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临床试验/CTRI/2024/09/073805
CTRI/2024/09/073805尚未招募不适用

Effect of musical therapy on hemodynamic parameters and inflammatory markers in patients undergoing surgery for varicose veins under spinalanaesthesia

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
to analyse the effectiveness of music therapy on hemodynamic parameters and inflammatorey markers in patient undergoing varicose vein surgery under spinal anaesthesia.

研究概览

简要总结

after inclusion computer generated randomization will devide patients into two groups control group and music intervention group which will be made to listen music by noise cancelling headphones with the volume lebel as acceptable by patient ,for 1 hour duration of surgery.where as control group patient surgery will be begun without any music intervention after onset of effect of subarachnoid block. there is 3 blood samples will be taken for study of inflammatory markers subsequentely before during and after varicose vien surgery.approximately 1 hour before the start of surgery in preop room participant will fill state trait anxiety inventory for state anxiety score .after taking the patient in operation room standeaed monitoring will be attached and vitals parameters will be assessed initially every 5 minutes for first 30 minute then every 10 minutes till 60 minutes and subsequently every 15 minutes till end of surgery.patient satisfaction score noted at thr end of 4 hours of surgery using patient satisfaction score .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • .All patient of either sex aged above 16 years undergoing varicose vein surgery under spinal anaesthesia.

排除标准

  • .patients not willing to particepate in the study.
  • .contraindication for neuraxial anaesthesia.
  • .having hearing and visual impairement.
  • .patients with active infection or open wound of the face or eye ,ear area.
  • .having chronic pain syndrome.
  • .having mental or psychiatric disorders.
  • .patient with CAD and DM.

结局指标

主要结局

to analyse the effectiveness of music therapy on hemodynamic parameters and inflammatorey markers in patient undergoing varicose vein surgery under spinal anaesthesia.

时间窗: After taking patient in operating room baseline hemodynamic parameters will be assessed then every 5 minutes for first 30 minutes, then every 10 minutes till 60 minutes and subsequently every 15 minutes till the completion of surgery. 2 blood sample will be taken first 1 hour before surgery as base line and second at the end of surgery and send to pathology labe for inflammatory markers assessment.

次要结局

  • . assessment of state-trait anxiety inventory for state anxiety score.(. assessment of patient satisfaction in postoperative period.)

研究者

发起方
Department of Anaesthesiology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mohd Pervez Alam

King Georges Medical University Lucknow

研究点 (1)

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