Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT06659133
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2024-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Music On Pain and Anxiety Paddle Edometrial Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was conducted as a randomized controlled trial to investigate the effect of music recital on pain and anxiety in women undergoing pipelined endometrial biopsy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiety', 'timeFrame': '30 min', 'description': 'State and Trait Anxiety Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'anxiety'], 'conditions': ['Gynecologic Nursing']}, 'descriptionModule': {'briefSummary': 'This study was conducted as a randomized controlled trial to investigate the effect of music recital on pain and anxiety in women undergoing pipelined endometrial biopsy.', 'detailedDescription': 'This study was conducted as a randomized controlled trial to investigate the effect of music recital on pain and anxiety in women undergoing pipelined endometrial biopsy. The data were collected in the intervention room of the mixed service of a state hospital in Ankara between December 2023 and April 2024. Power analysis was performed with the G\\*Power 3.1 program to determine the number of people to be included in the study. The study was conducted with a total of 64 women, 32 in the control group and 32 in the experimental group. The data were collected using the Personal Information Form, "Visual Comparison Scale" to assess the severity of pain, and "State and Trait Anxiety Scale" to determine the level of anxiety. The experimental group listened to acemashiran maqam music, while the control group received routine care. There was no significant difference between the control and experimental groups in the distribution of socio-demographic characteristics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 and over who underwent endometrial biopsy for the first time\n\nExclusion Criteria:\n\nThose who did not fill out the consent form, Those who were illiterate, Those who were receiving inpatient treatment during the study, Those with psychiatric illness (dementia, psychosis, etc.), Those who were on regular medication (such as analgesics, anxiolytics or sedatives), Those who had communication problems (vision, hearing and perception problems), Women who were in pain before the procedure were not included.'}, 'identificationModule': {'nctId': 'NCT06659133', 'briefTitle': 'Effect of Music On Pain and Anxiety Paddle Edometrial Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Adiyaman University Research Hospital'}, 'officialTitle': 'In Women Undergoıng Paddle Endometrıal Bıopsy Applıed Musıc Recıtal Effect On Paın And Anxıety', 'orgStudyIdInfo': {'id': 'lokmanhekim universty'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'control group received routine care during pipelined endometrial biopsy.'}, {'type': 'EXPERIMENTAL', 'label': 'Music', 'description': 'The experimental group listened to acemashiran maqam music during pipelined endometrial biopsy.', 'interventionNames': ['Other: Music intervention']}], 'interventions': [{'name': 'Music intervention', 'type': 'OTHER', 'description': 'The women participating in the study were divided into control and experimental groups.\n\nThe control group included women who underwent pipelle endometrial biopsy with routine care, and the experimental group included women who underwent pipelle endometrial biopsy accompanied by music. Pipelle endometrial biopsy was performed by the same physician working in the Department of Obstetrics and Gynecology at the hospital. Patients in both groups were interviewed 10 minutes before the endometrial biopsy procedure and the Personal Information Form and State and Trait Anxiety Scale were applied. The application of the GKO was explained to the patients before the pipelle endometrial biopsy procedure. Before the pipelle endometrial biopsy, all patients were routinely given local anesthesia with 8 cc of 2% lidocaine solution and waited for 5 minutes after the application of local anesthesia.\n\nDuring the pipelle endometrial biopsy, the experimental group was given a music recital from an mp3 play', 'armGroupLabels': ['Music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02100', 'city': 'Adıyaman', 'country': 'Turkey (Türkiye)', 'facility': 'Didem Simsek Kucukkelepce', 'geoPoint': {'lat': 37.76441, 'lon': 38.27629}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adiyaman University Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd', 'investigatorFullName': 'Didem Kucukkelepce', 'investigatorAffiliation': 'Lokman Hekim University'}}}}