- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07488351
"Self-Compassion and Self-Efficacy in Parkinson's Disease: Associations With Symptoms, Function, and Quality of Life"
July 14, 2026 updated by: Nuray Alaca, Acibadem University
"Associations of Self-Compassion and Self-Efficacy With Symptom Severity, Functional Status, and Quality of Life in Individuals With Parkinson's Disease: A Cross-Sectional Study"
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nuray ALACA
- Phone Number: 05324251290
- Email: nuray.alaca@acibadem.edu.tr
Study Locations
-
-
Turkey
-
Istanbul, Turkey, Turkey (Türkiye), +90
- Recruiting
- Acibadem University
-
Contact:
- Nuray ALACA
- Phone Number: 05324251290
- Email: nuray.alaca@acibadem.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study 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
Description
Inclusion Criteria:
- Clinical diagnosis of Parkinson's disease
- Hoehn and Yahr stage 1-3
- Age 40 to 85 years
- Mini-Mental State Examination (MMSE) score ≥24
- Sufficient cognitive function to communicate and complete study assessments
- Attending the Movement Disorders Outpatient Clinic, Department of Neurology
- Able and willing to provide written informed consent
Exclusion Criteria:
- Major depressive disorder or psychotic disorder
- Advanced dementia
- Uncontrolled chronic systemic disease (e.g., diabetes mellitus or hypertension)
- Severe cardiovascular or respiratory disease
- Additional neurological or orthopedic conditions that may affect assessment performance
- Severe visual or hearing impairment that could interfere with study assessments
- Inability to cooperate with the physiotherapist during study assessments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Compassion Scale (SCS) Total Score
Time Frame: Baseline (at the time of questionnaire completion)
|
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).
|
Baseline (at the time of questionnaire completion)
|
|
Self-Efficacy for Managing Chronic Disease 6-Item Scale Total Score
Time Frame: Baseline (at the time of questionnaire completion)
|
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).
|
Baseline (at the time of questionnaire completion)
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Time Frame: Baseline (at the time of questionnaire completion)
|
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).
|
Baseline (at the time of questionnaire completion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go (TUG) Test Completion Time in Seconds
Time Frame: Baseline (at the time of questionnaire completion)
|
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.
|
Baseline (at the time of questionnaire completion)
|
|
Six-Minute Walk Test (6MWT) Distance in Meters
Time Frame: Baseline (at the time of questionnaire completion)
|
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.
|
Baseline (at the time of questionnaire completion)
|
|
Mini-Balance Evaluation Systems Test (Mini-BESTest) Total Score
Time Frame: Baseline (at the time of questionnaire completion)
|
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.
|
Baseline (at the time of questionnaire completion)
|
|
Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score
Time Frame: Baseline (at the time of questionnaire completion)
|
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.
|
Baseline (at the time of questionnaire completion)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2026
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
March 30, 2027
Study Registration Dates
First Submitted
March 18, 2026
First Submitted That Met QC Criteria
March 18, 2026
First Posted (Actual)
March 23, 2026
Study Record Updates
Last Update Posted (Actual)
July 15, 2026
Last Update Submitted That Met QC Criteria
July 14, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-03-130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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