The Profile of Fatigue and Discomfort - Sicca Symptoms Inventory

NCT04975087 | Unknown

• 1 other identifier: 206
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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%.

Conditions

Primary Sjögren's Syndrome

Keywords

sjogren; validity; reliability; fatigue; sicca symptoms

Outcome Measures

Primary Outcomes (1)

• the Profile of Fatigue and Discomfort - Sicca Symptoms Inventory

  It 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.

  10 minutes

Study Arms (1)

Patients group

Individuals with primary Sjögren's syndrome

Other: Patients group

Interventions

Patients group OTHER

Patients will complete the mentioned questionnaires.

Patients group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with primary Sjögren's syndrome between the ages of 18-85

You may qualify if:

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

You may not qualify if:

• Having cognitive disorders
• Having another rheumatological diseases

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Çankaya, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deran OSKAY, Prof

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Fulden SARİ, doctorate

CONTACT

+90 5069654352; fuldensari@hotmail.com

Deran OSKAY, Prof

CONTACT

deranoskay@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 23, 2021
• Study Start: October 15, 2021
• Primary Completion: June 15, 2022
• Study Completion: December 30, 2022
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

TU (1)