Anxiety and Physiological Responses in Ambulatory Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-selected Music intervention, Fixed-music Music intervention.
- Who it may be relevant to
- Registry conditions: Anxiety, Heart Rate Variability (HRV), Heart Rate, Blood Pressure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Subjective Anxiety and Physiological Parameters in First-Time Ambulatory Surgery Patients
Overview
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.
Detailed description
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.
Interventions
- Behavioral Self-selected Music intervention
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 c - Behavioral Fixed-music Music intervention
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 t
Primary outcome measures
- Subjective Anxiety: Visual Analog Scale for Anxiety (VAS-A) [Time frame: Baseline (T0, pre-intervention); during the 10-minute intervention (T1); immediately after surgery in the postoperative recovery period (T2)]]
- Subjective Anxiety: State Anxiety Inventory (STAI-S) [Time frame: Baseline (T0, pre-intervention); immediately after surgery in the postoperative recovery period (T2)]]
- Subjective Anxiety: Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Time frame: Baseline (T0, pre-intervention)]
Secondary outcome measures (4)
- Heart Rate Variability (HRV) [Time frame: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)]
- Systolic Blood Pressure [Time frame: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)]
- Diastolic Blood Pressure [Time frame: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)]
- Heart Rate [Time frame: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)]
Eligibility criteria
Inclusion criteria
- Be at least 18 years old.
- Undergo outpatient surgery for the first time.
- Be mentally clear and able to communicate in Chinese and complete the questionnaire.
- Agree to wear physiological monitoring devices and sign the consent form.
Exclusion criteria
- Hearing impairment or the need to use a hearing aid.
- Currently using sleeping pills/sedatives or having a mental illness.
- Severe cardiovascular disease or having an implanted pacemaker.
- Diseases that affect autonomic nervous system function.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07476820 · 115011