Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT05296018
Status:
COMPLETED
Last Update Posted:
2022-11-25
First Post:
2022-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single (Participant) Mandala and control group'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is an experimental study with pre-test and post-test control groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-23', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The fatigue severity scale', 'timeFrame': '1. week', 'description': 'The fatigue severity scale is a measurement of fatigue impact on functioning. It is a short, nine-item self-report questionnaire. Its application is very simple and quick.. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician.'}, {'measure': 'The fatigue severity scale', 'timeFrame': '4. week', 'description': 'The fatigue severity scale is a measurement of fatigue impact on functioning. It is a short, nine-item self-report questionnaire. Its application is very simple and quick.. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician.'}, {'measure': 'The fatigue severity scale', 'timeFrame': '8. week', 'description': 'The fatigue severity scale is a measurement of fatigue impact on functioning. It is a short, nine-item self-report questionnaire. Its application is very simple and quick.. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician.'}, {'measure': 'The psychological well-being scale', 'timeFrame': '1. week', 'description': 'The eight-item Psychological Well-Being Scale identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life.This is an 8-item selfreported, 7-point Likert-type measurement scale (1=strongly disagree to 7=strongly agree). Higher scores indicated a higher level of psychological well-being.'}, {'measure': 'The psychological well-being scale', 'timeFrame': '4. week', 'description': 'The eight-item Psychological Well-Being Scale identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life.This is an 8-item selfreported, 7-point Likert-type measurement scale (1=strongly disagree to 7=strongly agree). Higher scores indicated a higher level of psychological well-being.'}, {'measure': 'The psychological well-being scale', 'timeFrame': '8. week', 'description': 'The eight-item Psychological Well-Being Scale identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life.This is an 8-item selfreported, 7-point Likert-type measurement scale (1=strongly disagree to 7=strongly agree). Higher scores indicated a higher level of psychological well-being.'}, {'measure': 'The Ways of Coping Inventory (WCI)', 'timeFrame': '1. week', 'description': 'The Ways of Coping Inventory (WCI) was developed by Folkman and Lazarus (1980) in order to determine the ways by which individuals cope with general or specific stress situations. The scale is a 30-item likert type scale. The answers to the items of the scale are given in four stages, moving from "does not apply or not used" (0) to "used a great deal" Higher scores in "Self-confident", "Optimistic" and "Seeking of social support" (Approach based coping) mean better coping, and higher scores in "Submissive" and "Helpless styles" (Avoidance based coping) mean worse coping.'}, {'measure': 'The Ways of Coping Inventory (WCI)', 'timeFrame': '4. week', 'description': 'The Ways of Coping Inventory (WCI) was developed by Folkman and Lazarus (1980) in order to determine the ways by which individuals cope with general or specific stress situations. The scale is a 30-item likert type scale. The answers to the items of the scale are given in four stages, moving from "does not apply or not used" (0) to "used a great deal" Higher scores in "Self-confident", "Optimistic" and "Seeking of social support" (Approach based coping) mean better coping, and higher scores in "Submissive" and "Helpless styles" (Avoidance based coping) mean worse coping.'}, {'measure': 'The Ways of Coping Inventory (WCI)', 'timeFrame': '8. week', 'description': 'The Ways of Coping Inventory (WCI) was developed by Folkman and Lazarus (1980) in order to determine the ways by which individuals cope with general or specific stress situations. The scale is a 30-item likert type scale. The answers to the items of the scale are given in four stages, moving from "does not apply or not used" (0) to "used a great deal" Higher scores in "Self-confident", "Optimistic" and "Seeking of social support" (Approach based coping) mean better coping, and higher scores in "Submissive" and "Helpless styles" (Avoidance based coping) mean worse coping.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fatigue', 'Psychological Well-Being', 'Stress'], 'conditions': ['Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '34071674', 'type': 'RESULT', 'citation': 'Choi H, Hahm SC, Jeon YH, Han JW, Kim SY, Woo JM. The Effects of Mindfulness-Based Mandala Coloring, Made in Nature, on Chronic Widespread Musculoskeletal Pain: Randomized Trial. Healthcare (Basel). 2021 May 28;9(6):642. doi: 10.3390/healthcare9060642.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effect of mandala on coping with fatigue, psychological well-being and stress in patients treated with hemodialysis', 'detailedDescription': 'The Effect of Mandala on Coping with Fatigue, Psychological Well-Being and Stress in Patients Treated with Hemodialysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be over 18\n* Ability to communicate adequately\n* Absence of psychiatric problems\n* Volunteering to participate in the research\n* Receiving hemodialysis treatment for at least 6 months\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05296018', 'briefTitle': 'The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Sabahattin Zaim University'}, 'officialTitle': 'The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis', 'orgStudyIdInfo': {'id': '2022-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mandala', 'description': 'Mandala coloring page', 'interventionNames': ['Other: Mandala coloring page']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Routine maintenance will be applied'}], 'interventions': [{'name': 'Mandala coloring page', 'type': 'OTHER', 'description': 'Mandala program will be applied three days a week (30 minutes) for 8 weeks.', 'armGroupLabels': ['Mandala']}]}, 'contactsLocationsModule': {'locations': [{'zip': '340340', 'city': 'Istanbul', 'state': 'Güneydoğu Anadolu Bölgesi', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Sabahattin Zaim University, Faculty of Health Sciences', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34303', 'city': 'Istanbul', 'state': 'Küçükçekmece', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Sabahattin Zaim University, Faculty of Health Sciences', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Sabahattin Zaim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zülfünaz ÖZER', 'investigatorAffiliation': 'Istanbul Sabahattin Zaim University'}}}}