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CTRI Number  CTRI/2019/12/022508 [Registered on: 23/12/2019] Trial Registered Prospectively
Last Modified On: 19/12/2019
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 THE BURDENS FACED BY THE CAREGIVERS OF SPECIAL CHILDREN 
Scientific Title of Study   EFFECT OF YOGA THERAPY ON PSYCHOLOGICAL VARIABLES AMONG CAREGIVERS OF SPECIAL CHILDREN: A RANDOMISED CONTROL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Felix Philip 
Designation  PhD Scholar  
Affiliation  CYTER, SBV 
Address  CYTER I Block 1st Floor MGMCRI Campus Sri Balaji Vidyapeeth Pilliyarkuppam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  7200092678  
Fax    
Email  priyaphilip12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ananda Balayogi Bhavanani  
Designation  Professor and Director 
Affiliation  CYTER, SBV 
Address  CYTER I Block 1st Floor MGMCRI Campus Sri Balaji Vidyapeeth Pilliyarkuppam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9842311433  
Fax    
Email  yoga@mgmcri.ac.in  
 
Details of Contact Person
Public Query
 
Name  Ananda Balayogi Bhavanani  
Designation  Professor and Director 
Affiliation  CYTER, SBV 
Address  CYTER I Block 1st Floor MGMCRI Campus Sri Balaji Vidyapeeth Pilliyarkuppam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9842311433  
Fax    
Email  yoga@mgmcri.ac.in  
 
Source of Monetary or Material Support  
CYTER, Sri Balaji Vidyapeeth, MGMCRI, Pondy Cuddalore Main Road, Pilliyarkuppam, Puducherry - 607402  
Priya Felix Philip, CYTER, "I" Block, MGMC&RI Hospital, Pillayarkuppam, Puducherry 607403  
 
Primary Sponsor  
Name  CYTER of Sri Balaji Vidyapeeth  
Address  CYTER, Sri Balaji Vidyapeeth University, Pillayarkuppam, POndicherry - 607402  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Satya Special School  6, 7, 8 ECR Road Karuvadikuppam, Pondicherry - 605008, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priya Felix Philip  Satya Special School  1st Floor, Common Hall, 6, 7, 8 ECR Road Karuvadikuppam, Pondicherry - 605008, India
Pondicherry
PONDICHERRY 
7200092678

priyaphilip12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Human Ethics Committee   Approved 
Satya Special Shool  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers of special children suffering from stress, anxiety and depression. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  They will follow their usual day to day routine without yoga intervention 
Intervention  Yoga Therapy  Validated Yoga Therapy protocol will be administered to the subjects in the experimental group. Supervised classes will be conducted once a week for 60 mins/session. Participants will be motivated to practice at home and maintain a diary that will be used to evaluate compliance and for correlation analysis if possible at the end of the study. Mid-test analyses of all parameters will be done at 3 months and Post-test analyses at end of 6-month study period to assess effects of yoga therapy.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Care givers who are identified as the primary informal caregiver
2. Caregivers within Pondicherry and Tamilnadu.
3. Caregivers of both genders.
4. Caregivers willing to participate with the informed consent form.
5. Caregivers with children below the age of 18 with special needs

 
 
ExclusionCriteria 
Details  1. Caregivers who have had any surgery and are physically unable to take part in the yoga session.
2. Caregivers who are not blood relatives of the child.
3. Caregivers who are pregnant or lactating.
4. Fathers who are alcoholics
5. Caregivers with known case of psychotic disorders
6. Caregivers under medication for psychotic disorders
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of yoga therapy on caregivers burden by using an appropriate scale.
b. To measure the quality of life of caregivers of children with special needs.
c. To evaluate the effect of yoga therapy on depression , anxiety and quality of sleep in caregivers.
 
Assessment will be done at
1. baseline
2. 3 months and
3. 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
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)   23/12/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction:

Caregivers of children with special needs are usually on a life time journey that maybe both financially and emotionally challenging. They may experience countless number of emotions on diagnosis including denial, loss, grief and anger. It is natural to be worried about the child and his/her future and to feel frustrated and helpless at times. A single parent caregiver will have other challenges in addition to those of a common caregiver. Most often their entire lives revolve around care giving that they forget to live their own life. In some situations the siblings become one of the caregivers, which may affect their education, career and their future. Caregivers may be affected by one or more of the following : depression and anxiety, weak immune system, obesity, higher risk for chronic diseases and problems with short-term memory or paying attention. The frequency of reporting symptoms of stress is more by caregivers than non caregivers. Yoga enhances the union of the body, mind and spirit. It empowers the individual and it helps the individual to connect to their own inner resources. The yoga practices will include jathis, asanas, Pranayama and relaxation. Many studies have shown that practice of yoga as a therapy can act in a somatopsychic way to reduce stress, the intensity of the disorder, increase immunity, strengthen the body and the mind, overall increase the feel good aspect of oneself and an improvement in their quality of life.

 

Aims and Objectives:

1.Aim: To study the effect of yoga therapy on psychological variables among care givers of  special children.

2. Objectives

a.       To evaluate the effect of yoga therapy on caregivers burden by using an appropriate scale

b.      To measure the quality of life of caregivers of special children

c.       To evaluate the effect of yoga therapy on depression, anxiety and quality of sleep in caregivers.

 

Subjects and Methods:

The present study will be conducted among caregivers whose children are students of Satya Special School, a school for children with special needs. The participants will be enrolled into the study based on the inclusion and exclusion criteria. They will be further divided into control and experimental group using stratified randomisation and by using zelen’s design subject group change will be done. Supervised Yoga sessions will be administered once a week for 6 months for the participants in the experimental group.

The Sample size of 61 per group was arrived at using sample size calculator. Adding dropout rate at 10%, sample size would be 68 for each group, 

i.e, a total sample size of 136.

 

Work Plan :

  • 136 participants will be recruited after obtaining the informed consent form.
  • Randomization of the subjects will be done into

          Group A - 68 subjects (Experimental group - Yoga Therapy for 6  months)

          Group B - 68 subjects (Control group - they will be following their usual routine)


  • Pre test analysis will be conducted on the psychological parameters using the following scales :

                   Caregiver Burden Scale

                   WHO QOL BREF

                   DASS 21 - Depression, Anxiety, Stress Scale

                   Pittsburgh Sleep Quality Index

             

  • Yoga therapy according to the protocol will be administered to the participants of the experimental group.
  • The duration of a yoga session will be around 45minutes.
  • The participants will be motivated to practice by themselves at home and also to maintain a diary that will be used to evaluate compliance.
  • A mid test analysis will be done for all the participants after 3 months on all the parameters to assess the effects of yoga therapy.
  • Post test analysis will be done at end of 6 months on all the parameters to assess the effects of yoga therapy.
  • Data analysis will be done.
  • Changes in all parameters will be correlated with compliance to yoga therapy and will be assessed.
  • Preparation of final report for publication.
  • After the study period, yoga therapy will be offered to the participants of the control group who are interested.

 

 

 

 


 
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