Clinical trial NCT06357793: Evaluation of Work Productivity and Activities of the Fibromyalgia Patients' Relatives
Official title: Evaluation of Work Productivity and Activities of the Relative Living With a Patient With Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fibromyalgia
Work Productivity
Quality of Life
Pain, Chronic
Keywords: fibromyalgia
work productivity and activity impairment
quality of life
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-10
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The revised 2016 American College of Rheumatology (ACR) FM diagnostic criteria were used to diagnose FM. Our study group participants have to live with FM patients. Also they have to work in a full or part-time job.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Work Productivity and Activity of Fibromyalgia Patients' Relatives
timeFrame: 1 day
Secondary outcomes:
measure: Quality of life Fibromyalgia Patients' Relatives
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.