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临床试验/NCT04788329
NCT04788329已完成不适用

The Effect of Mindfulness Programs on Postoperative Pain

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Change of Measured Pain

研究概览

简要总结

Participants undergoing hand surgery will be assessed and compared for postoperative pain. The patients' experience of going through surgery will be evaluated. The patient satisfaction and patient assessed outcomes will be measured.

详细描述

Participants undergoing hand surgery will be randomized into either a control group or one of two groups that undergo mindfulness training during the perioperative period. One of the treatment groups will be enrolled in the program "Prepare for Surgery, Heal Faster" provided by NYU. The other treatment group will be enrolled in Wim Hof Method, a meditation program. This program is not provided by NYU, but instructions will be provided to the patient on how to complete the meditative exercises involved in this established method. Postop pain medication and pain scores will be monitored.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patient seen in Dr. Paksima's office
  • •Scheduled for hand surgery
  • •Able to provide consent

排除标准

  • •Less than 18 years old
  • •Inability to consent
  • •Not fluent in English

研究组 & 干预措施

Relaxation Group

Experimental

This program teaches patients how to feel calmer before surgery. Patients are taught relaxation techniques by phone or in person by trained NYU personnel.

干预措施: "Prepare for Surgery, Heal Faster" Program (Behavioral)

Meditation Group

Experimental

This treatment group will be enrolled in Wim Hof Method, a meditation program. Patients in this group will take the online "The Fundamentals Course" provided by the Wim Hof Method. The patients will be introduced to the online course preoperatively

干预措施: Wim Hof Method (Behavioral)

Standard Care Group

No Intervention

The control group will get the standard of care therapy after surgery.

结局指标

主要结局

Change of Measured Pain

时间窗: Day 0, 2 weeks, 6 weeks, 3 months, 1 year

Pain will be measured by the visual analog scale (VAS) scale, The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

次要结局

  • Change in Mindfulness Score of MAAS scale(Day 0, 2 weeks, 6 weeks, 3 months, 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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