| CTRI Number |
CTRI/2024/04/066110 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [psychotherapy] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Mindful Breathing And Positive Affirmations on Body Image Concerns And Quality of Life among Women with Polycystic Ovary Syndrome |
|
Scientific Title of Study
|
The effect of Mindful Breathing and Positive Affirmations on women with Polycystic Ovarian Syndrome: An Intervention Module |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yukti |
| Designation |
Ph.D. Scholar |
| Affiliation |
SGT University |
| Address |
SGT University Budhera, Gurugram, Haryana. Faculty of Behavioral and Social Sciences, 2nd floor, clinical psychology department
Budhera, Gurugram Haryana. Faculty of Behavioral and Social Sciences, 2nd floor, clinical psychology department
Gurgaon
HARYANA
122505
India |
| Phone |
9810352309 |
| Fax |
|
| Email |
kain.yukti26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhanupriya Rathore |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
Budhera, Gurugram, faculty of Behavioral and Social Sciences, 2nd floor, Clinical Psychology department
Budhera, Gurugram, faculty of behavioral and social sciences, 2nd floor, Clinical Psychology department
Gurgaon
HARYANA
122505
India |
| Phone |
9571650769 |
| Fax |
|
| Email |
bhanupriyaa.rathore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhanupriya Rathore |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
Budhera, Gurugram,
Faculty of Behavioral and social sciences, 2nd floor, Clinical Psychology department
Budhera, Gurugram
Faculty of Behavioral and social sciences, 2nd floor, Clinical Psychology department
Gurgaon
HARYANA
122505
India |
| Phone |
9571650769 |
| Fax |
|
| Email |
bhanupriyaa.rathore@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Yukti |
| Address |
SGT University, India, Budhera, Gurugram, Haryana, 122505 |
| Type of Sponsor |
Other [Self] |
|
|
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 Archana Chaudary |
Jyoti clinic and nursing home |
B-32 East Jyoti Nagar Main Loni Road Shahdara Delhi 110093
East
DELHI |
9312573103
jyotinursinghome32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT University, Faculty of Behavioral and Social Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mindful breathing and positive affirmations |
In this study, the comparator is the control group, consisting of 50 participants who will not receive any intervention targeting mindful breathing and positive affirmations. it is a 6-week intervention |
| Intervention |
Mindful Breathing and positive Affirmations |
Mindful Breathing and Positive Affirmations have been used as an integrative approach to develop the module of the intervention program. The pretest will be conducted in the beginning by administering the WHOQoL-Brief and Body Image Scale (BIS) by which the participants will be selected for this study. The intervention module was developed for Women with PCOS. The 12 sessions include Mindful breathing, body scan, and positive affirmations. it is a 6-week intervention program |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Women clinically diagnosed with Polycystic ovary disorder (PCOS) for at least 1 year
2) Age range: 20-45 years
3)Literate women
4) Both married and unmarried women with Indian nationality
|
|
| ExclusionCriteria |
| Details |
1) Women with a history of severe psychiatric disorder
2) Pregnant women
3) Women living outside Delhi NCR
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body image scale scores and quality of life brief scores |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
overall satisfaction with life
satisfaction with body |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="4" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A total of 100 women with PCOS along with poor quality
of life and higher levels of body image concerns between the age range of 20-45
years will be screened for the study. The women who do not meet the criteria or
decline to participate will be excluded. Further, the pre-assessment will be
done. The assessed individuals will be then categorized into two groups, first
the experimental group and the control group. Consequently, a total of 50 PCOS
patients will be allocated to the experimental group and 50 to the control
group. The experimental group will receive the intervention (mindful breathing
technique and positive affirmations) for 6 weeks consisting of weekly meetings
(twice a week). In the initial sessions, education about the intervention
program will be given followed by mindful breathing and the use of positive
affirmations. Each session will be of half an hour. The individuals will be
instructed to practice mindful breathing in the morning for 15 mins daily and
practice positive affirmations 3-4 times a day. They will also be asked to
maintain a journal to keep the record. Participants will be reminded on a
regular basis through telephone to continue the practice. After a duration of 6
weeks, they will be reassessed to see the effect of the interventions, and then
a follow-up will be taken. |