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COMPLETED
NCT07820787
NA

Individualized Music Versus Propofol for Perioperative Anxiety During Regional Anaesthesia

Sponsor: University of Malaya

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-08-07

Completion Date

2024-03-13

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

University Malaya Medical Centre

Kuala Lumpur, Federal Territory of Kuala L, Malaysia