Subjective Ageing in Fibromyalgia

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT03966820
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

Subjective age or felt age is the term used for how the person feels; one can feel same, younger or older than their actual age. Feeling younger or feeling older may be associated with depression, anxiety, fatigue, sleep, quality of life or cognitive function.

Detailed Description

In this cross-sectional study, the investigators hypothesized that fibromyalgia patients mostly feel older than their actual age and this felt age may be associated with depression, anxiety, fatigue, sleep, quality of life or cognition. After power analysis, study sample calculated as 262 patients, the present study will use 2016 revised American College of Rheumatology criteria to diagnose fibromyalgia.

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-29
• Study Start: 2019-06-01
• Status Verified: 2020-01
• Primary Completion: 2020-01-27
• Study Completion: 2020-01-27
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

Inclusion Criteria

• Fibromyalgia diagnosis using 2016 revised American College of Rheumatology
• aged >18 years old
• Widespread pain more than 3 months

Exclusion Criteria

• Any disease that can cause depression, anxiety, fatigue, poor sleep quality or poor cognitive function except from fibromyalgia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective age	Four months	The study will ask the patient: " how old do you feel?". Subjective age will calculate as Subjective age extracted from actual age. If the result is positive, the patient feel younger, if visa versa the patient feels older
Anxiety	Four months	The status of anxiety will calculate using Beck Anxiety Inventory. This inventory is a self scored, 21 item questionnaire. Higher scores indicate higher anxiety levels of the patient. The total score is calculated by finding the sum of the 21 items. Each question scored 0 to 3 points. Score of 0-21 = low anxiety,score of 22-35 = moderate anxiety, score of 36 and above = potentially concerning levels of anxiety
Sleep	Four months	The status of sleep quality of the patients will calculate using Pittsburgh Sleep Quality Index. The index is a self- scored 24 item questionnaire and 7 subgroups. Higher scores show bad sleep quality and lower scores indicate good sleep quailty.
Fatigue	Four months	The fatigue levels of the patients will be determined using The Fatigue Severity Scale. This scale self-reported 9 item questionnaire, each question scored between 0-7, total score divided to nine and if the result \<2.8, no fatigue and if \> 6.1, chronic fatigue syndrome diagnosis can be made. Higher score shows higher probability of chronic fatigue syndrome.
Depression	Four months	The status of depression will calculate using Beck Depression Inventory. This inventory is a self scored, 21 item questionnaire. Higher scores indicate higher depression levels of the patient.
Life Quailty	Four months	The quality of life of the patients will be determined using Short-form 36. The self-reported questionnaire includes 11 subscales. Higher scores show poorer quality of life.
Cognitive Function	Four months	The cognition status of the patients will be determined using Mini-mental State Examination. This test includes five subscales, scoreing 0 - 30 points. Lower scores show poorer cognitive function

Trial Locations

Locations (1)

Mehmet Akif Guler; 🇹🇷 İstanbul, İ̇stanbul, Turkey