Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-28 @ 5:30 PM
Study NCT ID:
NCT05841459
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2023-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spiritual Well-being, Self-compassion, Physical Symptoms Distress and Demoralization Among HD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-01', 'studyFirstSubmitDate': '2023-04-19', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'demoralization', 'timeFrame': 'during the procedure', 'description': "The demoralization scale is a validated multidimensional measure that assesses patients' status of demoralization"}], 'secondaryOutcomes': [{'measure': 'spiritual well-being', 'timeFrame': 'during the procedure', 'description': "The spiritual well-being scale is a validated multidimensional measure that assesses patients' spirituality"}, {'measure': 'self compassion', 'timeFrame': 'during the procedure', 'description': "The self-compassion scale is a validated multidimensional measure that assesses patients' level of self-compassion"}, {'measure': 'physical symptom distress', 'timeFrame': 'during the procedure', 'description': "The physical symptom distress scale is a validated multidimensional measure that assesses patients' level of physical symptom distress"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spirituality', 'self-compassion', 'demoralization'], 'conditions': ['Demoralization']}, 'descriptionModule': {'briefSummary': 'To explore the associations between spiritual well-being, self-compassion, physical symptoms distress and demoralization among hemodialysis patients', 'detailedDescription': 'The aims of this study is to explore the associations between spiritual well-being, self-compassion, physical symptom distress and demoralization in hemodialysis patients.\n\nA cross-sectional correlation design will be used. We use convenient sample to recruit hemodialysis patients in a regional teaching hospital in the southern Taiwan. The research data is collected with a pact of self-administrated questionnaire including Chinese version of the Demoralization Scale , FACITsp-12 Scale, Self-Compassion Scale, and Physical Symptom Distress Scale. SPSS statistical software will be used to data analysis. Analysis methods included descriptive and inferential statistics. Finally, multiple linear regression will be used to test the predictors of demoralization. The research results will offer health providers to identify symptoms related to demoralization earlier and provide appropriate care to patients to adapt the long treatment process and improve their quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hemodialysis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hemodialysis patient who agrees to join this study.\n* The participant is over 20 years old.\n* The participant has a clear consciousness and can communicate in Mandarin and Taiwanese to answer the questionnaire.\n\nExclusion Criteria:\n\n* The hearing impaired cannot communicate.\n* Intensive care unit or inpatients.\n* Mental disorders or dementia such as depression, schizophrenia, and anxiety diagnosed by a physician.\n* Those who are seriously unwell or have unstable vital signs.'}, 'identificationModule': {'nctId': 'NCT05841459', 'briefTitle': 'Spiritual Well-being, Self-compassion, Physical Symptoms Distress and Demoralization Among HD Patients', 'nctIdAliases': ['NCT06097858'], 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung University of Science and Technology'}, 'officialTitle': 'Study of Spiritual Well-being, Self-compassion, Physical Symptoms Distress and Demoralization Among Hemodialysis Patients', 'orgStudyIdInfo': {'id': '202212044RIND'}}, 'contactsLocationsModule': {'locations': [{'zip': '333 03', 'city': 'Taoyuan', 'state': 'N/A = Not Applicable', 'country': 'Taiwan', 'facility': 'Chang Gung University of Science and Technology', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'overallOfficials': [{'name': 'Ya-Chu Hsiao, EdD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ya-Chu Hsiao', 'investigatorAffiliation': 'Chang Gung University of Science and Technology'}}}}