Preoperative AnxietyNCT07902765
Music for Reducing Anxiety Before Surgery
A study testing music listening in people with Preoperative Anxiety, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- music listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteVietnam
- Study dates
- Dec 2026to Jun 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Scheduled for elective surgery at Thu Duc General Hospital
- American Society of Anesthesiologists (ASA) physical status I or II
- Alert and well oriented
- Able to read, understand, and communicate in Vietnamese
- Expected waiting time in the preoperative area of at least 40 minutes
- Agrees to participate and provides written informed consent
Who cannot join
- Hearing impairment or use of a hearing aid
- Psychiatric disorder, or currently treated with sedatives or antidepressants
- Skin lesions on the head or ear region, or acute ear infection
- Cognitive impairment, altered consciousness, or inability to complete the questionnaire independently
- Received premedication or sedatives before the 30-minute assessment (T1)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Thu Duc General Hospital
Ho Chi Minh City
Tuyet Trinh T Le, BSN, +84 932 162 074, trinhsunrise@gmail.com
About this study
Official title: Effectiveness of Music on Anxiety Levels in Patients Before Surgery: A Randomized Controlled Trial at Thu Duc General Hospital, Ho Chi Minh City
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.
Read more
Participants will:
- Complete the Vietnamese version of the STAI-Y1 questionnaire and have vital signs measured before the intervention
- Either listen to music they choose from a researcher-prepared playlist through over-ear headphones for 30 minutes, or wait in the preoperative waiting area under usual care for 30 minutes
- Complete the STAI-Y1 again and have vital signs measured 30 minutes after the start of the intervention
Read the detailed description
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.
- Conditions
- Preoperative Anxiety
- Being tested
- music listening
- Keywords
- music intervention, preoperative anxiety, STAI-Y1, preoperative care, perioperative nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music listeningBehavioural
Also called Music intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Music listening | Experimental | Participants listen to music through over-ear headphones for 30 minutes while waiting for elective surgery, in addition to usual care. Receives: Behavioral: music listening |
| Usual care | No intervention | Participants wait in the preoperative waiting area for 30 minutes under usual hospital care, without music. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before the intervention) and 30 minutes after the start of the intervention
Secondary outcomes (4)
Systolic Blood Pressure
Measured with a GE patient monitor, in mmHg.
Measured: Baseline (before the intervention) and 30 minutes after the start of the intervention
Diastolic Blood Pressure
Measured with a GE patient monitor, in mmHg.
Measured: 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.
Measured: Baseline (before the intervention) and 30 minutes after the start of the intervention
Respiratory Rate
Counted over one minute, in breaths per minute.
Measured: Baseline (before the intervention) and 30 minutes after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized controlled trial with 1:1 allocation. Participants are randomized to 30 minutes of music listening through headphones or 30 minutes of usual care in the preoperative waiting area. The allocation sequence uses permuted blocks of variable size (4 and 6).
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Collaborators
- Thu Duc General Hospital
- Responsible party
- Principal investigator, Le Thi Tuyet Trinh, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Tuyet Trinh T Le, BSN, Principal investigator, University of Medicine" rồi chọn University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902765
- Sponsor's protocol ID
- 62/CN-HDDD
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because participant consent covers use of data by the research team only.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Music on Anxiety Levels in Patients Before Surgery: A Randomized Controlled Trial at Thu Duc General Hospital, Ho Chi Minh City
- ClinicalTrials.gov ID
- NCT07902765
- Acronym / sponsor ID
- 62/CN-HDDD
- Conditions
- Preoperative Anxiety
- Keywords
- music intervention, preoperative anxiety, STAI-Y1, preoperative care, perioperative nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Thu Duc General Hospital
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Oct 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.
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:
- Complete the Vietnamese version of the STAI-Y1 questionnaire and have vital signs measured before the intervention
- Either listen to music they choose from a researcher-prepared playlist through over-ear headphones for 30 minutes, or wait in the preoperative waiting area under usual care for 30 minutes
- Complete the STAI-Y1 again and have vital signs measured 30 minutes after the start of the intervention
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial with 1:1 allocation. Participants are randomized to 30 minutes of music listening through headphones or 30 minutes of usual care in the preoperative waiting area. The allocation sequence uses permuted blocks of variable size (4 and 6).
| Arm | Type | Receives |
|---|---|---|
| Music listening | Experimental | Behavioral: music listeningParticipants listen to music through over-ear headphones for 30 minutes while waiting for elective surgery, in addition to usual care. |
| Usual care | No intervention | –Participants wait in the preoperative waiting area for 30 minutes under usual hospital care, without music. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older
- Scheduled for elective surgery at Thu Duc General Hospital
- American Society of Anesthesiologists (ASA) physical status I or II
- Alert and well oriented
- Able to read, understand, and communicate in Vietnamese
Key exclusion criteria (5 listed)
- Hearing impairment or use of a hearing aid
- Psychiatric disorder, or currently treated with sedatives or antidepressants
- Skin lesions on the head or ear region, or acute ear infection
- Cognitive impairment, altered consciousness, or inability to complete the questionnaire independently
- Received premedication or sedatives before the 30-minute assessment (T1)
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 |
|---|---|---|
| music listeningAlso: Music interventionParticipants 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. | Behavioural | Music listening |
Primary outcome
State Anxiety Score (STAI-Y1)
Time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention
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.
4 secondary outcomes
Systolic Blood Pressure
Time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention
Diastolic Blood Pressure
Time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention
Heart Rate
Time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention
Respiratory Rate
Time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention
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 29 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because participant consent covers use of data by the research team only.
Related trials for Preoperative Anxiety
Not yet recruiting
Effect of Animation-Assisted Preoperative Information on Anxiety in Adolescents: A Multicenter Randomized Controlled Trial
Preoperative Anxiety
Recruiting
Evaluating Operation Calm With Children, Parents, and Clinicians
Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
RecruitingObservational study
Evaluation of Preoperative Anxiety in Digestive Surgery
Digestive System Neoplasms, Anxiety
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Not yet recruitingObservational study
Preoperative Fasting and Perioperative Outcomes in Children Undergoing Elective Circumcision
Preoperative Fasting, Perioperative Anxiety
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.
Tuyet Trinh T Le, BSN principal investigator
University of Medicine" rồi chọn University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music listening in people with Preoperative Anxiety, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 7 inclusion and 5 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Tuyet Trinh T Le, BSN (+84 932 162 074, trinhsunrise@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Score (STAI-Y1) (time frame: Baseline (before the intervention) and 30 minutes after the start of the intervention). 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 29 Oct 2026.