity from the participant and will change his position when
required.

-If any discomfort shown by the participants as well as assistant then required break will be
given.

-Appropriate ventilation will be checked and session will be carried out in comfortable room
temperature.( Helmenstine,2020)

-More precaution will be taken by assistant while performing some special tasks (aerosol
generating tasks like voluntary reflexive cough, and touching mucosal surface of participant.
(Kumar ,2021)

OTHER PRECAUTIONARY MEASURES

-Participant should not be on nil per mouth.

-Pulse oximetry measurement will be done in the first 3 minutes of swallowing assessment

-Participant and Caretaker should be informed well about procedures first and consent from the
patient will be taken.(information sheet and consent form is attached in ANNEXURE)

-Food , fluids and water will be taken for the assessment , consistency of food and fluid is taken
based on NDD levels.

-No new food consistency which the patient is not comfortable with will be included in the
study.

PROCEDURE INVOLVED

-The tele-assessment session will be carried out by the author for 10 samples(5 neurotypical and
5 dysphagic) using an online videoconferencing platform(zoom) required help will be provided
by the assistant .

-The recording of the session will be sent to 3 experienced swallowing therapist at least having 5
years of experience(HSIEH, HSUEH, CHIANG,LJN 1998).

-The judges will be blind folded to the condition of participant (neurotypical or dysphagic).They
have to score for each task according to their perception for recorded session based on the
MMSA scores and water swallow test values.

-From the scoring of the three judges/raters , Inter rater reliability (IRR) and Inter rater
agreement(IRA) will be evaluated.
-IRA indices, relate to the extent to which different raters assign the same precise value for each
item being rated. In contrast, IRR indices relate to the extent to which raters can consistently
distinguish between different items on a measurement scale.(Gisev,Bell,Chen 2013)

-The required non parametric test will be finalized later after discussion with statistician.

Subjective Why to use this Scoring Reference

Swallowing test
Assessment

1)Manipal It is a standardized Detailed Scoring the values Kumar,Bhat(2012)

Manual of test tool. It provides as mentioned in the manual
Swallowing understanding of
Assessment key issues and
basic concept upon
All the sub sections which actual
and tasks under assessment builds
them will be on
administered in
online mode

2)Water Swallow Gold Standard test Score the drinking profile Horiguchi,suzuki(2011)
Test of 30 ml to effectively 1) Volume/swallow
Standardized measure 2) Time/swallow
protocol will be swallowing 3) Swallowing effiency
followed for efficiency.
conducting the test
during the tele
assessment session

3)Pulse oximeter Evidence based The number of events of Morgan,

method for oxygen de saturation (2%- Omahoney,Francis
(1)Pre-swallowing indicating risk for 5%) across the three time (2008)
baseline oxygen aspiration periods (pre-swallowing,
saturation levels during swallowing, post-
swallowing may be
taken over a 3
indicative of an aspiration
minute rest-period; event.
(2) Oxygen
saturation levels
taken during 3
minutes of
swallowing;
(3) Post-
swallowing
baseline oxygen
saturation levels
taken over a 3
minute rest-
period

ETHICAL CONSIDERATIONS

-Informed consent form will be acquired from every participant of the study. Participants within
th age range of 20-50 years old will be considered for the study therefore parental consent is not
necessary.

-Participant’s confidentiality will be maintained.

STATISTICAL ANALYSIS

-The required non parametric test will be finalized later after discussion with statistician.

RESULTS

-The expected result will evaluate the validity and reliability of tele assessment of swallowing
disorders,a high level of feasibility is expected in tele mode of dysphagia assessment.

IMPLICATIONS OF STUDY

-Current study will give an idea for developing a screening protocol for teleassessment of
dysphagia that can be used for clinical population.

-This study will provide pilot information on the basic feasibility and validity of conducting
dysphagia assessments via tele mode.

-Outcomes of the study will be helpful to explore and overcome the challenges that might occur
during tele mode of swallowing evaluation.

-This study will compare the reliability of tele assessment between neurotypical and dysphagic
individuals and will explore whether there is any variation or similar level of reliability in both.

References:

Gisev, N., Bell, J. S., & Chen, T. F. (2013). Interrater agreement and interrater reliability: Key
concepts, approaches, and applications. Research in Social and Administrative Pharmacy, 9(3),
330-338. https://doi.org/10.1016/j.sapharm.2012.04.004
Cassel, S. G. (2016). Case reports: Trial dysphagia interventions conducted via
Telehealth. International Journal of Telerehabilitation, 8(2), 71-
76. https://doi.org/10.5195/ijt.2016.6193

Satar, H. M. (2013). Multimodal language learner interactions via desktop videoconferencing

within a framework of social presence: Gaze. ReCALL, 25(1), 122-
142. https://doi.org/10.1017/s0958344012000286

Dammers, R. J. (2009). Utilizing internet-based videoconferencing for instrumental music

lessons. Update: Applications of Research in Music Education, 28(1), 17-
24. https://doi.org/10.1177/8755123309344159

Roman, S., Lin, Z., Kwiatek, M. A., Pandolfino, J. E., & Kahrilas, P. J. (2011). Weak peristalsis

in Esophageal pressure topography: Classification and association with dysphagia. American
Journal of Gastroenterology, 106(2), 349-356. https://doi.org/10.1038/ajg.2010.384

Comparison between inter-rater reliability and inter-rater agreement in performance

assessment. (2010, August 1).
ResearchGate. https://www.researchgate.net/publication/46256628

Skre, I., Onstad, S., Torgersen, S., & Kringlen, E. (1991). High interrater reliability for the
structured clinical interview for DSM-III-R Axis I (SCID-I). Acta Psychiatrica
Scandinavica, 84(2), 167-173. https://doi.org/10.1111/j.1600-0447.1991.tb03123.x

HSIEH, C., HSUEH, I., CHIANG, F., & LIN, P. (1998). Inter-rater reliability and validity of the
action research arm test in stroke patients. Age and Ageing, 27(2), 107-
113. https://doi.org/10.1093/ageing/27.2.107

Cassel, S. G. (2016). Case reports: Trial dysphagia interventions conducted via

Telehealth. International Journal of Telerehabilitation, 8(2), 71-
76. https://doi.org/10.5195/ijt.2016.6193

Wieseke, A., Bantz, D., Siktberg, L., & Dillard, N. (2008). Assessment and early diagnosis of
dysphagia. Geriatric Nursing, 29(6), 376-383. https://doi.org/10.1016/j.gerinurse.2007.12.001

Screening tests in evaluating swallowing function - Med. (2019, May 3).

PDF4PRO. https://pdf4pro.com/view/screening-tests-in-evaluating-swallowing-function-med-
5aeccd.html

Cassel, S. (2016). A comparison of traditional face-to-face and tele-dysphagia instructional

methods in geriatric TBI and CVA populations. Archives of Physical Medicine and
Rehabilitation, 97(10), e16-e17. https://doi.org/10.1016/j.apmr.2016.08.046
Cassel, S. (2016). A comparison of traditional face-to-face and tele-dysphagia instructional
methods in geriatric TBI and CVA populations. Archives of Physical Medicine and
Rehabilitation, 97(10), e16-e17. https://doi.org/10.1016/j.apmr.2016.08.046

Malandraki, G. A., Arkenberg, R. H., Mitchell, S. S., & Malandraki, J. B. (2021). Telehealth for

dysphagia across the life span: Using contemporary evidence and expertise to guide clinical
practice during and after COVID-19. American Journal of Speech-Language Pathology, 30(2),
532-550. https://doi.org/10.1044/2020_ajslp-20-00252

Coyle, J. (2012). Tele-dysphagia management: An opportunity for prevention, cost-savings and

advanced training. International Journal of Telerehabilitation, 41-
46. https://doi.org/10.5195/ijt.2012.6093

Sharma, S., Ward, E. C., Burns, C., Theodoros, D., & Russell, T. (2011). Assessing swallowing

disorders online: A pilot Telerehabilitation study. Telemedicine and e-Health, 17(9), 688-
695. https://doi.org/10.1089/tmj.2011.0034

Morgan, A. T., OMahoney, R., & Francis, H. (2008). The use of pulse oximetry as a screening
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38. https://doi.org/10.1080/17518420701439910

ANNEXURE
-Patient Information Sheet

Dr. S. R. Chandrasekhar Institute of Speech & Hearing

Hennur Main Road, Bangalore - 560084.

Tel: 080-25460405/25470037/25468470 Fax: 080-25467829

Email: dr.srcish@gmail.com Web: www.speechear.org

Patient Information sheet

You have been invited to participate in a research study. Before participating in this study, it is
important that you take time to read and understand the information in this Information Sheet.
Research Title:
RELIABILITY OF VIRTUAL ASSESSMENT OF SWALLOWING IN NEUROTYPICAL
ADULTS AND IN INDIVIDUALS WITH DYSPHAGIA - A PILOT STUDY .

Introduction:
Dysphagia is defined as difficulty in swallowing food (semi-solid or solid),liquid or both. Early
diagnosis and intervention should must be needed for the patients. As COVID-19 pandemic has
made us to choose a tele mode of clinical services, we are conducting a study to check the
efficacy of swallowing assessment in tele mode.

Purpose of Study:
To check the reliability of subjective assessment of swallowing in tele assessment mode and
explore its feasibility in analyzing these skills in healthy young adults as well as in adults with
dysphagia, by conducting a pilot study.

What will the study involve?

For this purpose the researcher will require 1 session of interactions which will be carried out
virtually using online meeting platform (ZOOM). During this time researcher will be recording
the video session when you are performing certain tasks. This will include carrying out a list of
tasks like swallowing of water, having certain food items, tongue movement, puffing of cheek
etc. and the assistant will be helping you during the session. The recorded session will be used to
fulfill the research purpose.

Risks and Benefits:

There is no direct benefit for you in participating in this study. However, your participation could
help us in gaining information regarding virtual assessment of swallowing disorder using in
future.
There is no risk for you in participating in this study.

Do I have to participate?
Participation in this study is voluntary. If you agree to take part, then you will be asked to sign
the “Informed Consent Form”. You will be given a copy of the form and this Information Sheet.
Any services you will not be affected if you decide not to participate in this study.
If you decide to participate, you can still withdraw from the study without penalty. Your data
will not be used and will be discarded.
Data & Confidentiality:
The data from this study will be made into a report which may be published. Access to the data
is only by the research team and Dr.SR Chandrasekhar of Speech and Hearing Institute. The data
will be reported in a collective manner with no reference to an individual. Hence your identity
will be kept confidential.
Payment and compensation:
You do not have to pay and you will not be paid for participating in this study.
Who can I ask about the study?
If you have any questions, you can direct them to the research team. You can also contact the Dr.
SR CISH for clarifications.
Researcher name- Abhilash Ghadei
- Informed Consent Form

Dr. S. R. Chandrasekhar Institute of Speech & Hearing

Hennur Main Road, Bangalore - 560084.

Tel: 080-25460405/25470037/25468470 Fax: 080-25467829

Email: dr.srcish@gmail.com Web: www.speechear.org

Informed Consent Form

Research Title: ..................................................

Researcher’s Name: .........................................

I, ………………………………………, ID No: …………………......

• have read the information in the Participant Information Sheet including information
regarding the purpose and procedure of this study
• have been given time to think about it and all of my questions have been answered to my
satisfaction.
• understand that I may freely choose to withdraw from this study at anytime without reason
and without repercussion
• understand that my anonymity will be ensured in the write-up.
I voluntarily agree to be a part of this research study, to follow the study procedures, and to
provide necessary information to the researcher as requested.

………………………………. …………………..

(Signature) (Date)