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临床试验/NCT06874972
NCT06874972已完成不适用

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

Ministry of Health, Bhutan1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Quality of awakening

研究概览

简要总结

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).

详细描述

INTRODUCTION Music is a structured combination of sound with recognizable melody and rhythm, that is pleasant or exciting to listen to. Music causes body and mind relaxation, improves mood, reduces stress, and improves memory.

Music modulates the release of neurotransmitters in the brain. Musical stimuli increase extracellular levels of dopamine and serotonin and have pleasant effects on the body and mind.

Due to its pleasant effects on the body and mind, music has been used as a therapy in the medical field. Music therapy is found to significantly decrease pain, improve emotional distress from pain, reduce anesthetic agents and opioid use, and improve heart rate, blood pressure, and saturation during surgical procedures.

Music is usually played in the operating theatres. Music has an impact on the operating teams. Few surgeons and operating teams have regarded music as a distraction to their task, however, the positive impact of music on the surgical performance of the surgeons and the operating teams and the surgical outcomes was reported significantly more compared to the negative impact.

Patients prefer to listen to different music depending on their likes during the perioperative period. Music is found to have a positive impact on patients waiting for surgery by reducing stress, anxiety, and depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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)

研究组 & 干预措施

Study group (Music group)

Experimental

Music is played to the study group (music group)

干预措施: Music played (Device)

Control group (no music played)

No Intervention

No music is played in the control group

结局指标

主要结局

Quality of awakening

时间窗: 12 months

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

Quality of recovery from surgery and anesthesia

时间窗: 12 months

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

次要结局

  • Postoperative pain score(12 months)

研究者

发起方
Ministry of Health, Bhutan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yeshey Dorjey

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

Ministry of Health, Bhutan

研究点 (1)

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