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CTRI Number  CTRI/2024/03/063924 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Effect of relaxation technique on stress and anxiety among infertile women 
Scientific Title of Study   A study to assess the effectiveness of relaxation technique in reducing the stress and anxiety among infertile women undergoing infertility treatment in selected IVF center at Meerut. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Chaudhary 
Designation  PhD Nursing Scholar 
Affiliation  College Of Nursing,Teerthanker Mahaveer University 
Address  Umalok college of nursing, Nursing department,Assistant professor, Bhatipura, garh road, Meerut
GP -28, Divider Road, Near PNB Bank ,Ganga Nagar, Meerut. UP:-250001
Meerut
UTTAR PRADESH
250001
India 
Phone  8273338222  
Fax    
Email  priyankac.scholar@tmu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ram Kumar Garg 
Designation  Professor/ PhD Guide 
Affiliation  College Of Nursing,Teerthanker Mahaveer University 
Address  Teerthanker Mahaveer College of Nursing,Community department,3rd floor Teerthanker Mahaveer University,Bagadpur, Moradabad. UP.
Teerthanker Mahaveer College of Nursing,Community department,3rd floor, Teerthanker Mahaveer University, Moradabad.
Moradabad
UTTAR PRADESH
244001
India 
Phone  9355641979  
Fax    
Email  ram.nursing@tmu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Ram Kumar Garg 
Designation  Professor/ PhD Guide 
Affiliation  College Of Nursing,Teerthanker Mahaveer University 
Address  Teerthanker Mahaveer College of Nursing,Community department, 3rd floor Teerthanker Mahaveer University,Bagadpur, Moradabad. UP.
Teerthanker Mahaveer College of Nursing,community department, 3rd floor Teerthanker Mahaveer University, Moradabad.
Moradabad
UTTAR PRADESH
244001
India 
Phone  9355641979  
Fax    
Email  ram.nursing@tmu.ac.in  
 
Source of Monetary or Material Support  
Teertanker Mahaveer College of Nursing, Teerthanker Mahaveer University 
 
Primary Sponsor  
Name  nil 
Address  nil 
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 Esha Khanuja  IVF Center Lokpriya Hospital  Lokpriya hospital,Samrat Palace, Garh Road,IVF center,3rd floor, Meerut-250003
Meerut
UTTAR PRADESH 		 6397456620
-
dreshakhanuja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
lokpriya permission letter  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: F419||Anxiety disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  No intervention 
Intervention  Experimental group  Relaxation technique (1 hr session) include 3 techniques of yoga and music 2 session per week for six weeks. 
 
Inclusion Criteria  
Age From  26.00 Year(s)
Age To  41.00 Year(s)
Gender  Female 
Details  INCLUSION CRITERIA: Infertile womens who are:
more then 3 years of married life.
available at the time of data collection.
willing to participate.
understand Hindi and English language.
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA: Infertile womens who are:
 
not willing to participate.
not available during the period of data collection.
with severe physical & mental illness.
conceive during intervention.
less then 26 years of age.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To assess the level of stress and anxiety among infertile women undergoing infertility treatment before administration of relaxation technique in both experimental and control group.
2)To plan and administer the relaxation technique sessions to the experimental group.
 		 7wks
 
 
Secondary Outcome  
Outcome  TimePoints 
1) To evaluate the effectiveness of relaxation technique on reduction of stress and anxiety among experimental and control group.
2) To compare the level of stress and anxiety after administration of relaxation technique between experimental and control group.
3) To find the association between pre-test intervention scores of stress and anxiety with the selected demographic variables of infertile women.
 		 3wks 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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 2 
Date of First Enrollment (India)   20/03/2024 
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="0"
Months="1"
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyankac.scholar@tmu.ac.in].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  		 PHASE 1:- PRE-TEST   ( ADD AFTER CRC 2 )
One week will use to collect information regarding demographic data ,InfertilityRelated Stress Scale (IRSS)
and  Generalized Anxiety Inventory (GAD-7). Pretest will do in both experimental and control group each with 60 samples
, before intervention of relaxation technique.
PHASE –II :- INTERVENTION
 In experimental group relaxation technique will provide which include yoga techniques for 10 min each and music therapy for 15 min, by conducting 2session/ week for 6weeks, for one hour. And follow up will do daily basis by what’s app messages and information.
PHASE III:- POST-TEST
 After 6 wks  of intervention of relaxation technique post-test will collect form both the group.In experimental group researcher ensure that each participant receive 6-7 session before give the post test.




 
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