Clinical trial NCT04975087: The Profile of Fatigue and Discomfort - Sicca Symptoms Inventory
Official title: Reliability, Validity, and Cross-cultural Adaptation of the Turkish Version of the Profile of Fatigue and Discomfort - Sicca Symptoms Inventory in Sjogren Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Sjögren's Syndrome
Keywords: sjogren
validity
reliability
fatigue
sicca symptoms
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary Sjögren's syndrome between the ages of 18-85

Brief summary: Primary Sjögren's syndrome (pSS) is a chronic, systemic autoimmune disease characterized by disorders of the lacrimal and salivary glands. The disease can be seen in systemic involvement by affecting any organ. It may result in skin, lung and kidney involvement as well as symptoms such as vasculitis and neuropathy. Patients with PSS often report fatigue as an important symptom to manage. Fatigue, defined as an overwhelming feeling of fatigue, lack of energy, and exhaustion, is associated with poor health and functional impairment.

Fatigue is a common symptom of pSS. This symptom is the most important cause of loss of function in patients. It is thought that as a result of fatigue in pSS, decrease in mental health related to physical activity level and quality of life in patients, sleep problems, depression and loss of ability to work. Several mechanisms have been proposed to explain the occurrence of fatigue among sjogren patients, but its underlying physiological basis has not been adequately defined. Therefore, it is a complex, multifaceted and poorly understood symptom.

In population-based studies, approximately 20% of healthy adults report experiencing fatigue, and this rate rises to 60%-70% among patients with autoimmune disorders. Fatigue is the most common non-exocrine symptom in pSS, and the prevalence of fatigue disability among patients with pSS has been reported to be approximately 70%.

Detailed description: In order to evaluate fatigue in primary Sjögren's syndrome patients, questionnaires such as FACIT Fatigue Scale, Sjögren's Syndrome EULAR Patient Reporting Index, Fatigue Severity Scale, Fatigue Multidimensional Assessment Scale and Short Form-36, which are also used in many disease groups, are used. Although the importance of the effect of fatigue on pSS patients has been demonstrated in studies, most of the fatigue assessment questionnaires used are not pSS specific. For this reason, Bowman et al. They developed the Fatigue and Discomfort Profile - Sikka Symptoms Scale (PROFAD-SSI) to assess multidimensional fatigue in patients with pSS, considering disease symptoms. PROFAD-SSI is scored from 0 to 7 on an 8-point Likert scale. The 19-item scale evaluates patients in 8 different dimensions: somatic fatigue, mental fatigue, arthralgia, vascular dysfunction, oral dryness, ocular dryness, cutaneous and vaginal dryness.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary Sjögren's syndrome
* Patients between the ages of 18-65
* Being literate

Exclusion Criteria:

* Having cognitive disorders
* Having another rheumatological diseases

Primary outcomes:
measure: the Profile of Fatigue and Discomfort - Sicca Symptoms Inventory
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Gazi University
state: Ankara
Study officials:
affiliation: Gazi University
name: Deran OSKAY, Prof
role: STUDY_DIRECTOR
References: