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Mindfulness Meditation for Surgical Pain and Anxiety

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard of Care
Mindfulness Meditation
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total Hip Arthroplasty, Mindfulness Meditation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elective total knee arthroplasty

Exclusion Criteria:

  • non-English speaking
  • patients requiring general anesthesia
  • psychiatric illness
  • chronic pain requiring > 8 tablets per day of tramacet, Tylenol #3 or Percocet
  • joint revision surgery
  • patients who meet criteria for acute pain service stratification and referral

Sites / Locations

  • South Health Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Mindfulness Meditation

Arm Description

Standard of care

Mindfulness meditation in addition to standard of care

Outcomes

Primary Outcome Measures

Change in Numerical Rating Scale (NRS) pain scores
Longitudinal assessment of Numerical Rating Scale (NRS) pain scores. Scale ranges from 0-10 with 0 representative of no pain to 10 worst pain possible

Secondary Outcome Measures

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Longitudinal assessment of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Individual test questions are scored on a scale from 0-4 with 0 representing "none" to 4 representing "extreme". Total score is 96 with a higher score representing more pain, increased stiff, decreased physical function
Change in Anxiety Scores
Longitudinal assessment of short-form State-Trait Anxiety Inventory (STAI). This assessment consists of six questions with scores ranging from 6 to 24 (high score representative of increased anxiety)

Full Information

First Posted
June 4, 2021
Last Updated
June 21, 2021
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT04932499
Brief Title
Mindfulness Meditation for Surgical Pain and Anxiety
Official Title
Can Mindfulness Meditation Reduce Peri-Operative Pain and Anxiety Following Total Joint Arthroplasty?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Health care professionals are dedicated to the ongoing evaluation of the peri-operative experience, and always striving to improve patient satisfaction. There are extensive protocols and communication strategies to optimize pre-operative education, intra-operative comfort and safety, and post-operative pain control, but most strategies are carried out by the treating team. The idea of using mindfulness to empower patients to be active participants in reducing pain and anxiety has already been successful in a number of medical settings. Multiple studies have demonstrated the effectiveness of mindfulness based stress reduction and mindfulness based cognitive therapy, a modification to treat depression. Mindfulness has been shown to reduce catastrophizing, depression and disability, all of which are of concern with respect to long-term success after arthroplasty. There is limited evidence to demonstrate the usefulness of mindfulness as a peri-operative intervention. Although there is evidence that a brief mindfulness meditation session can impact experimental pain scores and anxiety, there is no current literature that has evaluated the impact of such a session as part of the peri-operative teaching protocol with respect to pain and anxiety. Our objective is to assess the capability of a short-term mindfulness intervention (serving as a compliment to the pre-operative pathway for total joint arthroplasty) to reduce peri-operative pain that can be integrated with the existing arthroplasty pathway. In addition, we explore the utility of using such a tool to reframe patients' expectation of the peri-operative period as evidence by its impact on anxiety and post-operative patient satisfaction. Thirty-two participants will be recruited and randomly assigned to either control or treatment groups. The control group will receive standard care associated with total joint arthroplasty. The treatment group will receive a 45-60 minute mindfulness meditation teaching session administered by a credentialed mindfulness instructor and affiliated with the University of Calgary Psychosocial Oncology Mindfulness Program in addition to standard care for arthroplasty surgery. The treatment group will be assigned "homework" recordings of body scan exercises and asked to listen to the recording daily for the two-week period prior to surgery. Patients will be asked to listen to their body scan meditation immediately prior to entering the operating room and daily each post-operative day while in hospital. Longitudinal assessments encompassing the preoperative, peri-operative and post-operative periods will be acquired using validated pain scores and anxiety outcomes scores including the Numerical Rating Scale (NRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the short-form State-Trait Anxiety Inventory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total Hip Arthroplasty, Mindfulness Meditation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blinded, block randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard of care
Arm Title
Mindfulness Meditation
Arm Type
Experimental
Arm Description
Mindfulness meditation in addition to standard of care
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Participants randomly assigned to this intervention will receive standard of care given to all patients undergoing total knee arthroplasty at our institution as outlined in the Common Care Pathway for Total Joint Replacement. Outcome assessments will be completed pre-operatively, each day while in hospital and 7 and 14 days postoperative.
Intervention Type
Other
Intervention Name(s)
Mindfulness Meditation
Intervention Description
In addition to standard of care, participants randomly assigned to the treatment group will be given a 45-60 minute teaching session on mindfulness meditation. Upon completion of this session, participants will be given "homework" recordings of a body scan exercise and asked to listen to the recording daily for the two-week period prior to surgery. Participants will be asked to listen to their recording immediately prior to their surgery and daily while in hospital. In addition, participants assigned to mindfulness intervention will receive standard of care as outlined in the control group. Outcome assessments will be completed pre-operatively, each day while in hospital and 7 and 14 days postoperative.
Primary Outcome Measure Information:
Title
Change in Numerical Rating Scale (NRS) pain scores
Description
Longitudinal assessment of Numerical Rating Scale (NRS) pain scores. Scale ranges from 0-10 with 0 representative of no pain to 10 worst pain possible
Time Frame
day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative
Secondary Outcome Measure Information:
Title
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
Longitudinal assessment of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Individual test questions are scored on a scale from 0-4 with 0 representing "none" to 4 representing "extreme". Total score is 96 with a higher score representing more pain, increased stiff, decreased physical function
Time Frame
day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative
Title
Change in Anxiety Scores
Description
Longitudinal assessment of short-form State-Trait Anxiety Inventory (STAI). This assessment consists of six questions with scores ranging from 6 to 24 (high score representative of increased anxiety)
Time Frame
day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elective total knee arthroplasty Exclusion Criteria: non-English speaking patients requiring general anesthesia psychiatric illness chronic pain requiring > 8 tablets per day of tramacet, Tylenol #3 or Percocet joint revision surgery patients who meet criteria for acute pain service stratification and referral
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farrah Morrow, MD, FRCPC
Phone
403-956-3883
Email
farrah.morrow@albertahealthservice.ca
Facility Information:
Facility Name
South Health Campus
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farrah Morrow, MD, FRCPC
Phone
403-956-3883
Email
Farrah.morrow@albertahealthservices.ca

12. IPD Sharing Statement

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Mindfulness Meditation for Surgical Pain and Anxiety

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