| CTRI Number |
CTRI/2025/11/096890 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out the prevalence of muscle pain, fatigue and sleep quality among college girls with and without PCOS |
|
Scientific Title of Study
|
Musculoskeletal pain, Fatigue and sleep quality among college students with and without polycystic ovarian syndrome(PCOS) : A case control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Christy sopna s |
| Designation |
PhD Scholar , Assistant Professor in physiotherapy |
| Affiliation |
college of allied health sciences East coast institute of medical sciences |
| Address |
Room No.1(staff room), Third floor, Department of physiotherapy, College of allied health sciences, East coast institute of medical sciences,No.1, paris nagar, moolakulam, puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
7339626450 |
| Fax |
|
| Email |
christysopna.jesus@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V RAJALAXMI |
| Designation |
vice principal & professor |
| Affiliation |
ACS medical college and hospital Dr. M.G.R Educational and research institute |
| Address |
Room no.3, ground floor, Faculty of physiotherapy, A.C.S medical college & hospital, velappanchavadi, chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9176123939 |
| Fax |
|
| Email |
rajalaxmiphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V RAJALAXMI |
| Designation |
vice principal & professor |
| Affiliation |
ACS medical college and hospital Dr. M.G.R Educational and research institute |
| Address |
Room no.3, ground floor, Faculty of physiotherapy, A.C.S medical college & hospital, velappanchavadi, chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9176123939 |
| Fax |
|
| Email |
rajalaxmiphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Allied health sciences, East coast institute of medical sciences
College of Nursing, East coast institute of medical sciences
No.1, paris nagar, moolakulam, puducherry 605010, India. |
|
|
Primary Sponsor
|
| Name |
Christy sopna S |
| Address |
college of allied health sciences, East coast institute of medical sciences.
No.1, paris nagar, moolakulam, puducherry 605010, India. |
| Type of Sponsor |
Other [self financed ] |
|
|
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 S christy sopna |
college of Nursing,East coast institute of medical sciences |
Fourth floor, Room No.9 (Physiotherapy lab),Department of physiotherapy, no. 1 paris nagar, moolakulam, puducherry-605010
Pondicherry
PONDICHERRY |
7339626450
christysopna.jesus@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PCOS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1. College girls aged between 18-25
2. BMI 18-35 Kg/m2
3. Unmarried girls
4. Diagnosed cases of PCOS based on Rotterdam criteria
5. College girls who are willing to participate
6. Subjects who are willing to provide informed consent.
7. Sufficient English/tamil language to understand and complete the outcome tool
|
|
| ExclusionCriteria |
| Details |
1. Other causes of menstrual disturbances, hyperandrogenism, adrenal diseases and pregnancy
2. Known cardiovascular problems, uncontrolled hypertension or hypotension
3. Presence of neurological disease, orthopaedic illness, cardiopulmonary disease and musculoskeletal injuries
4. Known psychiatric illness, Physical ailments & musculoskeletal injuries
5. Inability to cooperate
6. Any other hormonal imbalances
7. Married girls with PCOS
8. concurrent treatments (insulin sensitizers as metformin and pioglitazone)
9. adrenal hyperplasia, thyroid dysfunction, hyperprolactinaemia, chronic cough (bronchitis) during the last three months, gastrointestinal disease, asthma, diabetes, urinary tract infection
10. College girls taking any anti-allergic or pain medications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Modified Nordic musculoskeletal questionnaire – To measure the musculoskeletal pain
• Fatigue severity scale (FSS) – To measure fatigue level
• Pittsburg sleep quality Index (PSQI) – To measure the quality of sleep
|
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
17/11/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
1. INTRODUCTION: Polycystic Ovarian Syndrome (PCOS) is a prevalent endocrine disorder affecting 6–10% of women of reproductive age globally, with even higher prevalence in South Asian countries like India While PCOS is widely studied for its metabolic and reproductive implications, its impact on musculoskeletal health, fatigue, and sleep quality is underexplored. Emerging evidence suggests that PCOS is associated with chronic low-grade inflammation, insulin resistance, and obesity - factors contributing to musculoskeletal pain and fatigue This study aims to compare the prevalence and severity of musculoskeletal pain, fatigue, and sleep quality in college-aged females with and without PCOS Primary objectives: · To compare the prevalence of musculoskeletal pain, fatigue, and quality of sleep among college girls with PCOS and without PCOS Secondary objectives · To analyse the association between musculoskeletal pain and fatigue between the girls with PCOS and the control group without PCOS · To analyse the association between musculoskeletal pain and quality of sleep between the girls with PCOS and control group without PCOS · To analyse the association between fatigue and quality of sleep between the girls with PCOS and control group without PCOS · To assess the correlation between musculoskeletal pain , fatigue and sleep quality among girls with PCOS and without PCOS |