- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03960944
An Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children
May 21, 2019 updated by: NMP Medical Research Institute
Psychological Effect of School Based-Yoga on Low-Income School Children: Randomised Controlled Trial
Poverty is a common experience for many children and families in developing countries.
Living in a poor or low-income household has been linked to poor health and increased risk for mental health problems than the general population.
Previous studies link psychological well-being with yoga in adolescents and children.
This study investigated the effects of a structured yoga program on psychological well-being in low-income school children.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maharashtra
-
Mumbai, Maharashtra, India
- NMP Medical Research Institute
-
-
Rajasthan
-
Jaipur, Rajasthan, India
- United Research International
-
-
Tamilnadu
-
Chennai, Tamilnadu, India
- Arsha Vidya Study Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 13 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Low income Group
- Parental consent to participate in study
Exclusion Criteria:
- Disabilities
- Substance abuse
- Living outside the school areas
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga in School Group
30-mins yoga sessions were conducted in schools for 8-weeks
|
30 Min Yoga session included of Physical posture, Breathing exercise, Yoga games and Relaxation.
|
|
No Intervention: Control Group
Usual Activities in school
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: Change from baseline to 8 weeks
|
Anxiety score was measured through State and Trait Anxiety Inventory
|
Change from baseline to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: Changes from baseline to 8 weeks
|
Depression Score was measured through Beck Depression Inventory
|
Changes from baseline to 8 weeks
|
|
Self Esteem
Time Frame: Changes from baseline to 8 weeks
|
Self Esteem was measured through Rosenberg Self-esteem scale
|
Changes from baseline to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Divya Gaur, United Research International, India
- Principal Investigator: Rajubhai P Odedra, NMP Medical Research Institute, India
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2018
Primary Completion (Actual)
December 21, 2018
Study Completion (Actual)
March 12, 2019
Study Registration Dates
First Submitted
May 21, 2019
First Submitted That Met QC Criteria
May 21, 2019
First Posted (Actual)
May 23, 2019
Study Record Updates
Last Update Posted (Actual)
May 23, 2019
Last Update Submitted That Met QC Criteria
May 21, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMP/UNRI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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