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Træthed i Primær Sjögrens syndrom

28. september 2026 opdateret af: Koray Ayar, Bursa Yuksek Ihtisas Training and Research Hospital

Niveauet af træthed og dets forhold til sygdomsaktivitet, smerte, søvnløshed og psykometriske parametre i primært Sjögrens syndrom

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

110

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Volunteers who were followed up with a diagnosis of PSS in the center where the study was conducted and met the inclusion and exclusion criteria.

Beskrivelse

Inclusion Criteria:

  • Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria
  • Healthy hospital staff

Exclusion Criteria:

  • Pregnant women
  • Cancer patients
  • Those with other connective tissue diseases other than PSS
  • Multiple sclerosis patients
  • Chronic obstructive pulmonary disease
  • Those with heart failure and adrenal insufficiency
  • Those with renal failure: GFR <60 ml/min
  • Anemia: Hemoglobin <11 g / dl in women, hemoglobin <12 g / dl in men
  • Hypothyroidism: TSH >5 mu / L
  • Those with electrolyte disturbance

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: CASE_CONTROL
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Primary Sjögren's syndrome

The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria
Diagnostisk test: FACT-F questionnaire

The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.

Diagnostisk test: Beck Depression Inventory

The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.

Diagnostisk test: Beck Anxiety Inventory

The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.

Diagnostisk test: Insomnia severity index.

The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.

Andet: ESSPRI

The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants.

Andet: 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.

Andet: 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.
Healthy Controls

Healthy hospital workers without any chronic disease
Diagnostisk test: FACT-F questionnaire

The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.

Diagnostisk test: Beck Depression Inventory

The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.

Diagnostisk test: Beck Anxiety Inventory

The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.

Diagnostisk test: Insomnia severity index.

The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.

Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
FACIT-F
Tidsramme: day 1

FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE
day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
BDI
Tidsramme: day 1

Beck Depression Inventory
day 1
BAI
Tidsramme: day 1

Beck Anxiety Inventory
day 1
ISS
Tidsramme: day 1

Insomnia Severity Scale
day 1
PDQ
Tidsramme: day 1

Pain Detect Questionnaire
day 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Efterforskere

  • Ledende efterforsker: Koray Ayar, M.D., Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. januar 2021

Primær færdiggørelse (Faktiske)

30. juli 2021

Studieafslutning (Faktiske)

30. juli 2021

Datoer for studieregistrering

Først indsendt

14. marts 2021

Først indsendt, der opfyldte QC-kriterier

14. marts 2021

Først opslået (Faktiske)

17. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011-KAEK-25 2020/12-10

Plan for individuelle deltagerdata (IPD)

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