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Completed

NCT Number: NCT07820787

Individualized Music Versus Propofol for Perioperative Anxiety During Regional Anaesthesia

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.

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Key information

Conditions

Perioperative Anxiety

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre

Kuala Lumpur, Federal Territory of Kuala L, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Professionally Prescribed Individualized Music

Behavioral

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.

Propofol

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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