Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
Study NCT ID:
NCT04277559
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2020-02-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Music on Postoperative Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spielberg State-Trait Anxiety Inventory (STAI) score', 'timeFrame': '4 hours', 'description': 'The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety. Preoperative and postoperative STAI I score questions will be asked.'}], 'secondaryOutcomes': [{'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': '24 hours', 'description': "11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained."}, {'measure': 'The quality of postoperative functional recovery (QoR-40) score', 'timeFrame': '24 hours', 'description': 'The quality of postoperative functional recovery will assess using the QoR-40, which assesses physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score ranges from 40 (poorest quality of recovery) to 200 (the best quality of recovery). The QoR-40 will administer one day before surgery in outpatient clinics of anesthesiology, and before discharge from hospital on the first postoperative day.'}, {'measure': 'Patient satisfaction score', 'timeFrame': '24 hours', 'description': 'Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 7) verbally administered questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient preferential music', 'Postoperative anxiety', 'Classical music'], 'conditions': ['Anxiety Postoperative']}, 'referencesModule': {'references': [{'pmid': '39143577', 'type': 'DERIVED', 'citation': 'Akelma FK, Altinsoy S, Nalbant B, Ozkan D, Ergil J. Comparison of classical and patient-preferred music on anxiety and recovery after inguinal hernia repair: a prospective randomized controlled study. Perioper Med (Lond). 2024 Aug 14;13(1):89. doi: 10.1186/s13741-024-00434-3.'}]}, 'descriptionModule': {'briefSummary': 'In this study, it is planned to compare the effect of listening to the music preferred by the patient and classical music on postoperative anxiety.', 'detailedDescription': 'Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II. 225 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 will be included in our study. Preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into three groups as preoperative patient preferential music, classical music and not played. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones. The STAI will be repeated at postoperative, the Numeric Rating Scale (NRS) and patient satisfaction will be measured at postoperative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergo inguinal hernia surgery under general anesthesia,\n* Being the ability to speak, read and write the Turkish language\n\nExclusion Criteria:\n\n* Poor vision\n* Significant hearing loss\n* Dementia\n* Active opioid use\n* Regular use of anxiolytics or discontinuation of them on the day of surgery\n* Unwillingness to participate in the study\n* Unwillingness to listening to music'}, 'identificationModule': {'nctId': 'NCT04277559', 'briefTitle': 'The Effect of Music on Postoperative Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Diskapi Training and Research Hospital'}, 'officialTitle': 'Comparison of the Effect of Patient Preferred Music on Postoperative Anxiety', 'orgStudyIdInfo': {'id': 'music'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patient preferential music', 'description': 'The preference of the patients will be listened to preoperatively through the headphones.', 'interventionNames': ['Other: Patient preferential music']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classical music', 'description': 'Classical music (Four Seasons from Vivaldi) will be listened to preoperatively through the headphones.', 'interventionNames': ['Other: Classical music']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No music', 'description': 'the patients will not listen.', 'interventionNames': ['Other: No music']}], 'interventions': [{'name': 'Patient preferential music', 'type': 'OTHER', 'description': 'Patients will listen to their preferred music through the headphones before surgery.', 'armGroupLabels': ['Patient preferential music']}, {'name': 'Classical music', 'type': 'OTHER', 'description': 'Patients will listen to classical music through headphones before surgery.', 'armGroupLabels': ['Classical music']}, {'name': 'No music', 'type': 'OTHER', 'description': 'Patients will not listen to music.', 'armGroupLabels': ['No music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Gölbaşı', 'country': 'Turkey (Türkiye)', 'facility': 'Dışkapı Yıldırım Beyazıt Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Diskapi Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesiology and reanimation specialist doctor', 'investigatorFullName': 'Fatma Kavak Akelma', 'investigatorAffiliation': 'Ankara Diskapi Training and Research Hospital'}}}}