跳至主要内容
临床试验/NCT02104349
NCT02104349终止不适用

Mindfulness Meditation for Spine Surgery Pain

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2014年2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
38
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

The objective of this study is to evaluate the effect of mindfulness meditation technique on post-operative pain of spine surgery subjects. Subjects will participate in a 6-week mindfulness meditation program, beginning two weeks prior to spine surgery. The investigators are interested in determining if this intervention improves the ability to tolerate pain and reduces anxiety, thus reducing the need for prescribed analgesics and narcotics. The meditation intervention will be compared against a control group consisting of subjects that will undergo music therapy during the same period of time.

详细描述

Mind body therapies which induce relaxation through the use of imagery and meditation, are being increasingly sought as treatments to assist individuals cope with stress and chronic illness. These holistic therapies have become accepted by both physicians and patients because of the recent emerging body of evidence supporting their effectiveness for a variety of physical and psychological conditions. In the case of holistic (or integrative) practices used to alleviate pain, the infrequency of adverse effects makes them particularly attractive to physicians who have become wary of the risks of prescription narcotics.

Pain medications, though they provide immediate relief, have many noted adverse side effects. These include respiratory depression, decreased heart rate and in extreme cases of misuse, death. These medications are especially prone to abuse by patients, even after their initial pain subsides. Overdosing from prescription pain killers has become a significant cause of accidental death, and providers are seeking alternative treatments for pain for their patients that do not carry this risk.

A significant body of research has investigated the benefits of meditation for a wide variety of physical and psychological conditions . However, clinical evidence for the efficacy of meditation for reducing pain is sparse, although some research suggests the mechanisms of this possible benefit , Mindfulness-Based Stress Reduction (MBSR) is a mindfulness intervention which is currently used in over 500 clinical sites around the world for patients with a wide variety of clinical problems, including pain. MBSR was developed by Jon Kabat Zinn at the University of Massachusetts in the 1970s. It is derived from the Oriental traditions of Zen Buddhism, yet free from its religious roots. It is supported by over 30 years of research that substantiate its positive effects on numerous ailments, including stress , chronic pain , anxiety and depression .

The key concept in mindfulness meditation involves learning how to observe the thoughts that enter one's mind without the passing of judgment and by keeping the focus on breathing or another constant. This is called "detached observation". The mechanisms at work are unknown but are thought to be the meditation facilitating the tuning out of distractions by learning to maintain and control attention.

The process of mindfulness meditation entails sitting in a quiet location and comfortable position with one's eyes closed. Individuals are instructed to relax and focus on their breathing, or another chosen object of attention, such as parts of the body in the body scan, body movements in mindful movement, or the act of walking in walking meditation. While the mind may wander and numerous thoughts, worries or concerns may arise, the individual learns to non-self-critically acknowledge the shift in attention, and return to the chosen object of attention. Over time, increased attentional control and awareness of mental events leads to the ability to respond more positively and less reactively to stressful events, including pain.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients that will undergo spine surgery including: single level lumbar fusion, posterior cervical laminectomy fusion, cervical laminaplasty

排除标准

  • Patients with scheduling conflicts that will render them unable to follow the weekly mindfulness mediation instruction.
  • Patients with depression (established during the screening questionnaire)

结局指标

主要结局

Visual Analog Scale

时间窗: 2 weeks prior to surgery

Visual Analog Scale (VAS) to measure pain: a measure of "no pain" to "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Total score ranges 0-10, with higher scores indicating higher levels of pain.

Change in Visual Analog Scale (VAS)

时间窗: Baseline up to 6 weeks

Visual Analog Scale (VAS) to measure pain: a measure of "no pain" to "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line.

次要结局

  • Hospital Anxiety and Depression Scale(baseline up to 6 weeks)
  • Neuropathics dosage(baseline up to 6 weeks)
  • Perceived Stress Scale(baseline up to 6 weeks)
  • Muscle Relaxer Dosage(2 weeks prior to surgery)
  • Antidepressant Dosage(2 weeks prior to surgery)
  • NSAIDS dosage(baseline up to 6 weeks)
  • Oswestry Disability Index(baseline up to 6 weeks)
  • NSAIDS Dosage(2 weeks prior to surgery)
  • Neuropathics Dosage(2 weeks prior to surgery)
  • Narcotics Dosage(2 weeks prior to surgery)
  • Muscle Relaxers dosage(baseline up to 6 weeks)
  • Narcotics dosage(baseline up to 6 weeks)

研究者

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

Arthur L Jenkins

Associate Clinical Professor, Neurosurgery

Icahn School of Medicine at Mount Sinai

研究点 (1)

Loading locations...

相似试验