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

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02861170

Collaborator

(none)

Enrollment

Location

Arms

32.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hip Pain Worries; Pain or Disability Quality of Life	Behavioral: Brief Mindfulness-Based Intervention	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

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 :

Feb 26, 2018

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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. Other Names: Body Scan Guided Meditation
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.

Arm

Intervention/Treatment

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.

Other Names:

Body Scan

Guided Meditation

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.]
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 [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. [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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