PARTICIPANTS’ INFORMED CONSENT FORM

Dear participant,

Warm greetings of the day!

I am Ms. Mamta Parihar, (PhD Scholar Geetanjali University Udaipur), Lecturer Govt. College of Nursing,
Jodhpur. You are invited to take part in this study because it intends to impart knowledge on adapting healthy
methods for menstrual hygiene. The participation in this research study is entirely voluntary and it will involve
your participation in answering questionnaire which will take about 15 to 20 minutes. Your active participation
will help us to evaluate the acceptability and performance of a menstrual cup versus conventional methods for
menstrual hygiene.

Name of the Principal Investigator: Mamta Parihar

Participant’s Identification No: ______________________________________________________________

CERTIFICATE OF CONSENT

I, _________________________________D/o or W/o___________________________________________

R/o ________________________________________________________________give my full, free,

voluntary consent to be a part of the study-Title - “ Acceptability and performance of menstrual cup versus
conventional methods for menstrual hygiene in reproductive age group women in selected states of
India.” the procedure and nature of which has been explained to me in my own language to my full
satisfaction. I confirm that I had the opportunity to ask questions. I understand that my participation is
voluntary and I am aware of my right to opt-out of the study at any time without giving any reason.

I understand that the information, pictures and audio/video recordings collected about me and any of my
medical records may be looked at by a responsible individual from the Principal investigator or regulatory
authorities. I permit these individuals to have access to my records and publish the results of the study.

Date: ______________

Place: _____________ Signature/Left thumb impression

This is to certify that the above consent has been obtained in my presence.

Date: ________________
Place: ________________ Signature of Principal Investigator/Witness if available
 PARTICIPANTS’ INFORMATION SHEET

STUDY TITLE- Acceptability and performance of menstrual cup versus conventional methods for menstrual
hygiene in reproductive age group women in selected states of India.

PRINCIPAL INVESTIGATOR- Mamta Parihar

PURPOSE OF THE RESEARCH STUDY- The study will help to create an awareness regarding menstrual
hygiene in women in addition to assess the acceptability and performance of menstrual cup versus
conventional methods of menstrual hygiene in reproductive age group women.

WHY PARTICIPANT IS SELECTED-Because you fulfill the inclusion and exclusion criteria of the study.

STUDY PROCEDURES AND VISIT SCHEDULE- Women with the willingness to understand the
educational training to manage their menses will be contacted by the researcher initially only baseline data
will be collected and after three months of use of menstrual cup you will be contacted by the PI to share their
experiences using a menstrual cup and pads/cloth.

WITHDRAWAL FROM STUDY-You can withdraw from the study anytime you want. Nobody will force
you to participate in the study

POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES- There are no major risks however if
any women would get any issues with the use of the menstrual products, they will be meticulously explained
about the use and hygiene.

POTENTIAL BENEFITS-The study will help us to find about the acceptability, performance, and quality
of life of women after using a new method of menstrual hygiene. In addition to this, the awareness training
program will help women to learn and get sensitized about a new method for menstrual hygiene.

CONFIDENTIALITY OF STUDY AND MEDICAL RECORDS- All the data related to the study and
records will be kept confidential.

COST OF PARTICIPATION-There is no cost to participate in the study.

RESEARCH RELATED INJURIES AND COMPENSATION- There will be no physical or mental

injuries related to the study however if the participants will encounter any health issues immediate medical or
psychological aid will be provided by the Principal Investigator.

WHO TO CONTACT IF YOU HAVE QUESTIONS- Mamta Parihar,

Mobile No.- 9529794077

Mail ID – mamtaparihar2011@gmail.com
 Code No…………
Screening Proforma: It will include all inclusion criteria with yes or no option this screening will be done
verbally. Kindly mark (✓) in front of appropriate column.

S. No. Parameters Yes No

1. Women with a regular menstrual cycle (If your menstrual cycle is coming every
month regularly)
2. Any known silicon allergy
3. Any reproductive tract infection
4. Any plan to become pregnant during the study
5. Any Medical illness
6. Any Psychiatric illness

Section A: Socio-demographic data.

Note: Please read every statement carefully and select the response that best fits your situation.

1. Age (in years) - ………………………………………………………………………………………………...

2. Marital Status. Unmarried/ Married / Widow / Separated…………………………………………………….

3. The number of pregnancies in the past- Never / Once / Twice / More than twice / …………………….…..

4. Religion - Hindu /Muslim / Christian / Any other...............................................................................................

5. Educational qualification –

No formal education / Up to Primary / Senior Secondary / Graduate / Post Graduate............................................

6. Occupation –........................................................................................................................................................

7. Monthly Income (In Rs.) – ……........................................................................................................................

8. The money, you spend on buying sanitary protection products each month. (In Rs.) –

I can’t afford to buy/ less than 50 / 50-100 / 100-150 / More than 150 / ………................................................

9. Name of the place you live-……………………………………………………………………………………

10. Hand washing facility – Not available / only water available / Soap & water both available/. ………………

11. Did you ever face any problem due to the trash of used menstrual products in toilets at home / work /

school / college or anywhere else? - Yes / No / Sometimes……….......................................................................

Menstrual history and Menstrual hygiene product you used (in past)
12. Age (in years) when the first menstrual period started.
a) Before 12
b) 12-14
c) After 14 [ ]
13. Duration of menses
a) 1-2 Day
b) 3-4 Days
c) 5 Days
d) More than 5 Days [ ]
14. On your heaviest days of flow, how frequently do you change the sanitary products?
a) Once
b) Twice
c) Thrice
d) More than three times [ ]
e) Others (if you want to specify) …………………………………
15. Did you use any of the following methods in the past for managing menstrual flow? (Select all that
apply)
a) Tree leaves [ ]
b) Mud [ ]
c) Cow dung [ ]
d) Plastic bags [ ]
e) Newspaper [ ]
f) Tissue paper [ ]
g) Cloth [ ]
h) None of the above [ ]
i) Any other (If you want to specify)................................................
16. Which method do you use at present for managing menstrual flow? (Select all that apply)
a) Cloth [ ]
b) Pads [ ]
c) Tampons [ ]
d) Menstrual Cup [ ]
e) None of the above [ ]
f) Any other (If you want to specify)................................................
17. Which method do you use for disposing of the menstrual waste products? (Select all that apply)
a) Burning [ ]
b) Throwing away (Anywhere) [ ]
c) Flushing [ ]
d) Dispose of in the dustbin [ ]
e) Burial/dumping [ ]
f) Any other (if you want to specify) ……………………………………………………….
18. Did you already know about the menstrual cup?
a) Yes
b) No [ ]
19. Do you want to use a menstrual cup?
a) Yes
b) No
c) I used it in past, now I don’t want to use it
d) I want to use it but I am afraid to use
e) I am already using a menstrual cup [ ]
20. If not, would you like to share the reason/ reasons or any other concerns of yours? (Record)
………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………
 Section B: Likert Scale for assessing acceptability regarding the sanitary pad or cloth
Note: - Kindly read the statements and tick (✓) mark in the appropriate column against each statement that is
applicable. Each statement has four alternatives as Strongly agree, Agree, Disagree, Strongly disagree.

S. No Statements Strongly Agree Disagree Strongly

agree disagree
1. I am satisfied with my present menstrual hygiene method.
2. Using a sanitary pad/cloth (the product which absorbs the
blood) may lead to infection, if not changed every 3-4
hours.
3. I would prefer using a sanitary pad or cloth over a
menstrual cup.
4. Sanitary Pad is convenient to get from the market.
5. I can easily afford to buy Sanitary Pads or cloth.
6. A Sanitary pad is more economic than the other methods of
menstrual hygiene.
7. My parents /guardians or partner support me using a
sanitary pad or cloth.
8. I would recommend sanitary pads or cloth to my
friends/family members.
9. I did not use any other method for managing blood flow
while using a sanitary pad or cloth.
10. Sanitary pad or cloth is hygienic to use.
11. Sanitary pad or cloth is an environmentally friendly
method.
12. Sanitary pad or cloth is an overall acceptable method for
managing menstrual hygiene.
Section C: Likert scale to assess the performance of sanitary pad or cloth
S.No Statements Strongly
Agree Disagree Strongly disagree
agree
1. A sanitary pad or cloth is easy to use.
2. Wearing/Placement of a sanitary pad or cloth is easy.
3. The removal of a sanitary pad or cloth is easy.
4. The cleaning of sanitary pads or cloth can be done easily.
5. The disposal of menstrual waste is hassle-free and easy
with a sanitary pad or cloth
6. sanitary pad or cloth leads to leakage of blood.
7. Sanitary pad or cloth leads to rashes or redness around the
vaginal skin.
8. Sanitary pad or cloth leads to itching inside or around the
vaginal skin.
9. Sanitary pad or cloth leads to vaginal dryness.
10. Sanitary pad or cloth leads to burning sensation around
the vaginal skin.
11. I like that sanitary pad is not reusable.
I like that cloth is reusable.
12. Overall, I am comfortable to use a sanitary pad or cloth.
13. Overall, I am satisfied with the performance of sanitary
pad or cloth
 User instructional Manual
Healthy methods for menstrual hygiene

What is Menstrual Cycle

Monthly bleeding is a sign of reproductive health and maturity. Each woman with normal physiology generally
starts to show sign of menstrual bleeding after the age of 12 which last for a period of 40 to 50 years of age.
There are a variety of products available for managing the menstrual cycle. They are clothes, sanitary pads,
tampons, and menstrual cups.
What are the alternative methods for menstrual hygiene?
1. Menstrual cloth
2. Reusable pad
3. Disposable pad
4. Tampon
5. Menstrual cup
1. What is a menstrual cloth?
Cloths are reusable pieces of fabric worn externally to the body, in underwear, or tied to the waist to absorb
menstrual flow. They are made from either newly purchased pieces of fabric (mostly cotton) or old fabric
repurposed from clothing or another use. There is no guidance on how long cloths can be reused, but it is
generally agreed that this should be for no longer than 1 year. They are consumables and require regular
assessment of supply, availability, and affordability. It is cheap and available in most contexts. Proper washing
and drying are crucial for safe use, though often difficult due to lack of privacy and stigma. Training on good
user practice, provision of soap, underwear, and storage bags, and the availability of private places for washing
and drying is important. The thickness, color, absorbency, and softness of fabric, drying time, and the number
of pads provided is important to consider. The provision of underwear is crucial as girls and women often do
not own underwear. This is of particular importance in emergency settings
2. What is a reusable pad?
Reusable pads are worn externally to the body in the underwear, to absorb menstrual flow and are held in
place usually by snaps. They are made from a variety of natural or synthetic materials. After use, they are
washed, dried, and re-used for approximately one year. They are consumables that require regular
assessment of supply, availability, and affordability.

Reusable cloth pad Non reusable sanitary pad.

3. What is a disposable pad?
Disposable pads are worn externally to the body in the underwear to absorb menstrual flow. They are disposed
of after a maximum of 8 hours; they are therefore consumables that require regular assessment of supply,
availability, and affordability. Pads come in various sizes, absorbencies, and materials and consist of a layered
design made of blends of plastics, rayon, and cotton. Pads should include wings to prevent leakage and keep
the pad more securely in place
 4. What is a tampon
Tampons are absorbent materials made from cotton and/or rayon that are inserted into the vagina to absorb
menstrual flow. They expand with moisture and thereby avoid leakage. They can be worn for up to 8 hours,
after which they are removed using the removal string, and disposed of. They come in a variety of sizes,
materials and with or without an applicator to assist insertion. Tampons are consumables that require regular
assessment of supply, availability, and affordability

5. What is a menstrual cup

A menstrual cup is a type of feminine hygiene product that is usually made of medical-grade silicone, shaped
like a bell, and is flexible. It is worn inside the vagina during menstruation to catch or to collect menstrual
fluid (blood). About every 4–12 hours (depending on the amount of flow), the menstruating woman removes
the menstrual cup from her vagina, empties the collected menstrual blood into a toilet or sink, washes the cup
under running water, and inserts it again. At the end of the monthly period, the cup can be sterilized, usually
by boiling it in water. In concise, it is a silicon device that is worn in the vagina to collect menstrual

Reasons to use menstrual cups:

1. Save the planet. The consensus of manufacturers is that menstrual cups have a lifetime expectation of
10 YEARS!! On the other hand, you need to use a new tampon roughly every 8 hours and you need to
change your sanitary pad several times a day. Just imagine how much "garbage" you'll avoid making by
using a menstrual cup!
2. Save money (considering the cost of tampons & sanitary pads). A menstrual cup cost roughly 600 –
1100 Rs. That equates to 10 years to deal with your menstruation.
3. Protect your body as well as the delicate pH level of your vagina from the toxic elements contained in
tampons and sanitary napkins. Chlorine in your vagina? Or on your sensitive vulva? That can irritate
both you and your skin.
4. Sleep without a sanitary napkin the size of a dictionary wedged between your legs.
5. Get in touch with your body.
6. Deal with your menstruation just 2 times a day. You only need to empty a menstrual cup every 12 hours!
How about that!
7. Avoid toxic shock.
8. Be happy.
Steps to using a menstrual cup
➢ Hold the menstrual cup with clean hands.
➢ Press menstrual cup tightly.
➢ Fold the menstrual cup in half (You may use both hands in the process).
➢ Press the menstrual cup tightly to hold it in place.

How to wear a menstrual cup?

➢ There are a variety of positions you can try to comfortably wear the menstrual cup. Some women find it
better to squat; others prefer it in the shower.
➢ Try to wear it smoothly and as fast as you can - the more hesitation you have the more difficult it will be
as the menstrual cup will keep opening up too soon. Practice, making the unfamiliar familiar, will help a
lot. Soon you will be doing it in seconds!
➢ Aim towards the bottom of your spine. The vaginal canal is not vertical or horizontal, it slopes upwards.
If you are not familiar with the slope of your canal, try it with a finger to see in what direction you
should be inserting.
➢ You only need to push the menstrual cup in as far enough so that the knob remains outside the entrance
of your vagina.

Before wearing the cup After wearing the cup

 How to check after wearing?
You should feel the menstrual cup unfold inside as soon as you have pushed it in. Some women find it is
better to let the cup unfold when it is just inside, and then to push it slightly further in - this creates a gentle
"suction" which means there will be no leakage. If your cup does not unfold, try relaxing your pelvic
muscles and using your index finger to check around the sides of the inserted cup. It may be necessary to
give the menstrual cup a gentle turn to create the seal. You can feel your menstrual cup by touching and
feeling the knob by your index finger when you will bear down however if properly worn, you should not
be able to feel your menstrual cup at all.

How to remove menstrual cup?

Wash your hands thoroughly with warm/cold water and soap. Take any of the following comfortable
positions:
• Standing
• Sitting on the toilet seat
• Squatting

Insert your thumb and index finger to reach the knob; Slide upwards and pinch the base of the cup firmly;
Squeeze the cup gently and remove it by tilting it sideways to release the air; Empty the contents into the
toilet and wash the menstrual cup with soap and water.

How to clean a menstrual cup?

DURING THE MENSTRUAL CYCLE
Wash menstrual cup with hot/cold water; Take soap and water; Wash menstrual cup with a soap to get a
rich lather; Rinse it well to clean it thoroughly.

BEGINNING AND END OF THE MENSTRUAL CYCLE:

Boil the menstrual cup for twenty (20) minutes in water to sterilize it.

IN EMERGENCY/TRAVEL
If the sterilization of the menstrual cup (20 minutes) is not possible, ensure to clean it thoroughly as per
directions before use.

How to Store menstrual cup?

At the end of your cycle, wash, sterilize, dry, and store the menstrual cup in the cotton drawstring bag
provided. Do not store it in a plastic bag or an air-tight container.

Note: If you encounter any problem or query you can contact the following.
Name – Mamta Parihar
Mobile No. 9529794077
Email. ID mamtaparihar2011@gmail.com