| CTRI Number |
CTRI/2024/11/076597 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the effectiveness of mindfulness based mandala coloring therapy on perceived stress among individuals with cervical cancer |
|
Scientific Title of Study
|
Effectiveness of mindfulness-based mandala coloring therapy on perceived stress among individuals with
cervical cancer: A randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Koj Rija |
| Designation |
First Year M.Sc. Nursing Student |
| Affiliation |
AIIMS Jodhpur |
| Address |
Nursing, Seminar room 3, College of Nursing, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Jodhpur, Rajasthan
Nursing, Seminar room 3, College of Nursing, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7428573229 |
| Fax |
|
| Email |
kojrija16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Aashish Parihar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
College of Nursing, AIIMS Jodhpur, Basni Industrial Area, Rajasthan Jodhpur
College of Nursing, AIIMS Jodhpur, Basni Industrial Area, Rajasthan Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9660314782 |
| Fax |
|
| Email |
parihar1407@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Aashish Parihar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
College of Nursing, AIIMS Jodhpur, Basni Industrial Area, Rajasthan Jodhpur
College of Nursing, AIIMS Jodhpur, Basni Industrial Area, Rajasthan Jodhpur
RAJASTHAN
342005
India |
| Phone |
9660314782 |
| Fax |
|
| Email |
parihar1407@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur, Rajasthan 342005, India |
|
|
Primary Sponsor
|
| Name |
Non-sponsored |
| Address |
Non-sponsored |
| Type of Sponsor |
Other [[]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Non sponsored |
Non sponsored |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Koj Rija |
All India Institute of Medical Sciences Jodhpur |
Department of Radiation oncology 1st floor, Room number 5, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A 1st Phase, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN |
7428573229
kojrija16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F438||Other reactions to severe stress, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness-based mandala coloring therapy |
Day 1
PowerPoint presentation on mindfulness, mandala coloring therapy, and how to use it as a stress-reduction tool.
Video demonstration on how to color mandala
Demonstration on how to color a mandala.
Return demonstration on how to color mandala.
Evening assignments will be distributed to the participants. The design and color of their choice will be used by the participants to color mandalas.
Day 2
Recap of video demonstration.
Mandala coloring activities (Participants will be given a variety of mandala designs as well as bright colored pencils). Participants can color mandalas with colors of their choice.
Evening assignments will be collected and assignments will be given for the day)
Day 3
Mandala coloring activities
A post-test (T1) will be conducted on both the experimental and control group
The participants will be provided with a log book for home assignments before the end of the intervention.
|
| Comparator Agent |
Treatment as usual group |
Participants in the treatment as usual group will receive routine standardized care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Age (18-65 years)
Currently undergoing active cancer treatment (chemotherapy, radiation therapy, or a combination)
Patients who can understand Hindi or English language.
Patients who will be available and willing to participate in the study during data collection.
|
|
| ExclusionCriteria |
| Details |
Critically ill patients who are unable to perform daily activities of living.
Major life events in the past 6 months (Death of loved one, divorce, losing a job etc.)
Severe cognitive impairment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lowered perceived stress |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| functional outcome |
3 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/11/2024 |
| 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="0"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Aim of the study:
To evaluate the effectiveness of Mindfulness-Based
Mandala Coloring Therapy on Perceived Stress among Individuals with Cervical Cancer.
Objective:
- To assess and compare the baseline
level of perceived stress among experimental and waitlist control group
participants living with cervical cancer.
- To compare the effectiveness of
mindfulness-based mandala coloring therapy on perceived stress among
experimental and waitlist control group participants living with cervical
cancer.
- To find the association between
perceived stress among individuals living with cervical cancer and their
selected socio-demographic variables.
Hypothesis:
·
H0 - There will be no
significant difference in perceived stress score among the experiment and waitlist
control group at 0.05 level of significance.
|