Individualized Music Versus Propofol for Perioperative Anxiety During Regional Anaesthesia

NCT07820787 | Completed

• 1 other identifier: 2023418-12366
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Perioperative Anxiety

Keywords

Individualized Music; Music Therapy; Perioperative Anxiety; Regional Anesthesia; Propofol; Sedation; Bispectral Index; State-Trait Anxiety Inventory

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  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)

  Every 10 minutes from the start of surgery until completion of surgery.

• Intraoperative Systolic Blood Pressure

  Every 10 minutes from the start of surgery until completion of surgery.

• Intraoperative Diastolic Blood Pressure

  Every 10 minutes from the start of surgery until completion of surgery

Study Arms (2)

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.

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.

Drug: propofol

Interventions

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.

Professionally Prescribed Individualized Music

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.

Intravenous Propofol Sedation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

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

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• MOHD FITRY BIN ZAINAL ABIDIN

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and investigators administering the interventions were not masked because of the nature of the interventions. Postoperative outcome assessment was performed by a research assistant who was blinded to group allocation. The statistician conducting the original analysis was also blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 15, 2026
• Study Start: August 7, 2023
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)