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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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