AnxietyNCT07476820
Anxiety and Physiological Responses in Ambulatory Surgery
A study testing Self-selected Music intervention and Fixed-music Music intervention in people with Anxiety and Heart Rate Variability (HRV), run by Da-Yeh University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Heart Rate Variability (HRV), Heart Rate
- What is being tested?
- Self-selected Music intervention and Fixed-music Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Subjective Anxiety and Physiological Parameters in First-Time Ambulatory Surgery Patients
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.
Read the 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.
- Conditions
- Anxiety, Heart Rate Variability (HRV), Heart Rate, Blood Pressure
- Being tested
- Self-selected Music intervention, Fixed-music Music intervention
- Keywords
- Music, Anxiety, Ambulatory Surgery, Physiological Indicators
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-selected Music interventionBehavioural
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 interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-selected Music intervention |
| Fixed-music Group | Active comparator | Playing the same piece of classical music pre-selected by the research team. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Baseline (T0, pre-intervention)
Secondary outcomes (4)
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.
Measured: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)
Systolic Blood Pressure
Systolic blood pressure will be recorded using a wrist-worn physiological monitor (Heart Rhythm Master).
Measured: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)
Diastolic Blood Pressure
Diastolic blood pressure will be recorded using a wrist-worn physiological monitor (Heart Rhythm Master).
Measured: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)
Heart Rate
Heart rate will be recorded using a wrist-worn physiological monitor (Heart Rhythm Master).
Measured: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start23 Feb 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Da-Yeh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-chen Wu, Da-Yeh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476820
- Sponsor's protocol ID
- 115011
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Anxiety and Physiological Parameters in First-Time Ambulatory Surgery Patients
- ClinicalTrials.gov ID
- NCT07476820
- Acronym / sponsor ID
- 115011
- Conditions
- Anxiety, Heart Rate Variability (HRV), Heart Rate, Blood Pressure
- Keywords
- Music, Anxiety, Ambulatory Surgery, Physiological Indicators
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Da-Yeh UniversityUniversity, hospital or other
- Study start
- 23 Feb 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-selected Music Group | Experimental | Behavioral: Self-selected Music interventionParticipants 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. |
| Fixed-music Group | Active comparator | Behavioral: Fixed-music Music interventionPlaying the same piece of classical music pre-selected by the research team. |
| No-music | No intervention | –Participants wore earmuff headphones and wearable physiological monitoring devices to measure HRV, with no music played during the process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-selected Music interventionThis 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). | Behavioural | Self-selected Music Group |
| Fixed-music Music interventionParticipants 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 | Behavioural | Fixed-music Group |
Primary outcome
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 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).
Subjective Anxiety: State Anxiety Inventory (STAI-S)
Time frame: Baseline (T0, pre-intervention); immediately after surgery in the postoperative recovery period (T2)]
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).
Subjective Anxiety: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: Baseline (T0, pre-intervention)
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).
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Self-selected Music intervention and Fixed-music Music intervention in people with Anxiety and Heart Rate Variability (HRV), run by Da-Yeh University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.