NCT04802577

Fatigue in Primary Sjögren's Syndrome

The Level of Fatigue and Its Relationship With Disease Activity, Pain, Insomnia, and Psychometric Parameters in Primary Sjögren's Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.

Detailed description

While fatigue is seen with a prevalence of 7-8% in the normal population, it is more prevalent in Primary Sjögren's syndrome (PSS). In the studies conducted so far, the frequency of fatigue was seen at a frequency of over 30% in Primary Sjögren's syndrome. Although fatigue is so common in PSS, there is not enough data about the conditions in which fatigue develops in PSS. Other common conditions in PSS, apart from fatigue, are psychometric disorders such as common pain, depression and anxiety, and sleep disorders. In the studies conducted so far, each situation mentioned is common in PSS and seems to be related to each other. In the literature, there is no data on how many psychometric parameters, pain level, and insomnia affect fatigue and which are independent risk factors in PSS.

Conditions

• Sjogren's Syndrome
• Fatigue
• Pain Syndrome
• Depression
• Anxiety
• Fibromyalgia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FACT-F questionnaire	The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.
DIAGNOSTIC_TEST	Beck Depression Inventory	The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.
DIAGNOSTIC_TEST	Beck Anxiety Inventory	The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.
DIAGNOSTIC_TEST	Insomnia severity index.	The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.
OTHER	ESSPRI	The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants.
OTHER	ESSDAI	Activity scale in which the activity of Sjögren's syndrome is evaluated based on the laboratory and imaging tests of the patients and the examination findings of the evaluator.
OTHER	Pain Detect Questionnaire	The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants.

Timeline

• Start date: 2021-01-04
• Primary completion: 2021-07-30
• Completion: 2021-07-30
• First posted: 2021-03-17
• Last updated: 2021-12-13

Locations

1 site across 1 country: Turkey (Türkiye)