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临床试验/CTRI/2019/11/022112
CTRI/2019/11/022112招募中不适用

Effect of music on pain, anxiety and physiological parameters among postoperative sternotomy patients- A Randomized Controlled Trial.

PrabuG1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Music may reduce the post operative pain measured by numerical pain rating scale among sternotomy patients through the music

研究概览

简要总结

This study is a randomized controlled trial to know the effect of music on post operative pain ,anxiety and physiological parameters among post operative sternotomy patients who are over eighteen years, first time , elective sternotomy patients with stable hemo-dynamics , able to follow the verbal orders with willing to participate. patients who are continious infusion of sedatives or analgesic after 6 to 8 hours of surgery and with hearing problems.informed consent  will be obtained pre-operatively and sample are selected by block randomisation  with sample size of 70( 35 in each of study and control group) and the after the first day of surgery both study and control group will be asseded for pain ,anxiety, physiological parameters before the intervention. the study group will be provided with preferred music by the patient for 15-20 minutes for four times in a day at four hours interval at the convience of patients and staffs using noise cancellation headphones.In control group ,will be provided with only noise cancellation headphones without music for same duration and frequency as mentioned above. Measurement of post operative pain, anxiety and  physiological parameters  after the intervention is measured after seven days of intervention .This study will be conducted in CTVS ICU , super speciality block, first floor, JIPMER ,Puducherry.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •Patient’s age over eighteen years with Elective and first time sternotomy patients who recovered from anesthesia and weaned off from ventilator with the signs of stable hemodynamic with the Ability to follow verbal orders and Patients who are willing to participate in the study before the surgery ,in pre operative period.

排除标准

  • •Patient on continuous infusion of sedatives and analgesic and muscle relaxants drugs after 6 to 8 hours after surgery, patients with hearing problems and Patients on or has cardiopulmonary resuscitation procedure done in operating room or postoperative ICU.

结局指标

主要结局

Music may reduce the post operative pain measured by numerical pain rating scale among sternotomy patients through the music

时间窗: 7 days

次要结局

  • Music may also has effect to reduce the anxietyive anxiety scale measured by post operat and stabilizing the physiological parameters of post operative pain among sternotomy patients.(7 days)

研究者

发起方
PrabuG
申办方类型
Other [(self)]

研究点 (1)

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