| CTRI Number |
CTRI/2025/09/094542 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Menstrual practices among diabetic female |
|
Scientific Title of Study
|
Menstrual hygiene practices and their effect on the physical and mental well being of diabetic females-An interventional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saaranyaa S |
| Designation |
Postgraduate student |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Dr Saaranyaa S
1st year Postgraduate student,
Department of Community Medicine,
Sri Ramachandra institute of higher education and research
Porur,
Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
7373756562 |
| Fax |
|
| Email |
saaranyasree@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Pankaj B Shah |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra institute of Higher Education and Research, Porur |
| Address |
Dr Pankaj B Shah
Professor,
Department of Community Medicine,
Sri Ramachandra institute of Higher Education and Research,
Porur,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7550208565 |
| Fax |
|
| Email |
pankajbshah@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saaranyaa S |
| Designation |
Postgraduate student |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Dr Saaranyaa S
1st year Postgraduate student,
Department of Community Medicine,
Sri Ramachandra institute of higher education and research
Porur,
Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
7373756562 |
| Fax |
|
| Email |
saaranyasree@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of higher education and research,
Porur,
Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
Dr Saaranyaa S |
| Address |
Dr Saaranyaa S,
First year Postgraduate student,
Department of Community medicine,
Sri Ramachandra institute of higher education and research,
Porur,
Chennai-600116 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saaranyaa S |
Sri Ramachandra institute of higher education and research |
Sri Ramachandra institute of higher education and research-rural health and training centre-room number-22 ,
department of community medicine,
Porur,
Chennai
Porur,
Chennai-600116
Chennai
TAMIL NADU |
7373756562
saaranyasree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra institute of higher education and research institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Menstrual practice -Educational intervention |
Diabetic female who are menstruating perimenopausal phase and menopausal period are selected and educational interventional is given for one day.Followed by this a time interval of 2 weeks given after completing this 2 weeks gap Post intervention is done by using the same questions as tested among them |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
All female peoples aged more than 18 years with Diabetes attending RHTC of Sri Ramachandra institute of higher education and research and who give consent for the study |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to participate in the study
2. Patients with no history of Diabetes mellitus
3. Patients who are Pregnant |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in menstrual hygiene practices, measured using a structured questionnaire at baseline and at 2 weeks post-intervention |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in PMS symptoms score, stress levels (PSS), sleep quality (PSQI), quality of life (WHOQOL-BREF), and perceived family support, assessed at baseline and at 2 weeks post-intervention |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="381"
Sample Size from India="381"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study titled “Menstrual Hygiene Practices and Their Effect on the Physical and Mental Well-Being of Diabetic Females – An Interventional Study” is being conducted among diabetic women attending the Rural Health and Training Centre of Sri Ramachandra Institute of Higher Education and Research, Chennai.
The background recognizes that diabetic females face unique menstrual challenges including irregular cycles, increased susceptibility to infections, stress, poor sleep quality, and lack of family support. Despite this, there is limited research focusing on menstrual hygiene practices in this group.
The study aims to assess menstrual hygiene practices, menstrual waste management, premenstrual symptoms, sleep quality, stress levels, quality of life, and family support among diabetic women, and to evaluate the effect of a short educational intervention (pamphlets in local language and videos) on improving these parameters.
A sample size of 381 has been calculated, of which 100 participants (25%) will receive the intervention. Data will be collected using validated instruments including MPNS-36, DRSP, WHOQOL-BREF, PSS, PSQI, and MSPSS.
-
Primary outcome: Change in menstrual hygiene practices.
-
Secondary outcomes: Changes in PMS symptoms, stress, sleep quality, quality of life, and perceived family support.
Outcomes will be assessed at baseline and at 2 weeks post-intervention.
This short-term study will provide important insights into menstrual health needs of diabetic females, and this simple health education strategies can improve awareness, hygiene practices, and psychosocial well-being. |