Back to resultsImmediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents
Primary Purpose
Stress Related Disorder, Musculoskeletal Pain, Headache
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Yoga based Energy Alignment and Mantra
Sponsored by
About this trial
This is an interventional other trial for Stress Related Disorder
Eligibility Criteria
Inclusion Criteria:
- All adolescents enrolled at the participating centers and that agree to sign informed consent.
Exclusion Criteria:
- not agreement to sign the informed consent
Sites / Locations
- NMP Medical Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Energy Alignment and Mantra
Arm Description
Outcomes
Primary Outcome Measures
Self reported Stress
Stress level on the scale of 1-10 was reported before the intervention and after 2 week of practice
Secondary Outcome Measures
Change in Musculo-skeleton Pain measured on VAS
VAS at the beginning and end of the 2 week of intervention
Change in Headache severity on VAS
VAS at the beginning and end of the 2 week of study intervention
Change in Stomach pain on VAS
Full Information
NCT ID
NCT03308630
First Posted
October 8, 2017
Last Updated
October 8, 2017
Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services, Hong Kong Academy of Yoga Therapy
1. Study Identification
Unique Protocol Identification Number
NCT03308630
Brief Title
Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents
Official Title
Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents: Stomach Aches, Musculoskeletal Pains, and Headaches
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
August 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services, Hong Kong Academy of Yoga Therapy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Related Disorder, Musculoskeletal Pain, Headache
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Energy Alignment and Mantra
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Yoga based Energy Alignment and Mantra
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self reported Stress
Description
Stress level on the scale of 1-10 was reported before the intervention and after 2 week of practice
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Change in Musculo-skeleton Pain measured on VAS
Description
VAS at the beginning and end of the 2 week of intervention
Time Frame
2 weeks
Title
Change in Headache severity on VAS
Description
VAS at the beginning and end of the 2 week of study intervention
Time Frame
2 weeks
Title
Change in Stomach pain on VAS
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All adolescents enrolled at the participating centers and that agree to sign informed consent.
Exclusion Criteria:
not agreement to sign the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naveen Meghwal
Organizational Affiliation
Hong Kong Academy of yoga therapy, Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Warwick Research Services
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Puneet Sharma
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Study Chair
Facility Information:
Facility Name
NMP Medical Research Institute
City
Bikaner
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents
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