| CTRI Number |
CTRI/2025/11/097778 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
“Study on the Benefits of a Nurse-Led Meno yoga Support Program for Women with Menopause Problems in Rural Areas” |
|
Scientific Title of Study
|
Effectiveness of nurse facilitated peer support group intervention on menopausal symptoms among perimenopausal women residing in selected rural villages |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Gnana Deepa |
| Designation |
Assistant Professor |
| Affiliation |
Dr.M.G.R Medical University |
| Address |
Assistant Professor
Claudine college of nursing,
Medical Surgical Department
First floor, Room number-10
Chellampatti
Aathoor TK,
Dindigul dt 624211,
Tamil Nadu,
INDIA
Assistant Professor
Claudine college of nursing,
Medical Surgical Department
First floor, Room number-10
Chellampatti
Aathoor TK,
Dindigul dt 624211,
Tamil Nadu,
INDIA
Dindigul
TAMIL NADU
624211
India |
| Phone |
08526652097 |
| Fax |
|
| Email |
deepagnana85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sara Sapharina |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
Sri Ramachandra Faculty of nursing
Department of Mental Health Nursing
Room Number 19 First floor
SRIHER (DU) PORUR
CHENNAI - 600116
Sri Ramachandra Faculty of nursing
Department of Mental Health Nursing
Room Number 19 First floor
SRIHER (DU) PORUR
CHENNAI - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9894279745 |
| Fax |
|
| Email |
sarajohn.g@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sara Sapharina |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
Sri Ramachandra Faculty of nursing
Department of Mental Health Nursing
Room Number 19 First floor
SRIHER (DU) PORUR
CHENNAI - 600116
Sri Ramachandra Faculty of nursing
Department of Mental Health Nursing
Room Number 19 First floor
SRIHER (DU) PORUR
CHENNAI - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9894279745 |
| Fax |
|
| Email |
sarajohn.g@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Gnana Deepa - Self Funded
Claudine college of nursing
chellampatti
Aathur taluk
Sitharevu Po
Dindigul Dt
India
624211 |
|
|
Primary Sponsor
|
| Name |
Gnana Deepa - Self Funded |
| Address |
Claudine College of Nursing
Chellampatti
Dindigul Dt. 624211 |
| Type of Sponsor |
Other [Claudine College of Nursing] |
|
|
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 |
| P Gnana Deepa |
Villages under Batlagundu Block |
Batlagundu
Dindigul dt
624202
Dindigul
TAMIL NADU |
8526652097
deepagnana85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Block Development officer, Batlagundu |
No Objection Certificate |
| SRIHER (DU) |
Approved |
| Theni Medical College. Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Perimenopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse facilitated peer support group intervention |
Researcher will demonstrate the simple and specific yoga including yogic poses, breathing exercises.
Participants will be provided with specific yoga video demonstration prepared by researcher also Pamphlet Education - Education on Perimenopause –Psycho-Physiological changes and the yoga poses will be given by the researcher.
Once the participants learn the yoga techniques, they will be encouraged to do the yoga regularly with the peer group support which will be monitored by the researcher through WhatsApp group by sending the update everyday.
Yoga Demonstration:
Yoga demonstration at selected villages for 45 minutes 3 times per week for 12 weeks. Yoga demonstration (45 minutes) includes
MENO YOGA TECHNIQUES
Solar Yoga Flow – an energising yoga asana to remove heat and reduce anxiety 20 mins
Lunar Yoga Flow – a calming yoga asana for feelings of depletion, low energy and/or low mood:10mins
Restorative Yoga and Yoga Nidra leading in to savasana: 10mins
|
| Comparator Agent |
Routine care |
Education on perimenopause - Psycho physiological changes |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women Who are willing to participate
Women Who are available during data collection
|
|
| ExclusionCriteria |
| Details |
1. Women who were already practicing yoga for a month or more,
2. Women with surgical menopause and receiving any kind of hormone therapy
3. Women with mental illness.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in menopausal symptoms |
45th day & 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in sleep quality
Enhanced quality of life
Reduced stress & anxiety |
45th day
90th day |
|
|
Target Sample Size
|
Total Sample Size="428"
Sample Size from India="428"
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)
|
04/12/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [deepagnana85@gmail.com].
- For how long will this data be available start date provided 30-10-2029 and end date provided 30-10-2070?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Effectiveness
of nurse facilitated peer support group intervention on menopausal symptoms among
perimenopausal women residing in selected rural villages
1. To
assess the menopausal symptoms among perimenopausal women.
2. To
determine the quality of life among perimenopausal women
3. To evaluate
the effectiveness of nurse facilitated peer support group
intervention on menopausal symptoms among perimenopausal women
4. To find
out the association
between menopausal symptoms with selected
background variables among perimenopausal women.
Hypothesis Nurse
facilitated peer support group intervention will reduce menopausal symptoms among
perimenopausal women. |