Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 5:45 PM
Study NCT ID:
NCT07488351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Self-Compassion and Self-Efficacy in Parkinson's Disease: Associations With Symptoms, Function, and Quality of Life"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Compassion Scale (SCS) Total Score', 'timeFrame': 'Baseline (at the time of questionnaire completion)', 'description': 'Self-compassion will be measured using the Self-Compassion Scale (SCS), a validated self-report instrument assessing multiple dimensions of self-compassion. The total score will be calculated, with higher scores indicating greater self-compassion.'}, {'measure': 'Self-Efficacy for Managing Chronic Disease 6-Item Scale Total Score', 'timeFrame': 'Baseline (at the time of questionnaire completion)', 'description': 'Self-efficacy will be measured using the Self-Efficacy for Managing Chronic Disease 6-Item Scale, a validated self-report measure. The total score will be calculated, with higher scores indicating greater perceived self-efficacy.'}, {'measure': "Unified Parkinson's Disease Rating Scale (UPDRS) Total Score", 'timeFrame': 'Baseline (at the time of questionnaire completion)', 'description': "Symptom severity will be measured using the Unified Parkinson's Disease Rating Scale (UPDRS), a validated clinician-rated instrument assessing motor and non-motor symptoms. Higher total scores indicate greater disease severity."}], 'secondaryOutcomes': [{'measure': 'Timed Up and Go (TUG) Test Completion Time in Seconds', 'timeFrame': 'Baseline (at the time of questionnaire completion)', 'description': '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.'}, {'measure': 'Six-Minute Walk Test (6MWT) Distance in Meters', 'timeFrame': 'Baseline (at the time of questionnaire completion)', 'description': '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.'}, {'measure': 'Mini-Balance Evaluation Systems Test (Mini-BESTest) Total Score', 'timeFrame': 'Baseline (at the time of questionnaire completion)', 'description': '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.'}, {'measure': "Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score", 'timeFrame': 'Baseline (at the time of questionnaire completion)', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease, Symptom Severity, Functional Status, Quality of Life, Self-compassion, and Self-efficacy']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinically diagnosed Parkinson's disease\n\nHoehn and Yahr stage 1-3\n\nAge between 40 and 85 years\n\nSufficient cognitive function to communicate (Mini-Mental State Examination \\[MMSE\\] score ≥ 24)\n\nPatients attending the Movement Disorders Outpatient Clinic of the Neurology Department\n\nWillingness to participate and provide informed consent\n\nExclusion Criteria:\n\n* Presence of psychiatric disorders (e.g., major depression, psychotic disorders)\n\nDiagnosis of advanced dementia\n\nPresence of uncontrolled systemic chronic diseases (e.g., diabetes mellitus, hypertension) or severe cardiovascular or respiratory conditions\n\nPresence of additional orthopedic or neurological conditions that may affect test performance\n\nSevere visual or hearing impairments that could interfere with assessments\n\nInability to cooperate adequately with the physiotherapist during assessments"}, 'identificationModule': {'nctId': 'NCT07488351', 'briefTitle': '"Self-Compassion and Self-Efficacy in Parkinson\'s Disease: Associations With Symptoms, Function, and Quality of Life"', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': '"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"', 'orgStudyIdInfo': {'id': '2026-03-130'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Self-Report Questionnaire Assessment', 'type': 'OTHER', 'description': 'This 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.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}