Effect of Music Therapy on the Quality of Recovery

NCT06874972 | Completed

• 1 other identifier: Music for recovery
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The use of music in operations is increasing due to its painless, safe, inexpensive, and the potential to improve patient outcomes. Objective: We aimed to evaluate the effects of music therapy on the quality of awakening and recovery of patients who underwent elective laparoscopic cholecystectomy under general anesthesia, and to compare the perioperative pain and anxiety related to surgery. Methods: This double-blinded randomized clinical trial was conducted at the National Referral Hospital, Bhutan from 1st November 2022 to 31st October 2023. Those patients who underwent laparoscopic cholecystectomy under general anesthesia were included in the clinical trial. Web-based simple randomization was performed, and all those patients with even numbers were allocated to the study group and odd numbers in the control group. During the perioperative period, music was played using headphones in the study group, and empty headphone was placed in the control group. Hemodynamic parameters, quality of awakening (measured using the Riker sedation-agitation scale), and recovery (measured using a 40-item questionnaire, QoR-40) were recorded using a questionnaire developed for the study. Perioperative anxiety and pain were compared between the study group using a Visual analog scale (VAS).

Conditions

Music Therapy; Music Therapy for Pain and Sedation; Postoperative Period; Perioperative Period; Visual Analog Scale

Keywords

music therapy

Outcome Measures

Primary Outcomes (2)

• Quality of awakening

  To compare the quality of awakening from surgery and anesthesia between study and control group using Riker sedation-agitation scale

  12 months

• Quality of recovery from surgery and anesthesia

  To compare qaulity of recovery from surgery and anesthesia between study and control group using Riker sedation-agitation scale

  12 months

Secondary Outcomes (1)

• Postoperative pain score

  12 months

Study Arms (2)

Study group (Music group)

EXPERIMENTAL

Music is played to the study group (music group)

Device: Music played

Control group (no music played)

NO INTERVENTION

No music is played in the control group

Interventions

Music played DEVICE

Music is played in the study group, and no music is played in the control group.

Study group (Music group)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing laparoscopic cholecystectomy under general anesthesia
• Patients with American Society of Anesthesiologists (ASA) Grade I and II

You may not qualify if:

• Patients with ASA III or more
• Patients with hearing or cognitive impairment
• Patients with ear infections (acute or chronic suppurative otitis media) and with recent ear surgery
• Patients on long-term steroid therapy
• Patients with drug or alcohol abuse history
• Patients who are unable to cooperate (due to dementia and mental retardation)

Sponsors & Collaborators

• Ministry of Health, Bhutan: lead

Study Sites (1)

Phuentsholing Hospital

Phuentsholing, 21001, Bhutan

Location

Study Officials

• Yeshey Dorjey

  Phuentsholing General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of music therapy on the quality of recovery in patients undergoing laparoscopic cholecystectomy under general anesthesia, at the national referral hospital, Bhutan: a randomized controlled trial

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 13, 2025
• Study Start: November 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

BH (1)