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CTRI Number  CTRI/2025/09/094328 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [NURSING]  
Study Design  Other 
Public Title of Study   Effectiveness of comprehensive self care supervised intervention package on distress and lifestyle factors in primary infertile women 
Scientific Title of Study   Effectiveness of comprehensive self care supervised intervention package on distress and lifestyle factors in primary infertile women visiting infertility centre at selected tertiary hospital in Goa 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ekta Karkal 
Designation  PhD Scholar 
Affiliation  KLE Academy of Higher Education and Research 
Address  Department of Nursing KLE Academy of Higher Education and Research, Institute of Nursing Sciences, Nehrunagar- Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  8806129439  
Fax    
Email  ektakkl0112@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sangeeta Kharde 
Designation  Dean, Department of Nursing 
Affiliation  KLE Academy of Higher Education and Research 
Address  Department of Nursing KLE Academy of Higher Education and Research, Institute of Nursing Sciences, Nehrunagar- Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  09481322656  
Fax    
Email  sangeeta.kharde@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ekta Karkal 
Designation  PhD Scholar 
Affiliation  KLE Academy of Higher Education and Research 
Address  Department of Nursing KLE Academy of Higher Education and Research, Institute of Nursing Sciences, Nehrunagar- Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  8806129439  
Fax    
Email  ektakkl0112@gmail.com  
 
Source of Monetary or Material Support  
Ekta Karkal Self Funding KLE Academy of Higher Education & Research Belgavi Karnataka 
 
Primary Sponsor  
Name  EKTA KARKAL 
Address  KLE Academy of Higher Education and Research, Nehrunagar, Belgavi- Karnataka, India 590010 
Type of Sponsor  Other [Self ] 
 
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 
Dr Ajit Nagarsenkar  Hospicio- South Goa District hospital, Margao-Goa  Infertility Clinic, South Goa District Hospital in Goa.
South Goa
GOA 		 09822168778

tijanagarsenkar@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary infertile women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive self care supervised intervention package  A structured and validated programme covering the areas of handling distress and managing lifestyle factors specially developed for primary infertile women. The experimental group will receive the Comprehensive self care supervised intervention package.The study will take place for 60 days. 
Comparator Agent  Routine hospital care  Here the control group will receive routine hospital care and pamphlet regarding lifestyle and distress management. the duration is for 60 days 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.The participants of the study are primary infertile women
2.Attending the infertility centre at district hospitals of Goa.
3.Who are in the age group of 25 to 40 years.
 
 
ExclusionCriteria 
Details  1.Women having co morbid medical conditions like diabetes and hypertension and cardiac conditions.
2.Women having history of psychological disorders and on treatment.
3.Already under going infertility treatment for more than a year.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in psychological distress levels as measured by standardized DASS 21 point scale after the intervention.  At day 0, Day 30, Day 60 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in lifestyle factors:

Dietary habits

Physical activity levels

Sleep quality

BMI or weight management 		 1 year 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   01/10/2025 
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 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  

       In the studies it reveals that women with infertility have been reported to have poor psychological status in terms of trait anxiety and depressive symptoms compared to women without infertility.[5] Hence, women who have psychological distress, anxiety, and depression often are reluctant to use psychotropics and seek nonpharmacological therapies.[9] 

      All the studies have especially emphasised the importance of adopting fertility-supporting lifestyle behaviours aimed at eliminating infertility risk factors, and have indicated that this may affect infertility self-efficacy perceptions positively.

In this endeavour, it is believed that fertility-supporting health training given to infertile women will contribute to their self-efficacy perceptions.In the view of these context, the present study is undertaken to evaluate the effectiveness of comprehensive self care supervised intervention package on distress and lifestyle in primary infertile women   on changing lifestyle behaviours improved infertility self efficacy perceptions.

 

 

 
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