Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-17 @ 7:31 AM
Study NCT ID:
NCT06404957
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2022-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Mindfulness-based Applied to Hemodialysis Patients on Psychosocial Adaptation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled experimental study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-04', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2024-05-04', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mindfulness-Based Practice Applied to Hemodialysis Patients', 'timeFrame': '6 weeks', 'description': 'Awareness-Based Practice Applied to Haemodialysis Patients is expected to affect the psychosocial adaptation of patients to their diseases.. Psychosocial Adjustment to Illness Self-Report Scale (PAIS-SR) was used to assess this outcome measure. Each item is scored on a scale ranging from 0 to 3. Largely negative differences since the disease are evaluated with a score of 3 and positive differences with a score of 0. In studies conducted with PAIS-SR, scores lower than 35 are evaluated as good psychosocial adjustment, scores between 35-51 as moderately good psychosocial adjustment, and scores higher than 51 as poor adjustment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Hemodialysis', 'Nursing', 'Psychosocial Adaptation'], 'conditions': ['Hemodialysis', 'Psychosocial Adaptation']}, 'referencesModule': {'references': [{'pmid': '29629280', 'type': 'BACKGROUND', 'citation': 'Sohn BK, Oh YK, Choi JS, Song J, Lim A, Lee JP, An JN, Choi HJ, Hwang JY, Jung HY, Lee JY, Lim CS. Effectiveness of group cognitive behavioral therapy with mindfulness in end-stage renal disease hemodialysis patients. Kidney Res Clin Pract. 2018 Mar;37(1):77-84. doi: 10.23876/j.krcp.2018.37.1.77. Epub 2018 Mar 31.'}, {'pmid': '15256293', 'type': 'BACKGROUND', 'citation': 'Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.'}, {'pmid': '28342990', 'type': 'BACKGROUND', 'citation': 'Gross CR, Reilly-Spong M, Park T, Zhao R, Gurvich OV, Ibrahim HN. Telephone-adapted Mindfulness-based Stress Reduction (tMBSR) for patients awaiting kidney transplantation. Contemp Clin Trials. 2017 Jun;57:37-43. doi: 10.1016/j.cct.2017.03.014. Epub 2017 Mar 22.'}], 'seeAlsoLinks': [{'url': 'https://nefroloji.org.tr/uploads/folders/file/registry_2019.pdf', 'label': 'Turkish Society of Nephrology Registry 2019'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to adapt mindfulness-based nursing interventions to hemodialysis patients and to investigate their effects on their psychosocial adjustment.\n\nThe main question\\[s\\] it aims to answer are:\n\nDo consciously applied nursing interventions increase the psychosocial adjustment to the disease in hemodialysis patients? Do mindfulness-based nursing interventions increase body and mind awareness in hemodialysis patients? Researchers will compare the experimental and control groups to see if mindfulness-based interventions have an effect on the psycho-social adjustment of hemodialysis patients.', 'detailedDescription': 'Primary Aims Test the efficacy of an adapted Mindfulness-Based Stress Reduction program to reduce symptoms and improve psychosocial adaption by 6 weeks.\n\nHypotheses\n\nPrimary: The mindfulness-based program increases the psychosocial adjustment to the disease in hemodialysis patients.\n\nSecondary: Mindfulness-based program increases body and mind awareness in hemodialysis patients.\n\nLong-range Goal: To develop evidence-based recommendations for non-pharmacologic strategies that provide psychosocial adaptation relief to hemodialysis patients and are safe, practical, and cost-effective.\n\nInterventions: The Mindfulness-based Applied program includes the curricular content of the standard 6 week. A trained teacher provides instruction in meditation techniques, including body scan, standing, sitting, and walking meditations, and mindful yoga.\n\nThe attention control consists of 90-minute online workshops. Audio recordings and written materials related to awareness exercises will be given to the participants at the end of each session so that they can do home practices.\n\nRecruiting Methods:\n\nIt will consist of hemodialysis patients receiving service from hemodialysis centers located in a province in the west of Turkey. The sample of the study will consist of individuals who voluntarily agree to participate in the study and who comply with the research criteria.\n\nData Collection Tools Mindfulness scale: Mindful Awareness Attention Scale (MAAS) The psychosocial adjustment to illness scale (PAIS-SR) Hemodialysis Stressor Scale (HSS)\n\nStudy Design: Randomized controlled experimental study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving hemodialysis treatment\n* Between the ages of 18-65\n\nExclusion Criteria:\n\n* Patients with acute renal failure\n* Current hospitalization, current ongoing chemotherapy or radiotherapy\n* Cognitive dysfunction or mental retardation\n* Current substance abuse\n* Entering hemodialysis due to current psychotropic drug use'}, 'identificationModule': {'nctId': 'NCT06404957', 'acronym': 'EMBAHPPA', 'briefTitle': 'Effect of Mindfulness-based Applied to Hemodialysis Patients on Psychosocial Adaptation', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'The Effect of Mindfulness-based Nursing Interventions Applied to Hemodialysis Patients on Psychosocial Adaptation', 'orgStudyIdInfo': {'id': 'SakaryaU-Hemodialysis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-based Applied', 'description': 'Patients in the experimental group were determined, 6-week, 90-minute-a-week mindfulness-based nursing interventions were taught, and group applications were made before the intervention and after; pre-test and post-test questionnaires were applied.', 'interventionNames': ['Behavioral: Mindfulness-based Applied']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control groups', 'description': 'No intervention was made in the control group. At the start of the intervention step of the study and after six weeks, pre-test and post-test questionnaires were applied to control groups.', 'interventionNames': ['Behavioral: Active Comparator: Control groups']}], 'interventions': [{'name': 'Mindfulness-based Applied', 'type': 'BEHAVIORAL', 'description': 'Mindfulness-Based Practices is planned to be an 8-week program of mindfulness meditation and gentle Hatha yoga taught in an online class for up to 14 participants.', 'armGroupLabels': ['Mindfulness-based Applied']}, {'name': 'Active Comparator: Control groups', 'type': 'BEHAVIORAL', 'description': 'No intervention will be made in this group.', 'armGroupLabels': ['Control groups']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54050', 'city': 'Sakarya', 'country': 'Turkey (Türkiye)', 'facility': 'Çiğdem Şen Tepe', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}], 'overallOfficials': [{'name': 'Çiğdem Şen Tepe, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sakarya University Faculty of Healt Science'}, {'name': 'Gülgün Durat, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sakarya University Faculty of Healt Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'GÜLGÜNDURAT', 'investigatorAffiliation': 'Sakarya University'}}}}