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CTRI Number  CTRI/2022/05/042362 [Registered on: 04/05/2022] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   sexual and Reproductive health of women with mental illness 
Scientific Title of Study   Effectiveness of sexual and reproductive health training programme on knowledge and coping strategies of women with mental illness– A mixed method study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S Vijayalakshmi 
Designation  Clinical Instructor/PhD Scholar 
Affiliation  National institute of mental health and neurosciences 
Address  Department of OBG (Nursing Division) 3rd Floor, Room Number: 307 College of Nursing National Institute of Mental health and Neurosciences (NIMHANS) Hosur Road, Bangalore-29

Bangalore
KARNATAKA
560029
India 
Phone  9964279151  
Fax    
Email  viji_msc2004@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DR Radhakrishnan 
Designation  Associate Professor 
Affiliation  National institute of mental health and neurosciences 
Address  Department of Nursing (Psychiatry division) Ground floor, Room no:G7 College of Nursing Building National institute of mental health and neurosciences (NIMHANS) Hosur road Bangalore-29

Bangalore
KARNATAKA
560029
India 
Phone  9342135545  
Fax    
Email  dr.rk76@hotmail.com  
 
Details of Contact Person
Public Query  
Name  S Vijayalakshmi 
Designation  Clinical Instructor/PhD Scholar 
Affiliation  National institute of mental health and neurosciences 
Address  College of Nursing Department of OBG (Nursing division) 3rd floor, Room number:307 National institute of mental health and neurosciences (NIMHANS) Hosur road Bangalore-29

Bangalore
KARNATAKA
560029
India 
Phone  9964279151  
Fax    
Email  viji_msc2004@yahoo.co.in  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neurosciences 
 
Primary Sponsor  
Name  S Vijayalakshmi 
Address  Clinical Instructor/PhD Scholar College of Nursing National Institute of Mental health and Neurosciences 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
S Vijayalakshmi  National Institute of mental health and Neurosciences  Mental health out patient department Division: Psychiatry First floor, Room Number: F14 Hosur road Bangalore-29
Bangalore
KARNATAKA 		 9964279151

viji_msc2004@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee (Behavioural Science Division)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F068||Other specified mental disorders due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Information education and communication material on sexual and reproductive health   Participants will be recruited as per inclusion and exclusion criteria. Pre test will be done on the day of recruitment followed by Information education and communication material on sexual and reproductive health will be provided to the participants. (This IEC material contains information about family planning, sexually transmitted infections, sexual health and sexual violence by intimate partner). Participants will be called after two months for the follow up and the post-test will be done.  
Intervention  Sexual and reproductive health training program  Participants will be recruited as per inclusion and exclusion criteria. Pre test will be done on the day of recruitment and Sexual and reproductive health training program will be provided to the participants. (The training program contains information about modern and traditional method of family planning, signs and symptoms of sexually transmitted infections, high risk sexual behavior and its prevention, sexual health information, appropriate referral services for intimate partner sexual violence and coping strategies). The duration of intervention will be one hour. After one month first follow up will be done and the intervention will be repeated. Then after one month second follow up will be done and the intervention will be repeated followed by post-test. Total 3 times the intervention will be provided. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Women with mental illness who were

Diagnosed and registered in NIMHANS as per International classification of diseases-10 (ICD), and the duration of illness not less than one year.
Who scored between 24-30 in Mini Mental status examination scale.
Married and aged between 18-49 yrs and attended OPD in NIMHANS.
Able to communicate English, Tamil, Kannada with the interviewer
 
 
ExclusionCriteria 
Details  Women with mental illness who were having

Intellectual disability as per clinical examination
Hearing and speech disorder.
Brief Psychiatric Rating Scale (BPRS) Score≥ 18
Not willing to participate in this study 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in the knowledge, coping strategies of sexual and reproductive health among women with mental illness after 2 months   Three interventions in two month time duration  
 
Secondary Outcome  
Outcome  TimePoints 
To improve the knowledge on various methods of family planning
To make them aware of signs and symptoms of sexually transmitted infections
Information on sexual health
Appropriate referral services and coping strategies for intimate partner sexual violence  		 Three interventions in two month time duration  
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/05/2022 
Date of Study Completion (India) 09/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This study is an experimental study to evaluate the effectiveness of sexual and reproductive health training program on  knowledge and coping strategies of women with mental illness. Participants was recruited from  mental health outpatient department of tertiary care psychiatry hospital from Bangalore India. The primary outcome of the study is to improve the knowledge and coping strategies of sexual and reproductive health. Participants  recruited by simple random sampling technique using random table to experimental and control group. Pretest was conducted for both the group. Experimental group received intervention on sexual and reproductive health training program whereas control group was received information education and communication material on sexual and reproductive health. Post assessment was done after 2 months for both the group during next follow up. The secondary outcome will be to improve the knowledge on various methods of family fanning, signs and symptoms of sexually transmitted infections, information on sexual health, appropriate referrals and coping strategies for intimate partner sexual violence.

 
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