Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT06977867
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-21
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Stress Ball Use on Comfort, Anxiety, and Patient Satisfaction in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of anxiety', 'timeFrame': '1 month', 'description': 'The anxiety levels of patients included in the study will be assessed prior to the intervention using the Visual Analog Scale (VAS). The VAS scores will be categorized as follows: low anxiety (0-3), moderate anxiety (4-6), and high anxiety (7-10).'}, {'measure': "Patient's comfort", 'timeFrame': '1 month', 'description': 'The comfort levels of patients using the stress ball during the hemodialysis procedure will be assessed using the Hemodialysis Comfort Scale. The minimum score obtainable from the scale (20) indicates low comfort, while the maximum score (100) reflects high comfort.'}, {'measure': 'Level of patient satisfaction', 'timeFrame': '1 month', 'description': 'Patient satisfaction during the hemodialysis procedure among those using the stress ball will be assessed using the Visual Analog Patient Satisfaction Scale. VAS scores will be categorized as follows: low satisfaction (0-3), moderate satisfaction (4-6), and high satisfaction (7-10).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis Patients']}, 'referencesModule': {'references': [{'pmid': '25777665', 'type': 'BACKGROUND', 'citation': 'Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, Zhao MH, Lv J, Garg AX, Knight J, Rodgers A, Gallagher M, Kotwal S, Cass A, Perkovic V. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet. 2015 May 16;385(9981):1975-82. doi: 10.1016/S0140-6736(14)61601-9. Epub 2015 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'Chronic kidney disease represents a significant public health issue both in Türkiye and worldwide, with the majority of patients undergoing hemodialysis treatment. Individuals receiving hemodialysis often experience not only physical discomfort but also psychological distress, including heightened anxiety and reduced comfort. The aim of this study is to evaluate the effects of stress ball use on comfort, anxiety, and patient satisfaction among hemodialysis patients. The stress ball is a simple and cost-effective non-pharmacological intervention that aids individuals in managing stress by redirecting their attention. Notably, this study is unique in simultaneously investigating comfort, anxiety, and satisfaction parameters within this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '98 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18 years of age or older\n* Being literate\n* Having no visual or hearing impairments\n* Being able to communicate verbally\n* Having no physical disability that would prevent the use of a stress ball\n* Not having a diagnosed anxiety disorder and not using medication for it\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Currently using sedative medications\n* Having a diagnosed psychiatric disorder\n* Having any physical limitation that prevents squeezing a stress ball'}, 'identificationModule': {'nctId': 'NCT06977867', 'acronym': 'Stress Ball', 'briefTitle': 'The Effect of Stress Ball Use on Comfort, Anxiety, and Patient Satisfaction in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bitlis Eren University'}, 'officialTitle': 'The Effect of Stress Ball Use on Comfort, Anxiety, and Patient Satisfaction in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '2024/8-2 and E.6610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stress Ball', 'description': 'All hemodialysis patients who meet the inclusion criteria will be asked to squeeze a stress ball during their dialysis sessions (3 times a week for 1 month, totaling 12 sessions). Anxiety, comfort, and patient satisfaction levels will be assessed using three measurements: a pre-test before the intervention, a mid-test at the end of the 6th session (2nd week), and a post-test after the 12th session. Patients will be instructed to use the stress ball throughout their dialysis session. They will be asked to squeeze the ball for at least 10-15 minutes during each session.', 'interventionNames': ['Device: Stress Ball']}, {'type': 'OTHER', 'label': 'Control', 'description': 'The hemodialysis patients in the control group will not use the stress ball and will receive standard care throughout the study period. Similar to the intervention group, levels of anxiety, comfort, and patient satisfaction will be assessed at three time points: prior to the intervention (pre-test), at the end of the second week (after the 6th session), and at the end of the fourth week (post-test, after the 12th session).', 'interventionNames': ['Other: standard care']}], 'interventions': [{'name': 'Stress Ball', 'type': 'DEVICE', 'description': 'All hemodialysis patients who meet the inclusion criteria will be asked to squeeze a stress ball during their dialysis sessions (3 times a week for 1 month, totaling 12 sessions). Anxiety, comfort, and patient satisfaction levels will be assessed using three measurements: a pre-test before the intervention, a mid-test at the end of the 6th session (2nd week), and a post-test after the 12th session. Patients will be instructed to use the stress ball throughout their dialysis session. They will be asked to squeeze the ball for at least 10-15 minutes during each session.', 'armGroupLabels': ['Stress Ball']}, {'name': 'standard care', 'type': 'OTHER', 'description': 'The hemodialysis patients in the control group will not use the stress ball and will receive standard care throughout the study period. Similar to the intervention group, levels of anxiety, comfort, and patient satisfaction will be assessed at three time points: prior to the intervention (pre-test), at the end of the second week (after the 6th session), and at the end of the fourth week (post-test, after the 12th session).', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13200', 'city': 'Bitlis', 'state': 'Tatvan', 'country': 'Turkey (Türkiye)', 'facility': 'Bitlis State Hospital', 'geoPoint': {'lat': 38.40115, 'lon': 42.10784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bitlis Eren University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Hasret Topalı', 'investigatorAffiliation': 'Bitlis Eren University'}}}}