跳至主要内容
临床试验/CTRI/2024/07/070563
CTRI/2024/07/070563尚未招募Phase 3 4

Effect of music therapy on pain and anxiety in adult patients undergoing cardiac surgery through midline sternotomy

Vardhaman Mahavir Medical College and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月30日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To study the effect of music therapy on postoperative pain score at 2hours, 1 2 hours and 24

研究概览

简要总结

In recent times music therapy is used as one among the various non-opioid based therapeutic which is often used as a non pharmacological supplement. Here we are going to study the effect of music therapy in reducing post operative pain and anxiety in patients undergoing cardiac surgery through midline sternotomy.The methodology will be after explaining about the study and getting informed consent the subjects will be divided into two groups (group - M music therapy group -C control ) using computer generated random tables then 20 minutes music therapy will be given to M group subjects in the pre op and 2,12,24 hours post extubation and no intervention will be done for  C group subjects. Pain and STAI anxiety score will be assessed after every session. We hypothesize that the music therapy will reduce pain and anxiety in patients undergoing cardiac surgery through midline sternotomy.we are also assessing quality of sleep in the postoperative period.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients fulfilling the criteria of American Society of Anaesthesiologists (ASA) Grade II and III, aged between 18-65 years posted for elective cardiac surgery necessitating midline sternotomy.

排除标准

  • Inability to communicate effectively/ psychiatric illness
  • Patients who are expected to remain intubated for more than 24 hours post surgery.

结局指标

主要结局

To study the effect of music therapy on postoperative pain score at 2hours, 1 2 hours and 24

时间窗: 20 minutes of music therapy will be provided each time before assessing the pain score

hours post extubation in patients undergoing cardiac surgery through midline sternotomy

时间窗: 20 minutes of music therapy will be provided each time before assessing the pain score

次要结局

  • To study the effect of music therapy on:(• Pre induction anxiety score (after music therapy))

研究者

发起方
Vardhaman Mahavir Medical College and Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ashwanth G

VMMC and Safdarjung hospital

研究点 (1)

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