Stress Related DisorderNCT03308630
Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents
A study testing Yoga based Energy Alignment and Mantra in people with Stress Related Disorder and Musculoskeletal Pain, run by NMP Medical Research Institute at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Related Disorder, Musculoskeletal Pain, Headache
- What is being tested?
- Yoga based Energy Alignment and Mantra
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteIndia
- Study dates
- 28 Jun 2017to 25 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All adolescents enrolled at the participating centers and that agree to sign informed consent.
Who cannot join
- not agreement to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents: Stomach Aches, Musculoskeletal Pains, and Headaches
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.
- Conditions
- Stress Related Disorder, Musculoskeletal Pain, Headache
- Being tested
- Yoga based Energy Alignment and Mantra
- Medical subject headings
- Musculoskeletal Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga based Energy Alignment and MantraBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Energy Alignment and Mantra | Experimental | Not described Receives: Behavioral: Yoga based Energy Alignment and Mantra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported Stress
Stress level on the scale of 1-10 was reported before the intervention and after 2 week of practice
Measured: 2 Weeks
Secondary outcomes (3)
Change in Musculo-skeleton Pain measured on VAS
VAS at the beginning and end of the 2 week of intervention
Measured: 2 weeks
Change in Headache severity on VAS
VAS at the beginning and end of the 2 week of study intervention
Measured: 2 weeks
Change in Stomach pain on VAS
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start28 Jun 2017
- Primary completion30 Jul 2017
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Related DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services, Hong Kong Academy of Yoga Therapy
- Responsible party
- Sponsor
- Investigators
- Naveen Meghwal, Principal investigator, Hong Kong Academy of yoga therapy, Hong KongNeha Sharma, PhD, Study director, Warwick Research ServicesPuneet Sharma, Study chair, NMP Medical Research Institute, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308630
- Sponsor's protocol ID
- NMP/10092
- Status last verified
- Oct 2017
- First submitted
- 8 Oct 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents: Stomach Aches, Musculoskeletal Pains, and Headaches
- ClinicalTrials.gov ID
- NCT03308630
- Acronym / sponsor ID
- NMP/10092
- Conditions
- Stress Related Disorder, Musculoskeletal Pain, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services, Hong Kong Academy of Yoga Therapy
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Energy Alignment and Mantra | Experimental | Behavioral: Yoga based Energy Alignment and Mantra |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All adolescents enrolled at the participating centers and that agree to sign informed consent.
Key exclusion criteria (1 listed)
- not agreement to sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga based Energy Alignment and MantraYoga 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. | Behavioural | Energy Alignment and Mantra |
Primary outcome
Self reported Stress
Time frame: 2 Weeks
Stress level on the scale of 1-10 was reported before the intervention and after 2 week of practice
3 secondary outcomes
Change in Musculo-skeleton Pain measured on VAS
Time frame: 2 weeks
Change in Headache severity on VAS
Time frame: 2 weeks
Change in Stomach pain on VAS
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen Meghwal principal investigator
Hong Kong Academy of yoga therapy, Hong Kong
Neha Sharma, PhD study director
Warwick Research Services
Puneet Sharma study chair
NMP Medical Research Institute, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga based Energy Alignment and Mantra in people with Stress Related Disorder and Musculoskeletal Pain, run by NMP Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self reported Stress (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.