Evaluation of Work Productivity and Activities of the Fibromyalgia Patients' Relatives

Quality of Life Clinical Trial

Official title:

Evaluation of Work Productivity and Activities of the Relative Living With a Patient With Fibromyalgia Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357793
• Other study ID #: camsakuraftr
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes
• Pain, Chronic
• Quality of Life
• Work Productivity

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