| CTRI Number |
CTRI/2024/11/077108 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Meditation ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Rajyoga Meditation and Physiological Psychological Social parameters of Substance abuse patients |
|
Scientific Title of Study
|
A Randomised Controlled Trial to Determine the Effect of Rajyoga Meditation on Selected Physiological, Psychological and Social Parameters among Patients with Psychoactive substance abuse at Selected Health Care Centers of Punjab |
| Trial Acronym |
Meditation |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANJALI SINGH |
| Designation |
Assistant Professor |
| Affiliation |
Baba Farid University of Health Sciences Faridkot |
| Address |
State Institute of Nursing and Paramedical Sciences Badal
Faridkot
PUNJAB
152116
India |
| Phone |
8968088122 |
| Fax |
|
| Email |
anjalisingh26july@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat Pareek |
| Designation |
Professor cum Principal |
| Affiliation |
Baba Farid University of Health Sciences Faridkot |
| Address |
Saraswati Professional and Higher Education College of Nursing VPO Gharaun Teh Kharar District SAS NAGAR Mohali punjab
Faridkot
PUNJAB
140103
India |
| Phone |
9914583417 |
| Fax |
|
| Email |
pareekbharat10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat Pareek |
| Designation |
Professor cum Principal |
| Affiliation |
Baba Farid University of Health Sciences Faridkot |
| Address |
Saraswati Professional and Higher Education College of Nursing VPO Gharaun Teh Kharar District SAS NAGAR Mohali
Faridkot
PUNJAB
140103
India |
| Phone |
9914583417 |
| Fax |
|
| Email |
pareekbharat10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Civil Hospital District
Bathinda
Civil Hospital District Muktsar |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 |
| Dr Arun Bansal |
Civil Hospital Bathinda |
Department of psychiatry and Deaddiction
Bathinda
PUNJAB |
9876193007
catchthebansal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Civil Hospital Bathinda |
Approved |
| Saraswati Professional and higher Education College of Nursing Gharuan Mohali Punjab |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F191||Other psychoactive substance abuse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rajyoga Meditation Programme (Nonpharmacological intervention ) |
The intervention includes Rajyoga Meditation programme which is nonpharmacological intervention consists of various sessions & meditation module activities.
|
| Comparator Agent |
Standard Treatment |
Existing treatment and activities for substance abuse |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will be willing to participate in the study
Patients who will be taking treatment for psychoactive substance abuse at selected health care centers |
|
| ExclusionCriteria |
| Details |
Patients who will be critically ill
Patients who did not complete at least 70% of the scheduled sessions
Patients with any type of cardiorespiratory disease |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Physiological Psychological and Social Variables pf Substance abuse patients |
2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/12/2024 |
| 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="1"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response (Others) -
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 20-07-2028 and end date provided 20-07-2030?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A Randomised Controlled Trial to Determine the Effect of Rajyoga Meditation on Selected Physiological Psychological and Social Parameters among patients with psychoactive Substance Abuse at selected Health Care Centers of Punjab Objectives To assess the physiological psychological and social functioning among patients with psychoactive substance abuse in experimental and control group To evaluate the relative effectiveness of the Rajyoga meditation module in terms of mean posttest score comparison of selected physiological psychological and social functioning among patients with psychoactive substance abuse in experimental and control group Research hypothesis H1 Substance abuse patients who participate in the Rajyoga Meditation program will have different mean post-test scores on physiological psychological and social functioning than those who did not participate in the intervention at alpha 0.05 for the two-tailed test |