Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability (CALM)
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|ClinicalTrials.gov Identifier: NCT02861170|
Recruitment Status : Suspended (Study was a pilot and after recruitment started it was determined to not be feasible. Therefore study protocol will be reviewed to adjust for changes.)
First Posted : August 10, 2016
Last Update Posted : July 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hip Pain Worries; Pain or Disability Quality of Life||Behavioral: Brief Mindfulness-Based Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||February 26, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Brief Mindfulness-Based Intervention
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
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.
No Intervention: Education
Participants in this arm will be provided with an educational brochure and links to videos containing strategies for coping with pain and anxiety.
- Change in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at approximately 48 hours post-surgery. [ Time Frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor ]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.
- Change in pain intensity, as measured by the Brief Pain Inventory. [ Time Frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor. ]The Brief Pain Inventory (BPI) Pain Severity Scale measures the severity of pain one feels at worst, at least, on average, and at the time of questionnaire completion on a scale from 0 to 10. The higher the score, the greater the pain severity.
- Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale [ Time Frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor. ]The Pain Catastrophizing Scale (PCS) is a 13-item instrument which will evaluate the degree to which patients have negative self-statements and catastrophizing thoughts and ideations when in pain. The PCS uses a 5-point likert scale (0=not at all, 4=all the time) and consists of three subscales (rumination, magnification, helplessness).
- Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire. [ Time Frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor. ]Mindfulness will be measured using the Short Form Five Facet Mindfulness Questionnaire (FFMQ-SF). The FFMQ-SF is a 24-item instrument measuring five aspects of mindfulness: Non-reactivity to inner experience, observing, describing, acting with awareness, and non-judging of experience. Participants are asked to use a 5-point Likert-type scale (1 = never or rarely true; 5 = very often or always true) to rate how true of them they believe each statement to be.
- Change in quality of life, as measured by the EuroQOL-5D [ Time Frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor. ]The EuroQOL-5D (EQ-5D) is a simple-to-use, valid, and sensitive instrument measuring quality of life. It covers 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, or severe problems and participants use a tick box to select the statement that is most representative of their conditions. Participants are also asked to rate, using a visual analogue scale (0 to 100), their state of health.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861170
|Ottawa Hospital Research Institute|
|Ottawa, Ontario, Canada, K1H8L6|
|Principal Investigator:||Patricia Poulin, PhD C. Psych||Ottawa Hospital Research Institute|