An interventional study of music listening in Preoperative Anxiety, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Not yet recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to learn whether listening to self-selected music through headphones for 30 minutes before surgery lowers state anxiety in adults waiting for elective surgery.
The main question it aims to answer is: Do adults (ASA physical status I-II) who listen to music for 30 minutes in the preoperative waiting area have lower state anxiety scores (STAI-Y1) than adults who receive usual care? Researchers will compare a music group with a usual-care group to see whether state anxiety, blood pressure, heart rate, and respiratory rate differ after 30 minutes.
Participants will:
Design: Single-center, parallel-group, randomized controlled trial with 1:1 allocation, conducted at the Department of Anesthesiology and Critical Care, Thu Duc General Hospital, Ho Chi Minh City, Vietnam. The protocol follows SPIRIT 2025 and results will be reported according to CONSORT 2025.
Screening: Each evening, the investigator screens the next day's elective surgery list against the eligibility criteria. Eligible patients are stratified by type of surgery and randomly selected within each stratum using the RAND() function in Microsoft Excel. Selected patients are approached in the preoperative area after admission procedures are completed. Written informed consent is obtained before allocation.
Randomization and allocation concealment: The allocation sequence is computer-generated by an independent researcher who is not involved in recruitment, using permuted blocks of variable size (4 and 6). Allocations are placed in identical, sealed, sequentially numbered envelopes, opened in order only after consent is signed.
Masking: Participants and investigators are not masked because of the nature of the intervention. Anxiety is measured with a standardized self-report scale.
Intervention: Participants in the music group choose tracks from a researcher-prepared playlist (classical, nature sounds, meditation, Catholic religious music, and therapeutic music; tempo 60-80 beats per minute; volume about 50 to below 60 dB) played from an iPhone or Samsung Galaxy Tab S6 Lite through Sony WH-CH520 over-ear headphones for 30 minutes. The playlist was developed from criteria reported in previous studies and a preliminary survey of patients' music listening habits and preferences. Single-use protective covers are used for each patient and headphones are disinfected after each use.
Control: Participants in the control group wait in the preoperative waiting area for 30 minutes under usual hospital care.
Measurements: State anxiety (STAI-Y1, Vietnamese version, licensed from Mind Garden, Inc.) and vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, SpO2, measured with a GE patient monitor) are recorded at baseline (T0) and 30 minutes after the start of the intervention (T1). Demographic and surgical characteristics are recorded at baseline.
Sample size: Based on a previous study, with alpha = 0.05 and power = 80%, 41 participants per group are required. Allowing for 10% attrition, 92 participants (46 per group) will be enrolled.
Analysis: Data will be analyzed with Stata 17.
University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants listen to music through over-ear headphones for 30 minutes while waiting for elective surgery, in addition to usual care.
Behavioral: music listening
Participants wait in the preoperative waiting area for 30 minutes under usual hospital care, without music.
Participants choose tracks from a researcher-prepared playlist (classical, nature sounds, meditation, Catholic religious music, and therapeutic music; tempo 60-80 beats per minute) and listen through Sony WH-CH520 over-ear headphones at about 50 to below 60 dB for 30 minutes before surgery.
Also known as: Music intervention
State Anxiety Score (STAI-Y1)
State anxiety measured with the Vietnamese version of the State-Trait Anxiety Inventory, Form Y-1 (20 items, 4-point scale). Total score ranges from 20 to 80; higher scores indicate greater anxiety. The score at 30 minutes is compared between groups, adjusted for the baseline score.
Time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention
Systolic Blood Pressure
Measured with a GE patient monitor, in mmHg.
Time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention
Diastolic Blood Pressure
Measured with a GE patient monitor, in mmHg.
Time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention
Heart Rate
Measured with a GE patient monitor, in beats per minute.
Time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention
Respiratory Rate
Counted over one minute, in breaths per minute.
Time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention
Plan to share: No — Individual participant data will not be shared because participant consent covers use of data by the research team only.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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