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临床试验/NCT01874379
NCT01874379Unknown不适用

Investigating the Effect of the 'M'-Technique, Guided Imagery, or Standard of Care on Anxiety and Pain Pre- & Post-operatively in Elective Joint Replacement Patients.

Saint Clare's Health System2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
225
试验地点
2
主要终点
Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain

研究概览

简要总结

In the M-TIJRP protocol the investigators will utilize two Integrative Medicine modalities in a randomized, controlled study using either the 'M'-Technique® developed by Jane Buckle, PhD or Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ with nature sounds to determine their effects on a specific group of pre- and post-operative patients, compared to no integrative medicine intervention - considered Standard of Care. A total of 225 patients undergoing surgical hip or knee replacement will participate; one third of the patient population will receive the 'M'-Technique touch intervention, one third will receive Tusek's Guided Imagery intervention delivered by headsets monitored by therapists from our Center for Complementary Medicine (CCM) and one third will comprise the control group, consisting of routine preoperative & postoperative care without integrated intervention.

Patients will be asked to complete Pain and Anxiety scales at four different timepoints throughout their hospital stay. These will occur at Same Day Surgery (pre-operatively), and Post Operatively Day 0, Day 1 & Day 2.

Rationale: Patients are often at their most vulnerable just prior to surgery when their stress and anticipation are high and again immediately afterward when their energy is lower and their bodies are trying to accommodate after an invasive procedure. In addition, the patient and his or her family sense a lack of control and feel a rise in anxiety over the possible outcomes. This stress, anxiety, and pain associated with surgery and recovery can increase complication rates and slow recovery times resulting in longer hospital stays.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

  • Age > 18 years old
  • Be receiving an initial or subsequent elective hip or knee replacement surgery

排除标准

  • Patients with an active infection or open wound in the location of the extremities where the 'M'-Technique will be performed
  • Patients with touch aversion
  • Non-English speaking patients - due to guided imagery recording availability in English only
  • Patients who demonstrate insufficient auditory discrimination as determined by their ability to engage in normal conversation
  • Patients who lack the sensation of being touched on the hands and/or feet

结局指标

主要结局

Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain

时间窗: 18 months

Measurement with Visual Analogue Scale

Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety

时间窗: 18 months

Visual Analogue Scale

Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2

时间窗: 18 Months

次要结局

  • Patient Satisfaction Measure(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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