- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07710625
"Turkish Validity and Reliability of the Heat Sensitivity Scale for Individuals With Parkinson's Disease"
21. juli 2026 opdateret af: Nuray Alaca, Acibadem University
Cross-Cultural Adaptation and Psychometric Evaluation of the Turkish Version of the Heat Sensitivity Scale in Individuals With Parkinson's Disease
The aim of this study is to examine the validity and reliability of the Turkish version of the Heat Sensitivity Scale in individuals with Parkinson's disease.
This cross-sectional methodological study will evaluate the psychometric properties of the scale, including internal consistency, test-retest reliability, and construct validity, in order to provide a valid and reliable tool for assessing temperature sensitivity in Turkish-speaking individuals with Parkinson's disease.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Turkey
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Istanbul, Turkey, Tyrkiet (Türkiye), +90
- Rekruttering
- Acibadem University
-
Kontakt:
- Nuray ALACA
- Telefonnummer: 05324251290
- E-mail: nuray.alaca@acibadem.edu.tr
-
-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study population will consist of individuals with clinically diagnosed Parkinson's disease (Hoehn and Yahr stage 1-3), aged between 40 and 85 years, with adequate cognitive function (MMSE ≥ 24).
Participants will be recruited from patients attending the Movement Disorders Outpatient Clinic of the Neurology Department.
The study population represents ambulatory individuals with mild to moderate disease severity suitable for comprehensive biopsychosocial assessment.
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of Parkinson's disease
- Hoehn and Yahr stage 1-3
- Age between 40 and 85 years
- Mini-Mental State Examination score ≥ 24
- Sufficient cognitive and communication ability to complete the assessments
- Attendance at the Movement Disorders Outpatient Clinic of the Neurology Department
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Presence of a major psychiatric disorder, such as major depressive disorder or a psychotic disorder
- Diagnosis of advanced dementia
- Presence of an uncontrolled systemic chronic disease, such as uncontrolled diabetes mellitus or hypertension
- Presence of a severe cardiovascular or respiratory condition
- Presence of an additional orthopedic or neurological condition that may affect assessment performance
- Severe visual or hearing impairment that may interfere with the assessments
- Inability to cooperate adequately during the assessments
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Heat Sensitivity Scale Total Score
Tidsramme: Baseline (at the time of questionnaire administration)
|
Heat sensitivity will be assessed using the Turkish version of the Heat Sensitivity Scale in individuals with Parkinson's disease.
The scale evaluates symptoms related to heat sensitivity and their impact on daily life.
The total score ranges from 29 to 116, with higher scores indicating greater heat sensitivity-related problems and therefore a worse outcome.
Psychometric properties, including internal consistency, test-retest reliability, and construct validity, will be analyzed.
|
Baseline (at the time of questionnaire administration)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Parkinson's Disease Questionnaire-39 (PDQ-39) Total and Subscale Scores
Tidsramme: Baseline (at the time of questionnaire completion)
|
Quality of life will be assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39), a validated self-report measure specific to Parkinson's disease.
The questionnaire consists of 39 items across 8 domains, including mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.
Scores can be transformed to a 0-100 scale, with higher scores indicating worse quality of life.
PDQ-39 scores will be used to evaluate the construct validity of the Turkish version of the Temperature Sensitivity Scale.
|
Baseline (at the time of questionnaire completion)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
25. maj 2026
Primær færdiggørelse (Anslået)
25. december 2026
Studieafslutning (Anslået)
25. maj 2027
Datoer for studieregistrering
Først indsendt
14. juli 2026
Først indsendt, der opfyldte QC-kriterier
14. juli 2026
Først opslået (Faktiske)
17. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-05-220
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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