| CTRI Number |
CTRI/2025/02/081217 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Influence of Positive Psychology on Pain in Fibromyalgia |
|
Scientific Title of Study
|
Relationship between Hope, Optimism, Emotional regulation, and Pain in Fibromyalgia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avani Patel |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education
Bangalore
KARNATAKA
560017
India |
| Phone |
8433741975 |
| Fax |
|
| Email |
avani.mhsblr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeeshma Vijin |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of higher Education
Bangalore
KARNATAKA
560017
India |
| Phone |
8217723829 |
| Fax |
|
| Email |
jeeshma.vijin@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Jeeshma Vijin |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of higher Education
Bangalore
KARNATAKA
560017
India |
| Phone |
8217723829 |
| Fax |
|
| Email |
jeeshma.vijin@manipal.edu |
|
|
Source of Monetary or Material Support
|
| No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal
College of Health Professions, Manipal Academy of Higher Education, Bangalore 560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health
Professions, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Avani Patel |
Manipal Hospital |
Department of Rheumatology, Outpatient Service, Upper Basement, Manipal Hospital,
No. 98 HAL Old Airport road, Kodihalli, 560017
Bangalore
KARNATAKA |
8433741975
avani.mhsblr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M797||Fibromyalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Fibromyalgia |
|
| ExclusionCriteria |
| Details |
1. Individuals with other rheumatoid disorders such as rheumatoid arthritis.
2. Individuals with history of substance use. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
Once at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hope |
Once at baseline |
| Optimism |
Once at baseline |
| Emotional Regulation |
Once at baseline |
|
|
Target Sample Size
|
Total Sample Size="269"
Sample Size from India="269"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="270" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
24/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, and sleep disturbances. Individuals with FM often face challenges in managing chronic pain and its impact on daily life. A study conducted on various samples have shown that high levels of hope and optimism is associated with lesser amount of pain. A meta-analysis done from 83 studies indicate physical health outcomes such as physical symptoms and pain is affected optimism. Higher levels of emotional regulation and optimism related to lower levels of stress, anxiety, depression in 366 health care students. Emotional regulations, anxiety, depression, anger, pain, and disability when studied in population with fibromyalgia indicated greater difficulties in regulating emotions. It is also proven that high hopes are related to lesser fatigue and stress in FM patients. Hope is a positive emotional state characterized by the anticipation and belief that positive outcomes are possible in the future. Optimism is a generalized expectation that good things will happen in the future. It involves a positive outlook on life, with the belief that positive outcomes are more likely than negative ones. The measures of hope, optimism and emotional regulation have not been studied extensively in FM in India. This study aims to find the correlation between hope, optimism, emotional regulation, and pain in FM patients. The hypothesis of this study is that high levels of hope, optimism and emotional regulation is related to lower levels of pain in individuals. Studying hope and optimism can provide insights into how these positive psychological factors contribute to improved coping with pain and better emotional regulation for individuals with fibromyalgia. |