| CTRI Number |
CTRI/2025/03/082971 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Meditation ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to find out whether practicing mediatation can enhance happiness among nurses |
|
Scientific Title of Study
|
Effect of twin heart meditation on happiness index among nurses |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manju S S |
| Designation |
Professor |
| Affiliation |
Baby Memorial College of Nursing Kozhikode |
| Address |
Professor
Baby Memorial college of Nursing
Green view colony road
Arayadathupalam
Kozhikode
Kozhikode
KERALA
673016
India |
| Phone |
7907708312 |
| Fax |
|
| Email |
manjurupesh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manju S S |
| Designation |
Professor |
| Affiliation |
Baby Memorial College of Nursing Kozhikode |
| Address |
Professor
Baby Memorial college of Nursing
Green view colony road
Arayadathupalam
Kozhikode
Kozhikode
KERALA
673016
India |
| Phone |
7907708312 |
| Fax |
|
| Email |
manjurupesh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manju S S |
| Designation |
Professor |
| Affiliation |
Baby Memorial College of Nursing Kozhikode |
| Address |
Professor
Baby Memorial college of Nursing
Green view colony road
Arayadathupalam
Kozhikode
Kozhikode
KERALA
673016
India |
| Phone |
7907708312 |
| Fax |
|
| Email |
manjurupesh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baby Memorial College of Nursing
Green View Colony Road
Kuthiravattom PO 673016
Kozhikode
Kerala
India |
|
|
Primary Sponsor
|
| Name |
Manju S S |
| Address |
Baby Memorial College of Nursing
Green View Colony Road
Kuthiravattom PO 673016 Kozhikode Kerala India |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Manju S S |
Baby Memorial School of Nursing Thodupuzha Kerala |
Baby Memorial School of Nursing
River View Road Thodupuzha Kerala
Kozhikode
KERALA |
7907708312
manjurupesh21@gmail.com |
| Manju S S |
Baby Memorial College of Nursing Kozhikode |
Baby Memorial College of Nursing
Green View Colony Road
Kuthiravattom PO Kozhikode
Kozhikode
KERALA |
7907708312
manjurupesh21@gmail.com |
| Manju S S |
Baby Memorial Hospital Kannur Kerala |
Baby Memorial Hospital
NH 66 Chala Bypass Nadal Kannur Kerala
Kannur
KERALA |
7907708312
manjurupesh21@gmail.com |
| Manju S S |
Baby Memorial Hospital Kozhikode Kerala |
Baby Memorial Hospital
Indira Gandhi Road
Arayidathupalam
Kozhikode Kerala
Kozhikode
KERALA |
7907708312
manjurupesh21@gmail.com |
| Manju S S |
Baby Memorial School Of Nursing Kozhikode |
Baby Memorial School of Nursing
Green View Colony Road
Kuthiravattom Po Kozhikode
Kozhikode
KERALA |
7907708312
manjurupesh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Baby Memorial Hospital Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with out hypertension glaucoma heart disease. Who are not pregnant Who donot smoke or drink alcohol |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Twin Heart Meditation |
Twin Heart Meditation refers to the guided meditative practice designed to improve physical emotional and spiritual well being. It involves a structured 30 minutes session practiced three times a week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Nurses working in teaching and clinical setting who have
Given consent for participation
Diploma /University degree in nursing and employed in teaching or clinical setting
work experience of at least three months |
|
| ExclusionCriteria |
| Details |
Nurses
Who voluntarily chose to withdraw from the study
Prior experience in the meditation technique in the last six months
With heart disease Glaucoma and hypertension
Who smoke and drink alcohol
Who are pregnant |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Twin Heart Meditation on Happiness index among nurses |
6 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
31/03/2025 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
The study is a randomized control trial to assess the effect of Twin Heart Meditation on Happiness index among nurses .The total 180 registered nurses from seven centers in Kerala India will be randomly selected for the study .The intervention Twin Heart Meditation will be practiced under supervision for three days a week for six weeks .Post test will be conducted after six week of intervention both in experimental and control group . Primary outcome will be effect of Twin Heart meditation on happiness index among nurses. |