跳至主要内容
临床试验/NCT04932499
NCT04932499Unknown不适用

Can Mindfulness Meditation Reduce Peri-Operative Pain and Anxiety Following Total Joint Arthroplasty?

University of Calgary2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
32
试验地点
2
主要终点
Change in Numerical Rating Scale (NRS) pain scores

研究概览

简要总结

Health care professionals are dedicated to the ongoing evaluation of the peri-operative experience, and always striving to improve patient satisfaction. There are extensive protocols and communication strategies to optimize pre-operative education, intra-operative comfort and safety, and post-operative pain control, but most strategies are carried out by the treating team. The idea of using mindfulness to empower patients to be active participants in reducing pain and anxiety has already been successful in a number of medical settings.

Multiple studies have demonstrated the effectiveness of mindfulness based stress reduction and mindfulness based cognitive therapy, a modification to treat depression. Mindfulness has been shown to reduce catastrophizing, depression and disability, all of which are of concern with respect to long-term success after arthroplasty. There is limited evidence to demonstrate the usefulness of mindfulness as a peri-operative intervention. Although there is evidence that a brief mindfulness meditation session can impact experimental pain scores and anxiety, there is no current literature that has evaluated the impact of such a session as part of the peri-operative teaching protocol with respect to pain and anxiety.

Our objective is to assess the capability of a short-term mindfulness intervention (serving as a compliment to the pre-operative pathway for total joint arthroplasty) to reduce peri-operative pain that can be integrated with the existing arthroplasty pathway. In addition, we explore the utility of using such a tool to reframe patients' expectation of the peri-operative period as evidence by its impact on anxiety and post-operative patient satisfaction.

Thirty-two participants will be recruited and randomly assigned to either control or treatment groups. The control group will receive standard care associated with total joint arthroplasty. The treatment group will receive a 45-60 minute mindfulness meditation teaching session administered by a credentialed mindfulness instructor and affiliated with the University of Calgary Psychosocial Oncology Mindfulness Program in addition to standard care for arthroplasty surgery. The treatment group will be assigned "homework" recordings of body scan exercises and asked to listen to the recording daily for the two-week period prior to surgery. Patients will be asked to listen to their body scan meditation immediately prior to entering the operating room and daily each post-operative day while in hospital. Longitudinal assessments encompassing the preoperative, peri-operative and post-operative periods will be acquired using validated pain scores and anxiety outcomes scores including the Numerical Rating Scale (NRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the short-form State-Trait Anxiety Inventory.

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
Double (Investigator, Outcomes Assessor)

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

  • elective total knee arthroplasty

排除标准

  • non-English speaking
  • patients requiring general anesthesia
  • psychiatric illness
  • chronic pain requiring > 8 tablets per day of tramacet, Tylenol #3 or Percocet
  • joint revision surgery
  • patients who meet criteria for acute pain service stratification and referral

结局指标

主要结局

Change in Numerical Rating Scale (NRS) pain scores

时间窗: day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative

Longitudinal assessment of Numerical Rating Scale (NRS) pain scores. Scale ranges from 0-10 with 0 representative of no pain to 10 worst pain possible

次要结局

  • Change in Anxiety Scores(day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative)
  • Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative)

研究者

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

Farrah Morrow

Clinical Assistant Professor

University of Calgary

研究点 (2)

Loading locations...

相似试验