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

NCT02861170 | Withdrawn

• 1 other identifier: 20160105-01H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at approximately 48 hours post-surgery.

  The primary outcome will be the mean score of the Brief Pain Inventory (BPI) Interference Scale 48 hours post-surgery. The interference scale measures the degree to which pain interferes in the lives of participants in 7 domains: general activity, mood, walking ability, normal work, relations with other persons, sleep and enjoyment of life on a scale from 0 to 10. The higher the score, the greater the pain interferes with patient's activities.

  Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor

Secondary Outcomes (4)

• Change in pain intensity, as measured by the Brief Pain Inventory.

  Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.

• Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale

  Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.

• Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.

  Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.

• Change in quality of life, as measured by the EuroQOL-5D

  Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.

Study Arms (2)

Brief Mindfulness-Based Intervention

EXPERIMENTAL

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).

Behavioral: Brief Mindfulness-Based Intervention

Education

NO INTERVENTION

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

Interventions

Brief Mindfulness-Based Intervention BEHAVIORAL

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.

Also known as: Body Scan, Guided Meditation

Brief Mindfulness-Based Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

Pain; Chronic Pain

Interventions

Whole Body Imaging

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Patricia Poulin, PhD C. Psych

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: August 10, 2016
• Study Start: February 26, 2018
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)