Perioperative AnxietyNCT07820787
Individualized Music Versus Propofol for Perioperative Anxiety During Regional Anaesthesia
A study testing Professionally Prescribed Individualized Music and propofol in people with Perioperative Anxiety, run by University of Malaya at 1 site in Malaysia.
Trial summary
Perioperative anxiety is common among patients undergoing surgery under regional anaesthesia. Intravenous sedative-hypnotic agents such as propofol are commonly administered to reduce anxiety and improve patient comfort; however, pharmacological sedation may reduce patient alertness and cause cardiorespiratory adverse… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perioperative Anxiety
- What is being tested?
- Professionally Prescribed Individualized Music and propofol
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 7 Aug 2023to 13 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- No sedative or anxiolytic medication received before surgery that could affect measurement of vital signs or Bispectral Index (BIS).
- Able to understand and communicate in Malay or English, understand the purpose and objectives of the study, and provide written informed consent.
- Surgery planned under regional anaesthesia (spinal, epidural, or peripheral nerve block).
- Surgery performed in the supine position.
Who cannot join
- Received general anaesthesia.
- Refused to participate.
- Hearing impairment.
- Diagnosed neurocognitive or psychiatric disorder.
- Aggressive or uncooperative behaviour.
- Surgery duration exceeding 3 hours.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Federal Territory of Kuala L, 59100
About this study
Official title: Comparing Professionally-prescribed Music by Music Therapist Versus Standard Practice Using Intravenous Sedative-hypnotic Agents on the Anxiolytic and Sedative Effect During Regional Anaesthesia: A Randomized Controlled Trial
Perioperative anxiety is common among patients undergoing surgery under regional anaesthesia. Intravenous sedative-hypnotic agents such as propofol are commonly administered to reduce anxiety and improve patient comfort; however, pharmacological sedation may reduce patient alertness and cause cardiorespiratory adverse effects. Music may provide a non-pharmacological alternative for reducing perioperative anxiety.
This prospective controlled study compared professionally prescribed individualized music with intravenous propofol sedation in adult patients undergoing surgery under regional anaesthesia. Participants in the music group received an individualized playlist curated by a professional music therapist following assessment of their music preferences and listening history. Participants in the sedative-hypnotic group received intravenous propofol sedation titrated according to clinical assessment.
Perioperative anxiety was assessed before and after surgery using the State-Trait Anxiety Inventory-State (STAI-S) and a visual analogue scale (VAS). Intraoperative sedation and alertness were assessed using the Bispectral Index (BIS) and Modified Observer's Assessment of Alertness/Sedation (mOAA/S), together with haemodynamic monitoring and patient satisfaction.
Read the detailed description
This was a prospective, single-centre, parallel-group controlled study conducted at University Malaya Medical Centre, Kuala Lumpur, Malaysia. Adult patients scheduled for surgery under regional anaesthesia were allocated to either a music-therapy group or a sedative-hypnotic group according to their scheduled operating day.
Participants assigned to the music intervention underwent a preoperative assessment by a professional music therapist. The assessment included the participant's music-listening history and preferences, following which an individualized playlist was curated for intraoperative listening through headphones.
Participants assigned to the sedative-hypnotic group received intravenous propofol using target-controlled infusion, titrated according to clinical assessment and sedation monitoring.
Anxiety was evaluated preoperatively and postoperatively using STAI-S and an anxiety VAS. Intraoperative BIS, mOAA/S, haemodynamic variables and relevant rescue interventions were recorded. Postoperative patient satisfaction was also assessed.
The study received approval from the Medical Research Ethics Committee, University Malaya Medical Centre (MREC ID 2023418-12366), before participant recruitment, and written informed consent was obtained from all participants. The study was completed before registration on ClinicalTrials.gov.
- Conditions
- Perioperative Anxiety
- Being tested
- Professionally Prescribed Individualized Music, propofol
- Keywords
- Individualized Music, Music Therapy, Perioperative Anxiety, Regional Anesthesia, Propofol, Sedation, Bispectral Index, State-Trait Anxiety Inventory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professionally Prescribed Individualized MusicBehavioural
Participants underwent a preoperative music assessment by a professional music therapist that included music-listening history and individual preferences. Based on this assessment, the music therapist curated an individualized playlist for each participant. The prescribed music was delivered intraoperatively through headphones during surgery under regional anaesthesia. Participants remained awake without routine intravenous sedation, although rescue sedation could be administered when clinically required.
propofolDrug
Participants received intravenous propofol sedation by target-controlled infusion during surgery under regional anaesthesia. Sedation was titrated according to clinical assessment using Bispectral Index (BIS) and Modified Observer's Assessment of Alertness/Sedation (mOAA/S) monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Professionally Prescribed Individualized Music | Experimental | Participants received professionally prescribed individualized music during surgery under regional anaesthesia. Before surgery, a professional music therapist assessed each participant's music-listening history and preferences and curated an individualized playlist. Music was delivered intraoperatively through headphones. Rescue intravenous sedation could be administered when clinically required. Receives: Behavioral: Professionally Prescribed Individualized Music |
| Intravenous Propofol Sedation | Active comparator | Participants received intravenous propofol sedation during surgery under regional anaesthesia using target-controlled infusion. Propofol was titrated according to clinical assessment and sedation monitoring. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)
State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State (STAI-S) before and after surgery. The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. The outcome was the change in STAI-S score from the preoperative to the postoperative assessment.
Measured: Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery
Secondary outcomes (7)
Change in Anxiety Visual Analogue Scale (VAS) Score
Anxiety was assessed using a Visual Analogue Scale (VAS) ranging from 1 (least anxious) to 10 (most anxious), with higher scores indicating greater anxiety. The outcome was the change in VAS score from the preoperative to the postoperative assessment.
Measured: Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery
Intraoperative Bispectral Index (BIS)
Depth of sedation was assessed using the Bispectral Index (BIS). BIS values were recorded at 10-minute intervals during surgery to assess the level of sedation during the assigned intervention.
Measured: Every 10 minutes from the start of surgery until completion of surgery.
Intraoperative Level of Sedation Measured by Modified Observer's Assessment of Alertness/Sedation (mOAA/S)
Alertness and sedation were assessed using the modified Observer's Assessment of Alertness/Sedation (mOAA/S) scale, ranging from 0 to 5. A score of 5 indicates that the participant is alert and responds readily to their name spoken in a normal tone, whereas a score of 0 indicates no response to a painful trapezius squeeze. Higher scores therefore indicate greater alertness and lower levels of sedation. mOAA/S was assessed at 10-minute intervals during surgery.
Measured: Every 10 minutes from the start of surgery until completion of surgery.
Intraoperative Systolic Blood Pressure
Systolic blood pressure was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
Measured: Every 10 minutes from the start of surgery until completion of surgery.
Intraoperative Diastolic Blood Pressure
Diastolic blood pressure was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
Measured: Every 10 minutes from the start of surgery until completion of surgery
Intraoperative Heart Rate
Heart rate was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
Measured: Every 10 minutes from the start of surgery until completion of surgery
Postoperative Patient Satisfaction
Overall satisfaction with the intervention provided during surgery was assessed using a verbal numerical rating scale ranging from 1 (least satisfied) to 10 (most satisfied), with higher scores indicating greater satisfaction.
Measured: Postoperative period: During assessment in the post-anaesthesia recovery room, on the same day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start7 Aug 2023
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative AnxietyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to one of two parallel intervention groups according to the scheduled day of surgery. Participants scheduled on Tuesday or Thursday received intravenous propofol sedation, while participants scheduled on Wednesday or Friday received professionally prescribed individualized music.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MOHD FITRY BIN ZAINAL ABIDIN, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820787
- Sponsor's protocol ID
- 2023418-12366
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make individual participant data publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Professionally-prescribed Music by Music Therapist Versus Standard Practice Using Intravenous Sedative-hypnotic Agents on the Anxiolytic and Sedative Effect During Regional Anaesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07820787
- Acronym / sponsor ID
- 2023418-12366
- Conditions
- Perioperative Anxiety
- Keywords
- Individualized Music, Music Therapy, Perioperative Anxiety, Regional Anesthesia, Propofol, Sedation, Bispectral Index, State-Trait Anxiety Inventory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 15 Sep 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.
Perioperative anxiety is common among patients undergoing surgery under regional anaesthesia. Intravenous sedative-hypnotic agents such as propofol are commonly administered to reduce anxiety and improve patient comfort; however, pharmacological sedation may reduce patient alertness and cause cardiorespiratory adverse effects. Music may provide a non-pharmacological alternative for reducing perioperative anxiety.
This prospective controlled study compared professionally prescribed individualized music with intravenous propofol sedation in adult patients undergoing surgery under regional anaesthesia. Participants in the music group received an individualized playlist curated by a professional music therapist following assessment of their music preferences and listening history. Participants in the sedative-hypnotic group received intravenous propofol sedation titrated according to clinical assessment.
Perioperative anxiety was assessed before and after surgery using the State-Trait Anxiety Inventory-State (STAI-S) and a visual analogue scale (VAS). Intraoperative sedation and alertness were assessed using the Bispectral Index (BIS) and Modified Observer's Assessment of Alertness/Sedation (mOAA/S), together with haemodynamic monitoring and patient satisfaction.
Detailed description
This was a prospective, single-centre, parallel-group controlled study conducted at University Malaya Medical Centre, Kuala Lumpur, Malaysia. Adult patients scheduled for surgery under regional anaesthesia were allocated to either a music-therapy group or a sedative-hypnotic group according to their scheduled operating day.
Participants assigned to the music intervention underwent a preoperative assessment by a professional music therapist. The assessment included the participant's music-listening history and preferences, following which an individualized playlist was curated for intraoperative listening through headphones.
Participants assigned to the sedative-hypnotic group received intravenous propofol using target-controlled infusion, titrated according to clinical assessment and sedation monitoring.
Anxiety was evaluated preoperatively and postoperatively using STAI-S and an anxiety VAS. Intraoperative BIS, mOAA/S, haemodynamic variables and relevant rescue interventions were recorded. Postoperative patient satisfaction was also assessed.
The study received approval from the Medical Research Ethics Committee, University Malaya Medical Centre (MREC ID 2023418-12366), before participant recruitment, and written informed consent was obtained from all participants. The study was completed before registration on ClinicalTrials.gov.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel intervention groups according to the scheduled day of surgery. Participants scheduled on Tuesday or Thursday received intravenous propofol sedation, while participants scheduled on Wednesday or Friday received professionally prescribed individualized music.
| Arm | Type | Receives |
|---|---|---|
| Professionally Prescribed Individualized Music | Experimental | Behavioral: Professionally Prescribed Individualized MusicParticipants received professionally prescribed individualized music during surgery under regional anaesthesia. Before surgery, a professional music therapist assessed each participant's music-listening history and preferences and curated an individualized playlist. Music was delivered intraoperatively through headphones. Rescue intravenous sedation could be administered when clinically required. |
| Intravenous Propofol Sedation | Active comparator | Drug: propofolParticipants received intravenous propofol sedation during surgery under regional anaesthesia using target-controlled infusion. Propofol was titrated according to clinical assessment and sedation monitoring. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 70 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- No sedative or anxiolytic medication received before surgery that could affect measurement of vital signs or Bispectral Index (BIS).
- Able to understand and communicate in Malay or English, understand the purpose and objectives of the study, and provide written informed consent.
- Surgery planned under regional anaesthesia (spinal, epidural, or peripheral nerve block).
Key exclusion criteria (6 listed)
- Received general anaesthesia.
- Refused to participate.
- Hearing impairment.
- Diagnosed neurocognitive or psychiatric disorder.
- Aggressive or uncooperative behaviour.
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 |
|---|---|---|
| Professionally Prescribed Individualized MusicParticipants underwent a preoperative music assessment by a professional music therapist that included music-listening history and individual preferences. Based on this assessment, the music therapist curated an individualized playlist for each participant. The prescribed music was delivered intraoperatively through headphones during surgery under regional anaesthesia. Participants remained awake without routine intravenous sedation, although rescue sedation could be administered when clinically required. | Behavioural | Professionally Prescribed Individualized Music |
| propofolParticipants received intravenous propofol sedation by target-controlled infusion during surgery under regional anaesthesia. Sedation was titrated according to clinical assessment using Bispectral Index (BIS) and Modified Observer's Assessment of Alertness/Sedation (mOAA/S) monitoring. | Drug | Intravenous Propofol Sedation |
Primary outcome
Change in State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)
Time frame: Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery
State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State (STAI-S) before and after surgery. The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. The outcome was the change in STAI-S score from the preoperative to the postoperative assessment.
7 secondary outcomes
Change in Anxiety Visual Analogue Scale (VAS) Score
Time frame: Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery
Intraoperative Bispectral Index (BIS)
Time frame: Every 10 minutes from the start of surgery until completion of surgery.
Intraoperative Level of Sedation Measured by Modified Observer's Assessment of Alertness/Sedation (mOAA/S)
Time frame: Every 10 minutes from the start of surgery until completion of surgery.
Intraoperative Systolic Blood Pressure
Time frame: Every 10 minutes from the start of surgery until completion of surgery.
Intraoperative Diastolic Blood Pressure
Time frame: Every 10 minutes from the start of surgery until completion of surgery
Intraoperative Heart Rate
Time frame: Every 10 minutes from the start of surgery until completion of surgery
Postoperative Patient Satisfaction
Time frame: Postoperative period: During assessment in the post-anaesthesia recovery room, on the same day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data publicly available.
Related trials for Perioperative Anxiety
Recruiting
Perioperative Meditation Music Intervention in Patients With Type 2 Diabetes Undergoing Elective Surgery
Diabetes Type 2
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 recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Not yet recruiting
Music for Reducing Anxiety Before Surgery
Preoperative Anxiety
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
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. This study is not recruiting at the moment.
MOHD FITRY BIN ZAINAL ABIDIN principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professionally Prescribed Individualized Music and propofol in people with Perioperative Anxiety, run by University of Malaya at 1 site in Malaysia.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 15 Sep 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S) (time frame: Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery). 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 15 Sep 2026.