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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06357793
Other study ID # camsakuraftr
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 15, 2024
Est. completion date December 15, 2024

Study information

Verified date May 2024
Source Basaksehir Çam & Sakura City Hospital
Contact DEMET FERAHMAN, MD
Phone +905364702930
Email demetferahman@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. It is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. The main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity.


Description:

This cross-sectional study will evaluate FM patients and their relatives, who are in paid full- or part time employment at the time of the assessment. The study protocol doesn't require any medical intervention. Fibromyalgia severity will be assessed with the fibromyalgia impact questionnaire (FIQ). Evaluation of patient relatives' work productivity and activities will be made with the Work Productivity and Activity Impairment questionnaire: General Health (WPAI:GH). Analyzes will be completed with a group of healthy controls in the study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 122
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Study Group: Must live together with a patient diagnosed with FM 18-65 years old Must work in a full-time/part-time job Control Group: Must live with a healthy relative 18-65 years old Must work in a full-time/part-time job Exclusion Criteria: Must live alone Not having a full-time/part-time job

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Basaksehir Çam & Sakura City Hospital

References & Publications (3)

Neumann L, Buskila D. Quality of life and physical functioning of relatives of fibromyalgia patients. Semin Arthritis Rheum. 1997 Jun;26(6):834-9. doi: 10.1016/s0049-0172(97)80027-3. — View Citation

Salaffi F, Di Carlo M, Farah S, Mariani C, Fulginei S, Martino GP, Sarzi-Puttini P. A cross-sectional research on female workers examining the loss of productivity caused by mild, moderate and severe fibromyalgia. Clin Exp Rheumatol. 2022 Jun;40(6):1151-1158. doi: 10.55563/clinexprheumatol/hut4ft. Epub 2022 Jun 8. — View Citation

Tutoglu A, Boyaci A, Koca I, Celen E, Korkmaz N. Quality of life, depression, and sexual dysfunction in spouses of female patients with fibromyalgia. Rheumatol Int. 2014 Aug;34(8):1079-84. doi: 10.1007/s00296-014-2944-z. Epub 2014 Jan 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Work Productivity and Activity of Fibromyalgia Patients' Relatives Work Productivity and Activity Impairment questionnaire 1 day
Secondary Quality of life Fibromyalgia Patients' Relatives World Health Organization Quality of Life questionnaire 1 day
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