| 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 |
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Scientific Title of Study
|
EFFECT OF YOGA THERAPY ON PSYCHOLOGICAL VARIABLES AMONG CAREGIVERS OF SPECIAL CHILDREN: A RANDOMISED CONTROL TRIAL |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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Primary Sponsor
|
| Name |
CYTER of Sri Balaji Vidyapeeth |
| Address |
CYTER, Sri Balaji Vidyapeeth University, Pillayarkuppam, POndicherry - 607402 |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Satya Special School |
6, 7, 8 ECR Road Karuvadikuppam, Pondicherry - 605008, India |
|
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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 |
|
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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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of special children suffering from stress, anxiety and depression. |
|
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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.
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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
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| 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
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
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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 |
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Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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|
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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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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