Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-01 @ 1:13 AM
Study NCT ID:
NCT05574595
Status:
UNKNOWN
Last Update Posted:
2022-10-10
First Post:
2022-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect on Pain and Comfort Associated With Fistula Puncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2022-10-05', 'studyFirstSubmitQcDate': '2022-10-07', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Efficacy of Music on Pain Level', 'timeFrame': '7 days', 'description': 'Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'The Efficacy of Music on Comfort Level', 'timeFrame': '7 days', 'description': 'Comfort Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'comfort'], 'conditions': ['Hemodialysis Patients']}, 'referencesModule': {'references': [{'pmid': '41148531', 'type': 'DERIVED', 'citation': 'Sayilan S, Sayilan AA, Kulakac N. The effect of self-selected soothing music on fistula puncture-related pain and comfort levels in hemodialysis patients: a randomized controlled, single-blind, single-center study. Int Urol Nephrol. 2025 Oct 28. doi: 10.1007/s11255-025-04877-5. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Purpose This study was carried out as the design of the targeted design in terms of targeting and comfort in the patient with hemodialysis.\n\nMaterial and Methods: It was successfully tested both in the control team of a hospital at the point of sale in Turkey and with experience. By block randomization method to randomize. Data were collected with "Patient identification formula", "Visual Analog Scale (VAS)" and "Hemodialysis Comfort Scale". Independent sample t-test was used in the analysis of the data, analysis of variance in repeated measurements and Cohen\'d was used to calculate the size.', 'detailedDescription': "It is appropriate to suggest a non-pharmacological rather clinical rather than a literature-free method, al. Also, due to the fact that the duration of anesthetic effect will expire from the dialysis treatment used (Subramanian et al., 2012).\n\nParticipant's care continues for inappropriate pain management. This quality standard is one of the criteria of a standard rather than a preference for a simple, reliable and inexpensive non-pharmacological choice.\n\nAs far as investigators know, there are very few studies investigating the effect of a patient's choice of music on pain following insertion of a needle into a fistula in hemodialysis patients. More focused on non-pharmacological types such as pharmacological and aromatherapy. Therefore, the aim of this study was to examine the effect of the type of music chosen by hemodialysis patients on pain and comfort associated with fistula puncture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be volunteering,\n* 18 years or older,\n* receiving hemodialysis treatment for at least 6 months\n* not any hearing problem.\n\nExclusion Criteria:\n\n* have hearing problem\n* not be volunteering.'}, 'identificationModule': {'nctId': 'NCT05574595', 'briefTitle': 'Effect on Pain and Comfort Associated With Fistula Puncture', 'organization': {'class': 'OTHER', 'fullName': 'Kırklareli University'}, 'officialTitle': 'The Effect of Self-selected Soothing Music on Fistula Puncture-related Pain and Comfort in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '2022/4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Mean of the Hemodialysis Comfort Scale scores of the experimental and group patients', 'description': 'To the Experimental Group; The information form and the short form of the comfort scale will be applied to the patient who is taken to the dialysis unit to start HD treatment.', 'interventionNames': ['Other: Music theraphy']}, {'type': 'NO_INTERVENTION', 'label': 'The mean of the Hemodialysis Comfort Scale scores of the control group patients', 'description': 'No procedure was performed on the patients in the control group.'}], 'interventions': [{'name': 'Music theraphy', 'type': 'OTHER', 'otherNames': ['There is no other name.'], 'description': 'In each session, the desired type of music will be played approximately 6 minutes before the procedure (Shabandokht-Zarmi et al., 2017). After the end of the music, the cannulation process will be performed by the dialysis nurse. The level of pain experienced by the patient immediately after needle insertion into the fistula will be evaluated with VAS by a research-independent nurse working in the dialysis unit.', 'armGroupLabels': ['The Mean of the Hemodialysis Comfort Scale scores of the experimental and group patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aylin AYDIN SAYILAN, PhD', 'role': 'CONTACT', 'email': 'aylin.sayilan@klu.du.tr', 'phone': '+902882145547'}], 'overallOfficials': [{'name': 'Nurşen KULAKAÇ, pHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gümüşhane Universıty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kırklareli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Aylin Aydin Sayilan', 'investigatorAffiliation': 'Kırklareli University'}}}}