Clinical trial NCT02861170: Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Hip Pain
Worries; Pain or Disability
Quality of Life
Keywords: Mindfulness
Chronic Pain
Chronic Hip Pain
Total Hip Arthroplasty
Disability
Quality of Life
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at approximately 48 hours post-surgery.
timeFrame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor
Secondary outcomes:
measure: Change in pain intensity, as measured by the Brief Pain Inventory.
timeFrame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
measure: Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale
timeFrame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
measure: Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.
timeFrame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
measure: Change in quality of life, as measured by the EuroQOL-5D
timeFrame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Patricia Poulin, PhD C. Psych
role: PRINCIPAL_INVESTIGATOR
References: