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CTRI Number  CTRI/2024/03/064752 [Registered on: 26/03/2024] Trial Registered Prospectively
Last Modified On: 29/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of yoga therapy on sleep deprivation in pregnant mothers 
Scientific Title of Study   Salutogenic Effect of Yoga Therapy on Sleep Deprivation in Antenatal Mothers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vasundhara V R 
Designation  Research Scholar 
Affiliation  Institute of Salutogenesis and Complementary Medicine(ISCM),Sri Balaji Vidyapeeth University 
Address  1st Floor, I- Block, Dept :School of Yoga Therapy(SYT), Institute of Salutogenesis and Complementary Medicine(ISCM), Sri Balaji Vidyapeeth University, Pondicherry
Dept :School of Yoga Therapy(SYT), Institute of Salutogenesis and Complementary Medicine(ISCM), Sri Balaji Vidyapeeth University, Pondicherry
Pondicherry
PONDICHERRY
607402
India 
Phone  9496546042  
Fax    
Email  drvasundharabnys@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ananda Balayogi Bhavanani 
Designation  Director & Professor 
Affiliation  Institute of Salutogenesis and Complementary Medicine(ISCM), Sri Balaji Vidyapeeth University 
Address  1st Floor, I- Block, School of Yoga Therapy(SYT), Institute of Salutogenesis and Complementary Medicine(ISCM), Sri Balaji Vidyapeeth University, Pondicherry
School of Yoga Therapy(SYT), Institute of Salutogenesis and Complementary Medicine(ISCM), Sri Balaji Vidyapeeth University, Pondicherry
Pondicherry
PONDICHERRY
607402
India 
Phone  9842311433  
Fax    
Email  iscm@sbvu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Ananda Balayogi Bhavanani 
Designation  Director & Professor 
Affiliation  Institute of Salutogenesis and Complementary Medicine(ISCM), Sri Balaji Vidyapeeth University 
Address  1st Floor, I- Block, School of Yoga Therapy(SYT), Institute of Salutogenesis and Complementary Medicine(ISCM), Sri Balaji Vidyapeeth University, Pondicherry
School of Yoga Therapy(SYT), Institute of Salutogenesis and Complementary Medicine(ISCM), Sri Balaji Vidyapeeth University, Pondicherry
Pondicherry
PONDICHERRY
607402
India 
Phone  9842311433  
Fax    
Email  iscm@sbvu.ac.in  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed to be University), Pondicherry 607402 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Vasundhara V R  Institute of Salutogenesis and Complementary Medicine (ISCM)  1ST Floor, Block-I, School of Yoga Therapy (SYT), Institute of Salutogenesis and Complementary Medicine(ISCM), Sri Balaji Vidyapeeth University, Pondicherry
Pondicherry
PONDICHERRY 		 9496546042

drvasundharabnys@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Medical College of Research Institute Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  low risk primigravida womens 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Control Group  receives standard medical antenatal care 
Comparator Agent  N/A  N/A 
Intervention  Study Group- Yoga Therapy  The potential participants are antenatal mothers visiting OG OPD, referred by the unit head of Dept of OG, MGMCRI. The yoga intervention group receives bi-weekly yoga classes for 12 weeks, led by a certified yoga instructor specialized in prenatal yoga along with standard medical antenatal care after assesment of Pre data. The post-data will be collected after 3 months (12 weeks) from the subjects. Participants will complete assessments at baseline, 6 weeks, and 12 weeks. Once the data are assessed and analyzed statistically by the statistician, and the results will be interpreted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Gestation age from 22nd weeks.
2. Low-risk primigravida/pregnancy. 
 
ExclusionCriteria 
Details  1. High-risk pregnancy and Infertility cases under treatment, precious pregnancy
2. Multigravida Pregnant women.
3. Those who are known cases of psychiatric disorder, epilepsy, medical and Obstetrics complications. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Effective changes in sleep deprivation symptoms.
2.Effective changes in overall sleep quality.
3.Effective changes of daytime sleepiness on activities of daily living 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in maternal cardiovascular and respiratory changes.
2. Stress level of antenatal mothers
2.Changes in fetal cardiovascular changes 		 12 weeks 
 
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
Modification(s)  		 Phase 1/ Phase 2 
Date of First Enrollment (India)   01/04/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drvasundharabnys@gmail.com].

  6. For how long will this data be available start date provided 26-01-2026 and end date provided 26-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

The methodology for this study will involve recruiting antenatal mothers visiting OG OPD ,MGMCRI and randomly assigning them to yoga intervention group or control group. The yoga intervention group will participate in a structured yoga program biweekly for 12 weeks specifically designed for antenatal women, while the control group will receive standard prenatal care without the yoga intervention.

Data Collection: Data will be collected through a combination of self-reported measures and objective assessments. Participants will be asked to complete questionnaires Pittsburgh sleep quality index (PSQI), The Functional Outcomes of Sleep Questionnaire (FOSQ),  Sense of Coherence (SOS) before and after the intervention. In addition, physiological measures such as, Maternal examination, Metabolic Parameter, Obstetrics scan report (Fetal ultrasound Scan) from Maternal & fetal hospital routine antenatal checkup (from hospital patient case sheet) will be recorded to assess the impact of the yoga intervention. Statistical analysis will be conducted to compare the outcomes between the yoga intervention group and the control group..

Ethical Considerations :This study will adhere to all ethical guidelines and ensure that participants’ confidentiality and well-being are protected. Informed consent will be obtained from all participants, and the study will be approved by the relevant ethics committee.

Conclusion

By investigating the effectiveness of a yoga intervention in antenatal mothers, this study aims to provide valuable insight into the potential benefits of yoga for this population. The findings from this research could have implications for antenatal care and contribute to the development of holistic approaches to support the physical and mental well-being of expectant mothers.

 
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