"Self-Compassion and Self-Efficacy in Parkinson's Disease: Associations With Symptoms, Function, and Quality of Life"
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorAcibadem University
About this trial
The aim of this study is to evaluate the associations of self-compassion and self-efficacy levels with symptom severity, functional status, and quality of life in individuals with Parkinson's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of Parkinson's disease
Hoehn and Yahr stage 1-3
Age 40 to 85 years
Mini-Mental State Examination (MMSE) score ≥24
Disqualifiers
Major depressive disorder or psychotic disorder
Advanced dementia
Uncontrolled chronic systemic disease (e.g., diabetes mellitus or hypertension)
Severe cardiovascular or respiratory disease
Trial population
The study population will consist of individuals diagnosed with Parkinson's disease who are classified as Hoehn and Yahr stage 1-3, aged between 40 and 85 years, and have sufficient cognitive function (MMSE ≥ 24). Participants will be recruited from patients attending the Movement Disorders Outpatient Clinic of the Neurology Department
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Self-Report Questionnaire Assessment
Other interventionThis study does not involve any therapeutic intervention. Participants will complete a set of self-report questionnaires assessing self-compassion, self-efficacy, symptom severity, functional status, and quality of life. Data will be collected in a single session for observational analysis.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Self-Compassion Scale (SCS) Total Score
Self-Compassion Scale (SCS) total score. The Self-Compassion Scale consists of 26 items scored on a 1- to 5-point Likert scale. Total scores range from 1 to 5 (calculated as the mean of all items), with higher scores indicating greater self-compassion (better outcome).
Time frame
Baseline (at the time of questionnaire completion)2
Self-Efficacy for Managing Chronic Disease 6-Item Scale Total Score
Self-Efficacy for Managing Chronic Disease 6-Item Scale total score. The scale consists of 6 items scored from 1 (not at all confident) to 10 (totally confident). The total score is calculated as the mean of the six items, ranging from 1 to 10, with higher scores indicating greater self-efficacy for managing chronic disease (better outcome).
Time frame
Baseline (at the time of questionnaire completion)3
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Unified Parkinson's Disease Rating Scale (UPDRS) total score. The total score ranges from 0 to 199, with higher scores indicating greater Parkinson's disease severity and worse clinical status (worse outcome).
Time frame
Baseline (at the time of questionnaire completion)Secondary outcomes
1
Timed Up and Go (TUG) Test Completion Time in Seconds
Functional mobility will be measured using the Timed Up and Go (TUG) test. The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds. Longer times indicate poorer functional mobility.
Time frame
Baseline (at the time of questionnaire completion)2
Six-Minute Walk Test (6MWT) Distance in Meters
Functional exercise capacity will be measured using the Six-Minute Walk Test (6MWT). The total distance walked in six minutes will be recorded in meters. Greater distances indicate better functional capacity.
Time frame
Baseline (at the time of questionnaire completion)3
Mini-Balance Evaluation Systems Test (Mini-BESTest) Total Score
Dynamic balance will be measured using the Mini-Balance Evaluation Systems Test (Mini-BESTest), a 14-item performance-based assessment. Total scores range from 0 to 28, with higher scores indicating better balance performance.
Time frame
Baseline (at the time of questionnaire completion)4
Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score
Quality of life will be measured using the Parkinson's Disease Questionnaire-39 (PDQ-39), a validated disease-specific instrument. Total scores range from 0 to 100, with higher scores indicating poorer quality of life.
Time frame
Baseline (at the time of questionnaire completion)Sponsors and contacts
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Source ClinicalTrials.gov