CTRI Number |
CTRI/2017/12/010923 [Registered on: 20/12/2017] Trial Registered Prospectively |
Last Modified On: |
08/04/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Yoga in the management of pain and related stress on
women with Endometriosis
|
Scientific Title of Study
|
Efficacy of yoga in the management of pain and related stress on Endometriosis |
Trial Acronym |
RACE |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Maria Pais |
Designation |
Asst. Professor -Senior Scale |
Affiliation |
Manipal College of Nursing, Manipal. |
Address |
Manipal College of Nursing, Manipal University. Manipal
Manipal College of Nursing, Manipal University. Manipal
Udupi KARNATAKA 576104 India |
Phone |
09880873560 |
Fax |
0820-4293982 |
Email |
mariapuso@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Maria Pais |
Designation |
Asst. Professor -Senior Scale |
Affiliation |
Manipal College of Nursing, Manipal. |
Address |
Manipal College of Nursing, Manipal University. Manipal
Manipal College of Nursing, Manipal University. Manipal
Udupi KARNATAKA 576104 India |
Phone |
09880873560 |
Fax |
0820-4293982 |
Email |
mariapuso@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Muralidhar V Pai |
Designation |
Professor |
Affiliation |
K.H Manipal. |
Address |
HoD, OBG Department, K.H Manipal. HoD, OBG Department, K.H Manipal. Udupi KARNATAKA 576104 India |
Phone |
8904839128 |
Fax |
0820-4293982 |
Email |
mvpai@manipal.edu |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
self finanacing |
Address |
NA |
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 |
Maria Pais |
Kasturbha Hospital, Manipal |
Obstetric and Gynecology Department. Udupi KARNATAKA |
9880873560 08202922576 mariapuso@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kasturba Hospital Manipal, Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Women diagnosed with endometriosis., |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Control group |
The control group receiving standard pharmacological therapy only. |
Comparator Agent |
standard care |
The control group receiving standard pharmacological therapy only. |
Intervention |
Yoga therapy |
The study adopts Randomized Control Trial (RCT) design with an intervention group receiving standard pharmacological therapy as advised by the treating gynecologist and yoga therapy for six months. The control group receiving standard pharmacological therapy only. The RCT design is characterized by properties like manipulation, control and randomization. The block randomization will be used for the present study. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
Women who diagnosed with endometriosis by ultrasound/laparoscopy.
Women who are not seeking infertility management
Women who are able to read and write Kannada
Women who are willing to practice yoga at home.
|
|
ExclusionCriteria |
Details |
Women with psychiatric illness like psychotic and depression.
Women with physical abnormality like pelvic inflammatory disease.
Previous exposure to Yoga therapy.
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Pain and stress level |
At the time of enrollment and at 3rd month. |
|
Secondary Outcome
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
Phase 1 |
Date of First Enrollment (India)
|
20/12/2017 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Suspended |
Recruitment Status of Trial (India) |
Suspended |
Publication Details
|
Not yet |
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 determine the effectiveness of yoga therapy in the management of pain and related stress in women diagnosed to have endometriosisâ€. 3. Objectives (hypotheses if applicable) : 1. To assess the pain experienced by women diagnosed with endometriosis as measured by visual analogic scale. 2. To assess the stress experienced by women diagnosed with endometriosis as measured by stress rating scale. 3. To assess the effectiveness of yoga therapy on pain and stress experienced by women diagnosed with endometriosis. Hypotheses: H1: There will be significant difference in the pretest and posttest mean pain scores between experimental and control group. H2: There will be significant difference in the pretest and posttest mean stress scores between experimental and control group. 4. Justification for study (whether of national significance with rationale): Endometriosis is a painful, chronic disease that affects at least 6.3 million women and girls in the U.S., 1 million in Canada, and millions more worldwide. It occurs when tissue like that which lines the uterus (tissue called the endometrium) is found outside the uterus -- usually in the abdomen on the ovaries, fallopian tubes, and ligaments that support the uterus; the area between the vagina and rectum; the outer surface of the uterus; and the lining of the pelvic cavity. A recent study published in Journal showed that yoga therapy helped many endometriosis patients with chronic pelvic pain and had positive effect on their quality of life. There is no cure for endometriosis or its symptoms. Not even surgical intervention has been proven to be completely effective. The modern alternative and complimentary methods are shown some beneficial effect on several chronic disease. Mind-body practices such as yoga therapy may improve the immune system, control stress and pain. The Tertiary care Hospital in Manipal where endometriosis patients are coming for regular treatment, by assessing the pain and stress level, how much the women will suffer with endometriosis. Providing additional complimentary therapy it may reduce the pain and stress level and improves the life style, which may further allow us to give recommendations for provision of better care. This study also provides an excellent platform for the extensive learning of endometriosis and Efficacy of yoga in the management of pain and related stress on women with Endometriosis |