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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  
Self 
 
Primary Sponsor  
Name  self finanacing 
Address  NA 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
NA  NA 
 
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 endometriosis”.
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
 
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