NCT02861170

Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability

Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability Among Anxious Patients With Chronic Pain Undergoing Total Hip Arthroplasty - a Feasibility and Acceptability Pilot Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty. All participants will receive an educational brochure and links to videos containing strategies for coping with pain and anxiety. The half of the participants who are allocated to the treatment arm will also receive a 10 minute mindfulness intervention called a body scan.

Detailed description

Psychological distress or anxiety is common in patients awaiting surgical procedures and can have impact on both physical and mental health, leading to significantly reduced quality of life. It has been associated with a slower and more complicated postoperative recovery and has been established as an independent predictor of pain and pain related outcomes after surgery. Pharmacological interventions and provision of information about surgical processes are two ways that pre-operative anxiety is currently addressed. Mindfulness-based interventions have shown positive results in reducing psychological distress and improving pain related outcomes and may be a promising treatment avenue to evaluate in a surgical population. With the goal of conducting a full-scale definitive trial to investigate the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty, this pilot study has been developed to demonstrate proof of concept, test/refine the intervention, recruitment, and data collection procedures, and test the intervention's acceptability in the peri-operative setting.

Conditions

• Chronic Hip Pain
• Worries; Pain or Disability
• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	Brief Mindfulness-Based Intervention	In addition to the educational materials that will be provided to all participants, the participants in the intervention group will also receive a 10-minute mindfulness-based intervention called a body scan. The body scan is a guided meditation exercise where participants are lead through focusing their attention on their body while maintaining awareness and acceptance of their sensations, emotions, and thoughts without trying to control or change them. The goal of the intervention is to increase mindfulness (i.e., moment-to-moment, non-judgmental and non-reactive awareness of sensations, emotions and thoughts), to provide self-regulation strategies, and to promote healthy and adaptive responses to stress.

Timeline

• Start date: 2018-02-26
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2016-08-10
• Last updated: 2020-11-30

Locations

1 site across 1 country: Canada