| CTRI Number |
CTRI/2024/10/075018 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Pranic Healing, Meditation on Twin Hearts and Superbrain Yoga] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study on Pranic Healing Techniques for PUC repeaters to overcome academic challenges |
|
Scientific Title of Study
|
Effectiveness of Pranic Healing on Increasing Resilience and Wellbeing Among Pre-University Students Facing Academic Setbacks: A Pilot Randomized Waitlist Single Blinded Multigroup Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinu V |
| Designation |
Research Associate |
| Affiliation |
World Pranic Healing Foundation, India-Research Centre, |
| Address |
Research Department
CH 44, First Floor, 4th Main, Saraswathipuram, Mysuru.
Mysore
KARNATAKA
570009
India |
| Phone |
08212340673 |
| Fax |
|
| Email |
vinuboss23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lancy Dsouza |
| Designation |
PROFESSOR |
| Affiliation |
Maharaja Collage, University of Mysore |
| Address |
Department of Psychology, Jhansi Rani Lakshmi Bai Road, Medar Block, Yadavagiri, Mysuru
Mysore
KARNATAKA
570005
India |
| Phone |
9986332616 |
| Fax |
|
| Email |
lancyd@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srikanth Jois |
| Designation |
Head of Research |
| Affiliation |
World Pranic Healing Foundation, India - Research Centre |
| Address |
Research Department 44, 4 main 1 cross Saraswathipuram Mysuru
Mysore
KARNATAKA
570009
India |
| Phone |
9901502828 |
| Fax |
|
| Email |
srikanth@pranichealing.co.in |
|
|
Source of Monetary or Material Support
|
| World Pranic Healing Foundation, India. Darsons, First Floor No 12, Hospital Road, Shivajinagar, Bengaluru 560001 |
|
|
Primary Sponsor
|
| Name |
World Pranic Healing Foundation, India - Research Centre. |
| Address |
44, 4th Main Saraswathipuram, Mysuru |
| Type of Sponsor |
Other [Trust ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vinu V |
World Pranic Healing Foundation, India |
Pranic Healing Room, Research Centre, 44, 4 main, 1 cross Saraswathipuram Mysuru
Mysore
KARNATAKA |
08212340673
vinuboss23@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, World Pranic Healing Foundation, India |
Approved |
| Institution Ethics Committee, World Pranic Heling Foundation, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Students with Academic Setbacks under distress and with common mental health issues (mild to moderate) – DSM V- TR (F43.23, F32.0, F32.9, F41.1, F41.9, F40.10) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention 1 |
Pranic Healing combined with Super Brain Yoga for five weeks. |
| Intervention |
Intervention 2 |
Meditation on Twin Hearts combined with Superbrain Yoga for five weeks. |
| Comparator Agent |
Waitlist Control |
Participants will receive no intervention for the initial five-week period. After five weeks, they will be provided with one of the two interventions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
Male and female students preparing to reappear for the exam, Students who have GHQ-12 scores of 3 to 7 during screening, Age: 18 to 22, Participants who have previous academic records of failure in 12th or PUC, willing to sign the informed Consent. |
|
| ExclusionCriteria |
| Details |
Students with severe mental health issues, who have difficulties in following instructions, who score less than 15% of the total score in their academics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Enhancement of Coping with failure using School Failure Coping scale, Self-Compassion using Self compassion Scale (SCS), Grit using Grit scale
2. Improvement for students with common mental disorders using General Health Questionnaire 12(GHQ-12)
Increase in Salivary oxytocin levels
|
0 and 5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Temperature variation using Thermometer |
First session (0, 10 minutes and after 30 min), Final session (0, 10 minutes and after 30 min) |
| Qualitative Enquiry |
2nd week, 3rd and 5th week |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [research@pranichealing.co.in].
- For how long will this data be available start date provided 24-11-2024 and end date provided 24-11-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This pilot study aims to explore the potential of Pranic Healing techniques, PH along with Super Brain Yoga (SBY) and Meditation on Twin Hearts (MTH) along with SBY, as complementary therapies to enhance resilience and well-being in students who have faced academic failure. The rationale for this study is grounded in the effects of these techniques on mental health and academic performance, which were enhanced in previous studies. Pranic Healing, which integrates energy healing mindfulness and compassion, has shown effectiveness in reducing stress, improving sleep, and enhancing psychological well-being. Combining Pranic Healing with SBY, which is designed to stimulate brain function, may offer additional benefits in helping students cope with academic challenges. This approach addresses the immediate effects of academic failure and builds resilience and coping skills that can support students in their ongoing educational journey. |