| CTRI Number |
CTRI/2024/11/076601 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
31/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Pelvic Floor Muscle Training on Pain, Mental Health, and Quality of Life in Women with Polycystic Ovary Syndrome. |
|
Scientific Title of Study
|
Effect of Pelvic Floor Muscles Training on pain,Psychological status and Quality of Life of Polycystic Ovarian Syndrome patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya Mahto |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, Galgotias University, Plot no 2 Sector 17A, Yamuna Expressway, Greater Noida, Gautam Buddh Nagar
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9289497252 |
| Fax |
|
| Email |
Priya.mahto@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Khushboo Hamraz |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Plot no 2 Sector 17A, Yamuna Expressway, Greater Noida, Gautam Buddh Nagar
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8810222121 |
| Fax |
|
| Email |
khushboohamraz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Mahto |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, Galgotias University, Plot no 2 Sector 17A, Yamuna Expressway, Greater Noida, Gautam Buddh Nagar
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9289497252 |
| Fax |
|
| Email |
Priya.mahto@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Research and Developmental cell, Galgotias University, plot no 2 sector 17A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India 203201 |
|
|
Primary Sponsor
|
| Name |
GALGOTIAS UNIVERSITY |
| Address |
Plot no 2 sector 17A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 |
| NA |
Galgotias University |
Department of Physiotherapy, Galgotias University, plot no 2 sector 17A Yamuna Expressway Greater Noida, Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9289497252
Priya.mahto@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N832||Other and unspecified ovarian cysts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kegel Exercise
Bridge Exercises
Squats |
3 times per week for 8 week |
| Intervention |
Pelvic Floor Muscle Training |
3 times per week for 8 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Subject with age 18- 35
2.Female with PCOS
3.Subject willing to participate |
|
| ExclusionCriteria |
| Details |
1. Subject with recent surgery
2. Subject with musculoskeletal disorder
3. Subject with neurological disorder
4. Subject with cardiovascular disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Polycystic Ovary Syndrome Quality of Life Scale
Numeric Pain Rating Scale |
1st week and 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depression Anxiety Stress Scale |
1st week and 8th week |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
22/11/2024 |
| 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="0"
Months="4"
Days="0" |
|
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
|
Pelvic Floor Muscle Training (PFMT) and its impact on women with Polycystic Ovarian Syndrome (PCOS) are the subjects of this study. Infertility, discomfort, and mental health problems are some of the symptoms of PCOS, a prevalent condition. The objective is to determine whether PFMT can assist in lowering pain, enhancing psychological health, and improving these patients’ quality of life. Over the course of eight weeks, 80 women are divided into two groups and given either regular workouts or PFMT. The outcomes are examined for changes in pain and mental health.
Methodology: Type of Study: Experimental Sample: 80 women, aged 18-35, diagnosed with PCOS. Study Groups: Divided into two groups: one received conventional exercises and PFMT, the other only conventional exercises. Variables: Independent variables include age, BMI, height, and weight, while dependent variables relate to PCOS symptoms. Intervention: The PFMT protocol involved daily exercises with a duration of 45 minutes, practiced 2-3 times per week over 8 weeks. Data Analysis: Pre- and post-intervention data compared using SPSS software. |