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CTRI Number  CTRI/2024/12/078153 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 21/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Effectiveness of Yoga Nidra 
Scientific Title of Study   Effectiveness of Yoga Nidra on Stress and Insomnia among postmenopausal women in self-help groups at 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  Ms PREETHA SONIA DSOUZA 
Designation  post graduate student (Nursing) 
Affiliation  Father Muller College of Nursing 
Address  Father Muller College of Nursing, Obstetrics and Gynaecological Nursing, 1st Msc Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India

Dakshina Kannada
KARNATAKA
575002
India 
Phone  8861893796  
Fax    
Email  soniapreetha86@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Ramyashree S 
Designation  Assistant Professor 
Affiliation  Father Muller College of Nursing 
Address  Father Muller College of Nursing, Obstetrics and Gynaecological Nursing Department, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7349426322  
Fax    
Email  ramyaashwath@fathermuller.in  
 
Details of Contact Person
Public Query
 
Name  Mrs Thamizharasi N 
Designation  Assistant Professor 
Affiliation  Father Muller College of Nursing 
Address  Father Muller College of Nursing, Obstetrics and Gynaecological Nursing Department, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9481068009  
Fax    
Email  thamizharasi15@fathermuller.in  
 
Source of Monetary or Material Support  
Ms Preetha Sonia Dsouza Father Muller College of Nursing Kankanady Mangaluru taluk Dakshina Kannada district karnataka state India-575002 
 
Primary Sponsor  
Name  Ms Preetha Sonia Dsouza 
Address  Father Muller College of Nursing, Obstetrics and Gynaecological Nursing, 1st MSc Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka India-575002 
Type of Sponsor  Other [Self funded] 
 
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 
Sr Helen Fernandes  Spandana Trust- Social Welfare Unit  Infant Marys Convent, Sisters of Charity,Jeppu, Mangaluru, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA 
8867601060

spandanatrust03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee (FMIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Post Menopausal Women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Yoga Nidra  n this present study researcher would like to investigate the Effectiveness of Yoga Nidra on Stress and Insomnia among postmenopausal women who belong to self-help groups at Mangaluru. A researcher has certified and completed her training in Yoga Nidra. Permission letter has been obtained from the administrator of Spandana Trust Jeppu Mangaluru and Father Muller Ethics Committee has permitted to conduct research study. Postmenopausal women who completed menopause from past twelve months were selected as samples in this study. In this present study researcher used true experimental design. Sample size calculation was done by institutional biostatistician and this present study sample size is 60 experimental group thirty and control group thirty and samples were selected by random sampling method. Investigator obtains consent from the subjects pre test will be be given to assess Stress (Perceived Stress Scale) and Insomnia(Insomnia Severity Index) levels in the experimental group followed by Yoga Nidra guided meditation will be given for every day evening 30 minutes for 30 days, on 30th day post test will be given to assess stress and insomnia level. Investigator obtains consent from the control group subjects, a pre-test will be given to assess stress and insomnia levels followed by a post-test will be given on the 31st day. Results will be analyzed by the investigator. 
Comparator Agent  Yoga Nidra on stress and insomnia among post menopausal women  In this present study researcher would like to investigate the Effectiveness of Yoga Nidra on Stress and Insomnia among postmenopausal women who belong to self-help groups at Mangaluru. A researcher has certified and completed her training in Yoga Nidra. Permission letter has been obtained from the administrator of Spandana Trust Jeppu Mangaluru and Father Muller Ethics Committee has permitted to conduct research study. Postmenopausal women who completed menopause from past twelve months were selected as samples in this study. In this present study researcher used true experimental design. Sample size calculation was done by institutional biostatistician and this present study sample size is 60 experimental group thirty and control group thirty and samples were selected by random sampling method. Investigator obtains consent from the subjects pre test will be be given to assess Stress (Perceived Stress Scale) and Insomnia(Insomnia Severity Index) levels in the experimental group followed by Yoga Nidra guided meditation will be given for every day evening 30 minutes for 30 days, on 30th day post test will be given to assess stress and insomnia level. Investigator obtains consent from the control group subjects, a pre-test will be given to assess stress and insomnia levels followed by a post-test will be given on the 31st day. Results will be analyzed by the investigator. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Women who has experienced menopause for a period of 12 months and belongs to self help group  
 
ExclusionCriteria 
Details  who are practicing yoga and meditation, receiving hormonal therapy, stress and anxiety disorder, history of hypertension and diabetes 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
yoga nidra will reduce the stress and insomnia  yoga nidra will reduce the stress and insomnia after 4 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
yoga nidra will help in reduction of post menopausal symptoms  30 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   03/01/2025 
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 this present study researcher would like to investigate the Effectiveness of Yoga Nidra on Stress and Insomnia among postmenopausal women who belongs to self help groups at Mangaluru. Researcher has certified completed her training in Yoga Nidra. Permission letter has obtained from the administrator of  Spandana  Trust Jeppu  Mangaluru and  Father Muller Ethics Committee has permitted to conduct research study. Postmenopausal women who completed menopause from past twelve months were selected as samples in this study. In   this present study researcher used true experimental design. Sample size calculation was done by institutional biostatistician and this present study sample size is 60 experimental group thirty and control group thirty and samples were selected by random sampling method. Investigator obtains consent from the subjects pre test will be  given to assess Stress (Perceived Stress Scale) and Insomnia(Insomnia Severity Index)  level to experimental group followed by Yoga Nidra guided meditation  will be given for every day evening 30 minutes for 30 days, on 30th day post test will be given to assess stress and insomnia level. Investigator obtains consent from the control group subjects, pre test will be given to assess stress and insomnia level followed by post test will be given on 31st day. Results will be analyzed  by the investigator.

 
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