Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:33 AM
Study NCT ID:
NCT07370857
Status:
COMPLETED
Last Update Posted:
2026-01-27
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Music Medicine on Anxiety and Pain Levels in Women Undergoing Embryo Transfer: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Randomization was performed using the sealed envelope method to ensure allocation concealment; therefore, the investigator did not know the group assignments until the point of intervention. Due to the nature of the music medicine intervention, the participants and the investigator collecting the data could not be masked during the procedure. However, to minimize bias, the statistical analysis will be conducted by a researcher blinded to the group allocations.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Music Medicine Group (Arm 1) Label: Music Medicine Group\n\n Arm Type: Experimental\n\n Description: Participants listen to patient-selected music via noise-canceling headphones throughout the embryo transfer procedure and for 15 minutes post-procedure, in addition to standard care.\n2. Control Group (Arm 2) Label: Control Group\n\nArm Type: No Intervention\n\nDescription: Participants receive standard clinical care for the embryo transfer procedure without any music medicine intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-20', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State Anxiety Score', 'timeFrame': 'Measured at two time points: baseline (pre-test, upon admission to the room) and 15 minutes after the embryo transfer procedure (post-test).', 'description': 'Measured using the Spielberger State-Trait Anxiety Inventory (STAI). Only the "State" subscale is used to assess the current level of anxiety related to the embryo transfer procedure. The score ranges from 20 to 80, where higher scores indicate higher levels of anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Management', 'Infertility (IVF Patients)', 'Anxiety']}, 'descriptionModule': {'briefSummary': "This study was designed to investigate the effects of music medicine on anxiety, pain, and vital signs in women undergoing embryo transfer. The study followed a randomized controlled design and was conducted at the IVF unit of a university hospital. The sample consisted of women who met the specified inclusion criteria, and participants were assigned to the intervention and control groups using randomization.\n\nData collection tools included a socio-demographic characteristics form, a vital signs recording form (blood pressure, pulse, respiratory rate, and oxygen saturation), the State-Trait Anxiety Inventory (STAI-I and II), and the Visual Analogue Scale (VAS). The intervention group listened to patient-selected music during the embryo transfer process, while the control group received standard care. Measurements were taken before, during, and after the embryo transfer.\n\nThe obtained data were analyzed using appropriate statistical methods to evaluate the effects of music on anxiety, pain levels, and vital signs. This study aims to improve women's embryo transfer experiences by contributing to nursing care and reproductive health practices.", 'detailedDescription': 'The study evaluates the effect of music medicine on anxiety and pain levels during embryo transfer. Participants in the intervention group listen to patient-selected music via noise-canceling headphones. The process includes baseline assessments of vital signs and anxiety, followed by post-intervention measurements 15 minutes after the procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen undergoing embryo transfer.\n\nAges 18 to 45 years (or your specific age range).\n\nLiteracy in Turkish to complete the inventories.\n\nVoluntarily agreeing to participate in the study.\n\nExclusion Criteria:\n\nPatients with hearing impairment.\n\nPatients with cognitive or psychiatric disorders that prevent completion of the inventory.\n\nPatients who have taken analgesic or anxiolytic medication within the last 24 hours.'}, 'identificationModule': {'nctId': 'NCT07370857', 'briefTitle': 'The Effect of Music Medicine on Anxiety and Pain Levels in Women Undergoing Embryo Transfer: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'The Effect of Music Medicine on Anxiety and Pain Levels in Women Undergoing Embryo Transfer: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Hasan Kalyoncu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music Medicine Group', 'description': 'Patients in this group receive music medicine intervention in addition to standard care during the embryo transfer process.', 'interventionNames': ['Behavioral: "Patient-Selected Music Medicine']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants receive only the standard clinical procedures and routine care for embryo transfer without any music intervention.'}], 'interventions': [{'name': '"Patient-Selected Music Medicine', 'type': 'BEHAVIORAL', 'description': 'Participants in the intervention group listen to their pre-selected music through high-quality, over-ear active noise-canceling headphones to ensure acoustic isolation. The music intervention begins immediately before the embryo transfer, continues throughout the procedure, and extends for 15 minutes in the recovery room. The volume is adjusted by the patient to a comfortable level, and disposable covers are used on the headphones for hygiene.', 'armGroupLabels': ['Music Medicine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Sanliurfa', 'state': 'Şanlıurfa', 'country': 'Turkey (Türkiye)', 'facility': 'Harran University', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared to protect participant privacy and because the data are currently being used as part of a doctoral dissertation. Results will be disseminated through publication in peer-reviewed journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'helin kalır', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}