An Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children
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| ClinicalTrials.gov Identifier: NCT03960944 |
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Recruitment Status :
Completed
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psychological Disturbance Anxiety Disorder of Childhood | Other: Yoga | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Psychological Effect of School Based-Yoga on Low-Income School Children: Randomised Controlled Trial |
| Actual Study Start Date : | May 21, 2018 |
| Actual Primary Completion Date : | December 21, 2018 |
| Actual Study Completion Date : | March 12, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Yoga in School Group
30-mins yoga sessions were conducted in schools for 8-weeks
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Other: Yoga
30 Min Yoga session included of Physical posture, Breathing exercise, Yoga games and Relaxation. |
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No Intervention: Control Group
Usual Activities in school
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- Anxiety [ Time Frame: Change from baseline to 8 weeks ]Anxiety score was measured through State and Trait Anxiety Inventory
- Depression [ Time Frame: Changes from baseline to 8 weeks ]Depression Score was measured through Beck Depression Inventory
- Self Esteem [ Time Frame: Changes from baseline to 8 weeks ]Self Esteem was measured through Rosenberg Self-esteem scale
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| Ages Eligible for Study: | 8 Years to 13 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Low income Group
- Parental consent to participate in study
Exclusion Criteria:
- Disabilities
- Substance abuse
- Living outside the school areas
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960944
| India | |
| NMP Medical Research Institute | |
| Mumbai, Maharashtra, India | |
| United Research International | |
| Jaipur, Rajasthan, India | |
| Arsha Vidya Study Centre | |
| Chennai, Tamilnadu, India | |
| Study Chair: | Buddhatmananda Saraswati | Arsha Vidya Study Centre, India | |
| Study Director: | Divya Gaur | United Research International, India | |
| Principal Investigator: | Rajubhai P Odedra | NMP Medical Research Institute, India |
| Responsible Party: | NMP Medical Research Institute |
| ClinicalTrials.gov Identifier: | NCT03960944 |
| Other Study ID Numbers: |
NMP/UNRI |
| First Posted: | May 23, 2019 Key Record Dates |
| Last Update Posted: | May 23, 2019 |
| Last Verified: | May 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Anxiety Disorders Mental Disorders |

