Mindfulness Meditation for Surgical Pain and Anxiety

Knee Osteoarthritis Clinical Trial

Official title:

Can Mindfulness Meditation Reduce Peri-Operative Pain and Anxiety Following Total Joint Arthroplasty?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04932499
• Other study ID #: Mindfulness Study
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: January 2022

Study information

• Verified date: June 2021
• Source: University of Calgary
• Contact: Farrah Morrow, MD, FRCPC
• Phone: 403-956-3883
• Email: farrah.morrow[@]albertahealthservice.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Standard of Care
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.
• Mindfulness Meditation
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.

Locations

Country	Name	City	State
Canada	South Health Campus	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative
Secondary	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	day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative
Secondary	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)	day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative