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临床试验/CTRI/2024/03/063898
CTRI/2024/03/063898尚未招募3 期

Does perioperative Music and noise cancellation headphones reduce perception of Pain and Anxiety in patients undergoing paCEmaker implantation: Randomised control trial (M-PACE trial)

Christian Medical College1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
270
试验地点
1
主要终点
To compare the postoperative STAI-6 anxiety score between the study groups

研究概览

简要总结

Patients undergoing permanent pacemaker implantation are often anxious. Anxiety may lead to poor cooperation during the procedure, increased pain perception and increased blood pressure.1 Sedatives, anti-anxiety drugs and analgesics are administered in the perioperative period to reduce anxiety and pain. These medications have adverse side effects which can cause morbidity.

Nonpharmacological intervention such as administration of music has been found to have reduction in perioperative anxiety and perception of pain.2 Music therapy has no side effects and is inexpensive. It has been used as an adjunct to analgesics or antianxiety medications to reduce anxiety and pain. The data on music administration during pacemaker implantation under local anesthesia is sparse. There are only few studies which compared music therapy versus noise cancellation headphones on pain perception and anxiety in the perioperative period and these studies have shown contradictory results.3 Since the effect of noise cancellation headphones on anxiety and pain perception is not clearly known, it was decided to have three arms comparing 1) music vs 2)Noise cancellation headphones with no music vs 3) No music and no headphone.

This study is aimed at comparing the effects of music therapy via noise cancellation headphone (Group A) on anxiety and perception of pain in patients undergoing pacemakermplantation under local anaesthesia verses active noise cancellation headphones with no music (Group B) and no music and no headphone (Group C).

  1. Kain ZN, Sevarino F, Alexander GM, et al. Preoperative anxiety and postoperative pain in women undergoing hysterectomy. A repeated-measures design. J Psychosom Res 2000;49:417–22 2. Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev 2013;(6):Cd006908. 3. Ligree N, Nanda S, Morwal S, Garg K. Effect of binaural beat music and noise cancelling headphones on intraoperative anxiety in patients undergoing spinal anaesthesia – A randomised controlled study. Indian J Anaesth 2023;67:590-4.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing dual chamber pacemaker implantation under local anaesthesia.

排除标准

  • Hearing impairment, High baseline anxiety score and patient with known Psychiatric disorders like generalized anxiety disorders, depression, and bipolar disorders.

结局指标

主要结局

To compare the postoperative STAI-6 anxiety score between the study groups

时间窗: Baseline (preprocedure and 3 hours postprocedure)

次要结局

  • 1. To compare the postoperative pain score as measured by VAS between the study groups.(2. To compare the change in STAI-6 anxiety score (postprocedure and preprocedure) between the study groups.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anand Manickavasagam

Christian Medical College

研究点 (1)

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