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The Profile of Fatigue and Discomfort - Sicca Symptoms Inventory

Reliability, Validity, and Cross-cultural Adaptation of the Turkish Version of the Profile of Fatigue and Discomfort - Sicca Symptoms Inventory in Sjogren Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04975087
Enrollment
100
Registered
2021-07-23
Start date
2021-10-15
Completion date
2022-12-30
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren's Syndrome

Keywords

sjogren, validity, reliability, fatigue, sicca symptoms

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.

Interventions

OTHERPatients group

Patients will complete the mentioned questionnaires.

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the Profile of Fatigue and Discomfort - Sicca Symptoms Inventory10 minutesIt is scored between 0-7 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactFulden SARİ, doctorate
fuldensari@hotmail.com+90 5069654352
Backup ContactDeran OSKAY, Prof
deranoskay@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026