Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 9:23 AM
Study NCT ID:
NCT07476820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anxiety and Physiological Responses in Ambulatory Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Anxiety: Visual Analog Scale for Anxiety (VAS-A)', 'timeFrame': 'Baseline (T0, pre-intervention); during the 10-minute intervention (T1); immediately after surgery in the postoperative recovery period (T2)]', 'description': 'Subjective anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A; score range: 0-10). Higher scores indicate higher levels of anxiety. Measurements will be recorded at baseline (T0, pre-intervention), during the 10-minute intervention (T1), and immediately after surgery in the postoperative recovery period (T2).'}, {'measure': 'Subjective Anxiety: State Anxiety Inventory (STAI-S)', 'timeFrame': 'Baseline (T0, pre-intervention); immediately after surgery in the postoperative recovery period (T2)]', 'description': 'Subjective anxiety will be assessed using the State Anxiety Inventory (STAI-S; score range: 20-80). Higher scores indicate higher levels of anxiety. Measurements will be recorded at baseline (T0, pre-intervention) and immediately after surgery in the postoperative recovery period (T2).'}, {'measure': 'Subjective Anxiety: Amsterdam Preoperative Anxiety and Information Scale (APAIS)', 'timeFrame': 'Baseline (T0, pre-intervention)', 'description': 'Subjective anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS; score range: 6-30). Higher scores indicate higher levels of anxiety. Measurements will be recorded at baseline (T0, pre-intervention).'}], 'secondaryOutcomes': [{'measure': 'Heart Rate Variability (HRV)', 'timeFrame': 'Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)', 'description': 'Heart rate variability (HRV) will be recorded using a wrist-worn physiological monitor (Heart Rhythm Master). HRV parameters will include time-domain and frequency-domain indices.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)', 'description': 'Systolic blood pressure will be recorded using a wrist-worn physiological monitor (Heart Rhythm Master).'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)', 'description': 'Diastolic blood pressure will be recorded using a wrist-worn physiological monitor (Heart Rhythm Master).'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)', 'description': 'Heart rate will be recorded using a wrist-worn physiological monitor (Heart Rhythm Master).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Music', 'Anxiety', 'Ambulatory Surgery', 'Physiological Indicators'], 'conditions': ['Anxiety', 'Heart Rate Variability (HRV)', 'Heart Rate', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of music intervention on subjective anxiety and physiological indicators, including heart rate, blood pressure, and heart rate variability, in first-time ambulatory surgery patients, and to compare the differential effects between self-selected and standardized music interventions.', 'detailedDescription': "This study aims to investigate the effects of music intervention on subjective anxiety and physiological parameters in first-time ambulatory surgery patients. The physiological parameters include heart rate, blood pressure, and heart rate variability (HRV), while subjective anxiety will be assessed using standardized measurement scales. The study also compares the differential effects of two types of music interventions-self-selected music and standardized classical music-on patients' anxiety and physiological parameters. During the intervention, all music playback conditions, including timing, environment, and use of headphones, will be kept consistent to ensure comparability between groups. The results of this study will provide evidence on the clinical applicability of music as a non-pharmacological strategy for anxiety management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be at least 18 years old.\n2. Undergo outpatient surgery for the first time.\n3. Be mentally clear and able to communicate in Chinese and complete the questionnaire.\n4. Agree to wear physiological monitoring devices and sign the consent form.\n\nExclusion Criteria:\n\n1. Hearing impairment or the need to use a hearing aid.\n2. Currently using sleeping pills/sedatives or having a mental illness.\n3. Severe cardiovascular disease or having an implanted pacemaker.\n4. Diseases that affect autonomic nervous system function.'}, 'identificationModule': {'nctId': 'NCT07476820', 'briefTitle': 'Anxiety and Physiological Responses in Ambulatory Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Da-Yeh University'}, 'officialTitle': 'Subjective Anxiety and Physiological Parameters in First-Time Ambulatory Surgery Patients', 'orgStudyIdInfo': {'id': '115011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-selected Music Group', 'description': 'Participants may select and listen to light instrumental music, classical music, or natural sounds from the music list provided by the study according to their personal preference.', 'interventionNames': ['Behavioral: Self-selected Music intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fixed-music Group', 'description': 'Playing the same piece of classical music pre-selected by the research team.', 'interventionNames': ['Behavioral: Fixed-music Music intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No-music', 'description': 'Participants wore earmuff headphones and wearable physiological monitoring devices to measure HRV, with no music played during the process.'}], 'interventions': [{'name': 'Self-selected Music intervention', 'type': 'BEHAVIORAL', 'description': 'This study adopted a randomized controlled trial (RCT) design. Eligible outpatients undergoing surgery for the first time were recruited and randomly assigned, using block randomization, into three groups: a self-selected music group, a fixed-music group, and a control group. During the intervention period, participants in the music groups listened to music (self-selected or fixed) for 10 minutes in the preoperative nursing waiting area, while the control group received routine care. Data were collected at three time points: before surgery (T0), during the intervention (T1), and after surgery (T2).', 'armGroupLabels': ['Self-selected Music Group']}, {'name': 'Fixed-music Music intervention', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to the standardized music group will listen to pre-selected classical music provided by the research team, aimed at promoting relaxation and focused attention. The selected music maintains a stable tempo of 60-70 beats per minute and is delivered at a sound level below 60 dB to ensure comfort and safety. Music will be administered via headphones under standardized conditions. The timing, duration, listening environment, and outcome measurement procedures will be identical to those used in the personalized music group to ensure consistency of intervention across study arms', 'armGroupLabels': ['Fixed-music Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Da-Yeh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yi-chen Wu', 'investigatorAffiliation': 'Da-Yeh University'}}}}