跳至主要内容
临床试验/CTRI/2023/10/059065
CTRI/2023/10/059065尚未招募3 期

Effect of a Holistic Mind Body intervention in patients with Coronary Artery Bypass Graft surgery: a single blind Randomized Clinical Trial.

Dr Shweta Manwadkar1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年2月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
78
试验地点
1
主要终点
6 Minute walk test ( 6 MWT)

研究概览

简要总结

Mind-body therapies such as mindfulness meditation (MM) are increasingly being studied and they seem to be offering multitudes of benefits.  Since becoming popular in the 1970s, MM has been shown to improve psychological states such as anxiety and depression. The scope of MM has expanded in recent years, and MM has been shown to have positive effects on pain, recovery time, and even wound healing after surgery. Training patients in MM before surgery may be implemented at low cost and up to 24 hours before admission. Given these benefits, complementary mind-body therapies such as MM have potential to improve a patient’s surgical experience and outcomes.

Chest physiotherapy in the form of breathing exercises, secretion removal techniques etc and early bedside and out of bed ambulation are proven to be effective and are a part of the post op management protocol of standard physiotherapy or  usual care routinely practiced everywhere.

There have been studies done on effect of mindfulness meditation in Myocardial infarction patients, in patients with chronic pain , in patients with anxiety/depressionand even in normal healthy individuals. There are a few studies done to check effect of MM on joint surgeries, oncology patients and gynecological surgeries. Few studies are found seeing effect of MM on acute post op pain. However there is paucity of literature in checking effect of MM in post elective CABG patients functional recovery.

This study therefore aims to fill this gap by checking the effect of a holistic mind body intervention with standard  physiotherapy in CABG patients in view of assessing the effect of a holistic intervention.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Both males and females 2.Undergoing Elective CABG 3.Age group 40-70 years 4.Medically fit to undergo PT 5.Post-surgery day 1 sternotomy pain >3 on NPRS on movement.

排除标准

  • 1.H/o previous CABG 2.Patients with diagnosed musculoskeletal, neurological , psychiatric conditions , Autoimmune disorders, Malignancy 3.Patients with post op Cardiac, Neurological complications 4.Mini mental scale examination score < 24 Patients having any uncorrected visual, auditory and cognitive problems 5.Patients practicing any form of mediation regularly.

结局指标

主要结局

6 Minute walk test ( 6 MWT)

时间窗: 1st baseline reading is obtained, outcome measures 6 Min walk test be assessed for 2nd time at discharge & for 3rd time 4 weeks Post Surgery

次要结局

  • Numeric Pain Rating Scale (NPRS)(1st baseline reading is obtained, outcome measures for 2nd time Post Operation Day 1 , 3rd time at discharge & for 4th time 4 weeks Post Surgery)
  • Hospital Anxiety Depression Scale (HADS)(1st baseline reading is obtained, outcome measures HADS test be assessed for 2nd time at discharge & for 3rd time 4 weeks Post Surgery)
  • Quality of Recovery Scale (QOR 40)(1st baseline reading is obtained, outcome measures QOR 40 test be assessed for 2nd time at discharge & for 3rd time 4 weeks Post Surgery)

研究者

发起方
Dr Shweta Manwadkar
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验