| CTRI Number |
CTRI/2025/12/098380 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
a quasi-experimental study to assess the Effectiveness of perimenopausal empowerment strategies on psychological wellbeing and perimenopausal symptoms among perimenopausal women. |
|
Scientific Title of Study
|
A quasi-experimental study on Effectiveness of perimenopausal empowerment strategies on psychological wellbeing and perimenopausal symptoms among perimenopausal women in selected hospital, Mangaluru. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tenzin wangmu |
| Designation |
student |
| Affiliation |
Yenepoya colllege of nursing |
| Address |
floor no.5th, room no.6, lecture hall 2, OBG department Yenepoya college of nursing
Naringana Mangaluru
Pin no;57518, India
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
09148156268 |
| Fax |
|
| Email |
w4036827@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mrs. Amisha Amin |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya colllege of nursing |
| Address |
Yenepoya nursing college
Department of obstetrics and gynecological nursing, Naringana,Mangaluru
Dakshina Kannada
Karnataka
575018
India
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9380189436 |
| Fax |
|
| Email |
amishaamin42@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Tenzin wangmu |
| Designation |
student |
| Affiliation |
Yenepoya colllege of nursing |
| Address |
floor no.5th, room no.6, lecture hall 2, OBG department Yenepoya college of nursing
Naringana Mangaluru
Pin no;57518, India
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
09148156268 |
| Fax |
|
| Email |
w4036827@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical college hospital |
|
|
Primary Sponsor
|
| Name |
yenepoya medical college hospital. |
| Address |
Yenepoya Medical College Hospital, derelakatte
pin no. 575018 (Mangaluru) |
| Type of Sponsor |
Private medical college |
|
|
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 |
| yenepoya medical college hospital |
Yenepoya Medical College hospital |
Seminar Hall,
Female Nursing Office (FNO) & Housekeeping Section,
Room No. 6,
Ground Floor,
Health Services Block,
University Campus,
Deralakatte,
Mangaluru – 575018, Karnataka Dakshina Kannada KARNATAKA |
09148156268
w4036827@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yec3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
perimenopausal empowerment strategies for psychological wellbeing and perimenopausal symptoms
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Perimenopausal empowerment strategies |
A two-day Perimenopausal Empowerment Strategies Program involving education and mind–body practices to improve psychological wellbeing and reduce perimenopausal symptoms.
Format & Duration:
Group sessions, 60 minutes/day for 2 days.
Day 1:
Educational session on perimenopause, symptom management, lifestyle modification, sleep hygiene, and coping strategies.
Day 2:
Mind–body wellness session including simple breathing exercises, gentle yoga postures, guided relaxation, and mindfulness.
Follow-up:
Daily motivational text messages for 15 days after completion.
Delivery:
Facilitated by the investigator in the seminar hall using simple language and basic teaching aids. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
A Perimenopausal women
Who are between the age group of 40 to 55years
Perimenopausal women working as FNO and housekeeping in YMCH
Who are willing to participate in the study
Who are able to understand and speak Kannada English and Hindi |
|
| ExclusionCriteria |
| Details |
Women who are currently undergoing medical treatment for perimenopausal symptoms or stress management hormonal replacement therapy, consuming Estrogen supplement
History of psychiatric or endocrine disorders that could interfere with the studys outcomes
Women with physical disabilities such as hearing, speech or mobility impairments and those with cognitive or intellectual disabilities are excluded as the study involves active participation and self administered questionnaires that require clear communication comprehension and mobility |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in psychological wellbeing |
0day,21 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce in severity of perimenopausal symptoms |
0day, 21 day |
|
|
Target Sample Size
|
Total Sample Size="98" Sample Size from India="98"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
23/12/2026 |
| 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="11" 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 - NO
|
|
Brief Summary
|
Perimenopause is a natural but often challenging transition in a woman’s life, marked by hormonal changes that may lead to symptoms like mood swings, anxiety, sleep problems, and hot flashes. Many women—especially those with limited awareness or support—suffer silently during this period, affecting their psychological well-being and overall quality of life. This quasi-experimental study aims to assess the effectiveness of empowerment strategies in improving psychological well-being and reducing perimenopausal symptoms among working women aged 40–55 years, specifically female nursing orderlies and housekeeping staff at Yenepoya Medical College Hospital, Mangaluru. A total of 98 women will be selected using purposive sampling and divided equally into control and intervention groups. The intervention group will receive two structured 1-hour empowerment sessions over 2 days covering topics like education on perimenopause, lifestyle changes, sleep hygiene, psychological and emotional wellbeing, practical coping techniques (such as yoga and deep breathing). Daily motivational messages will reinforce the intervention for 15 days. Data will be collected using the WHO-5 Wellbeing Index and the Menopausal Rating Scale. Statistical analysis will include paired and unpaired t-tests, and chi-square tests to assess the impact of the intervention. Findings from this study may inform low-cost, holistic approaches for improving the health and quality of life of perimenopausal women through workplace-based interventions. |