Individualized Music Versus Propofol for Perioperative Anxiety During Regional Anaesthesia

September 10, 2026 updated by: University of Malaya

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Federal Territory of Kuala L
      • Kuala Lumpur, Federal Territory of Kuala L, Malaysia, 59100
        • University Malaya Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Received general anaesthesia.
  • Refused to participate.
  • Hearing impairment.
  • Diagnosed neurocognitive or psychiatric disorder.
  • Aggressive or uncooperative behaviour.
  • Surgery duration exceeding 3 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Professionally Prescribed Individualized Music
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.
Behavioral: Professionally Prescribed Individualized Music
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.
Active Comparator: Intravenous Propofol Sedation
Participants received intravenous propofol sedation during surgery under regional anaesthesia using target-controlled infusion. Propofol was titrated according to clinical assessment and sedation monitoring.
Drug: propofol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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.
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.
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.
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.
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.
Systolic blood pressure was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
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
Diastolic blood pressure was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
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
Heart rate was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
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
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.
Postoperative period: During assessment in the post-anaesthesia recovery room, on the same day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: MOHD FITRY BIN ZAINAL ABIDIN, University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2023

Primary Completion (Actual)

March 13, 2024

Study Completion (Actual)

March 13, 2024

Study Registration Dates

First Submitted

September 4, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 15, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023418-12366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is currently no plan to make individual participant data publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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