Anxiety and Physiological Responses in Ambulatory Surgery

NCT07476820 | Not Yet Recruiting

• 1 other identifier: 115011
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Rate; Anxiety; Heart Rate Variability (HRV); Blood Pressure

Keywords

Music; Anxiety; Ambulatory Surgery; Physiological Indicators

Outcome Measures

Primary Outcomes (3)

• Subjective Anxiety: Visual Analog Scale for Anxiety (VAS-A)

  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).

  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)

  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).

  Baseline (T0, pre-intervention); immediately after surgery in the postoperative recovery period (T2)]

• Subjective Anxiety: Amsterdam Preoperative Anxiety and Information Scale (APAIS)

  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).

  Baseline (T0, pre-intervention)

Secondary Outcomes (4)

• Heart Rate Variability (HRV)

  Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)

• Systolic Blood Pressure

  Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)

• Diastolic Blood Pressure

  Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)

• Heart Rate

  Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)

Study Arms (3)

Self-selected Music Group

EXPERIMENTAL

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.

Behavioral: Self-selected Music intervention

Fixed-music Group

ACTIVE COMPARATOR

Playing the same piece of classical music pre-selected by the research team.

Behavioral: Fixed-music Music intervention

No-music

NO INTERVENTION

Participants wore earmuff headphones and wearable physiological monitoring devices to measure HRV, with no music played during the process.

Interventions

Self-selected Music intervention BEHAVIORAL

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).

Self-selected Music Group

Fixed-music Music intervention BEHAVIORAL

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

Fixed-music Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Da-Yeh University: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 17, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share