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

Ottawa Hospital Research Institute

Status: Withdrawn

Conditions: Quality of Life; Chronic Hip Pain; Worries; Pain or Disability

Treatments: Behavioral: Brief Mindfulness-Based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02861170

20160105-01H

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (age 18+) patients presenting at the Pre-Admission Unit (PAU) at the General campus of The Ottawa Hospital (TOH) for total hip arthroplasty (THA)
• History of pain for ≥3 months (chronic pain)
• Anxiety scores of ≥8 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
• Ability to understand oral and written English or French

Exclusion criteria

• Refusal or inability to provide consent
• Severe depressive symptoms as indicated by score ≥ 20 on the Patient Health Questionnaire (PHQ-9) scale
• Prior mindfulness training experience
• Pre-planned same day discharge after surgery

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Brief Mindfulness-Based Intervention

Experimental group

Description:

Participants in this arm will be provided with an educational brochure and links to videos containing strategies for coping with pain and anxiety as well as a 10-minute mindfulness-based intervention called a body scan at 3 different time-points (T1 - 1 week prior to surgery, T2 - within 4 hours before surgery, and T3 - approximately 24 hours after transfer from recovery to the orthopedic floor).

Treatment:

Behavioral: Brief Mindfulness-Based Intervention

Education

No Intervention group

Description:

Participants in this arm will be provided with an educational brochure and links to videos containing strategies for coping with pain and anxiety.