NCT03308630

Brief Summary

Psychiatrists have expressed concern at the emergence of education as a serious source of stress for school-going children - causing high incidence of deaths by suicide. Many adolescents in India are referred to hospital psychiatric units for school-related distress - exhibiting symptoms of depression, high anxiety, frequent school refusal, phobia, physical complaints, irritability, weeping spells, and decreased interest in school work. Previous studies have found significant anxiety, distress, depression, worn outs and severe impact of psychological factors on the performances of dental, engineering and medical student. But students preparing for competitive exams have not been studied yet. Current study reports the scientific evidence of immediate effect of yoga based techniques combined with music and Vedic chants on adolescents preparing for competitive exams.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

October 8, 2017

Last Update Submit

October 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self reported Stress

    Stress level on the scale of 1-10 was reported before the intervention and after 2 week of practice

    2 Weeks

Secondary Outcomes (3)

  • Change in Musculo-skeleton Pain measured on VAS

    2 weeks

  • Change in Headache severity on VAS

    2 weeks

  • Change in Stomach pain on VAS

    2 weeks

Study Arms (1)

Energy Alignment and Mantra

EXPERIMENTAL
Behavioral: Yoga based Energy Alignment and Mantra

Interventions

Yoga intervention was based on the concept that there is not just a physical body, but a "subtle energy" body can be bound with residue of stress, unprocessed emotions, and excess mental energy. Using Yoga based practices combined with Mantra chants, Music and energy alignments poses, stress induced pain can be alleviated.

Energy Alignment and Mantra

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All adolescents enrolled at the participating centers and that agree to sign informed consent.

You may not qualify if:

  • not agreement to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP Medical Research Institute

Bikaner, Rajasthan, India

Location

MeSH Terms

Conditions

Musculoskeletal PainHeadache

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Naveen Meghwal

    Hong Kong Academy of yoga therapy, Hong Kong

    PRINCIPAL INVESTIGATOR
  • Neha Sharma, PhD

    Warwick Research Services

    STUDY DIRECTOR
  • Puneet Sharma

    NMP Medical Research Institute, India

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2017

First Posted

October 12, 2017

Study Start

June 28, 2017

Primary Completion

July 30, 2017

Study Completion

August 25, 2017

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations