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临床试验/NCT04855968
NCT04855968终止不适用

The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
55
试验地点
2
主要终点
visual analog scale

研究概览

简要总结

The objective of this study is to examine the effectiveness of mindfulness/meditation using the Headspace App on post-operative pain and opioid consumption in patients after arthroscopic rotator cuff repairs, biceps tenodesis, and Mumford procedures.

详细描述

The purpose of this study is to examine the effectiveness of mindfulness/meditation on post-operative pain and opioid consumption. Patients will be randomized into one of two standardized groups after shoulder arthroscopy: Control group (CON) and mindfulness/meditation group (MM). All participants will be consented and enrolled into the study before surgery. Both groups will receive the same standardized method of post-operative pain medication for post-operative pain relief. Participants in the MM group will utilize a Headspace application on their smart phone meditate twice a day while the control group will not perform any meditation or mindfulness. Patient reported outcomes will be collected at regular intervals. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff repair and/or biceps tenodesis and/or Mumford procedure. The study includes 3 visits which are standard of care pre-operative and post-operative visits. The duration of the study will be 6 months which will include 3 standard of care post-operative visits and electronic surveys to track patient reported outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years and older
  • Status post shoulder arthroscopy for rotator cuff repair, biceps tendinopathy, and/or Mumford Procedure

排除标准

  • Less than 18 years old
  • Patients undergoing a simultaneous arthroscopic procedure that is not in the inclusion criteria.
  • History of shoulder osteoarthritis

结局指标

主要结局

visual analog scale

时间窗: 6 months post-op

single-item measure of pain and consists of a 100 millimeter (mm) horizontal line with the labels "No Pain" at the leftmost portion and "Worst Pain" at the rightmost portion of the line

number of opioid pills

时间窗: 6months post-op

number of pills taken at each time point

次要结局

  • Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)(6 months post-op.)
  • compliance of the intervention in the MM groups which will be tracked via the Headspace application.(6 months post-op)
  • Patient reported out comes :Single Assessment Numeric Evaluation (SANE)(6 moths post-op.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Banffy, MD

Principal investigator

Cedars-Sinai Medical Center

研究点 (2)

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