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Anxiety and Physiological Responses in Ambulatory Surgery

ConditionsAnxietyHeart Rate Variability (HRV)Heart RateBlood Pressure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDa-Yeh University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Self-selected Music GroupExperimental treatment 1 intervention
Group B: Fixed-music GroupActive comparator 1 intervention
Group C: No-musicNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline (T0, pre-intervention); during the 10-minute intervention (T1); immediately after surgery in the postoperative recovery period (T2)]
2

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).

Time frame
Baseline (T0, pre-intervention); immediately after surgery in the postoperative recovery period (T2)]
3

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).

Time frame
Baseline (T0, pre-intervention)

Secondary outcomes

1

Heart Rate Variability (HRV)

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.

Time frame
Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)
2

Systolic Blood Pressure

Systolic blood pressure will be recorded using a wrist-worn physiological monitor (Heart Rhythm Master).

Time frame
Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)
3

Diastolic Blood Pressure

Diastolic blood pressure will be recorded using a wrist-worn physiological monitor (Heart Rhythm Master).

Time frame
Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)
4

Heart Rate

Heart rate will be recorded using a wrist-worn physiological monitor (Heart Rhythm Master).

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Da-Yeh University

Lead sponsor

Source ClinicalTrials.gov

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