Mindfulness Meditation for Surgical Pain and Anxiety

NCT04932499 | Unknown

• 1 other identifier: Mindfulness Study
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Total Hip Arthroplasty; Mindfulness Meditation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative

• Change in Anxiety Scores

  day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative

Study Arms (2)

Control group

ACTIVE COMPARATOR

Standard of care

Other: Standard of Care

Mindfulness Meditation

EXPERIMENTAL

Mindfulness meditation in addition to standard of care

Other: Standard of Care; Other: Mindfulness Meditation

Interventions

Standard of Care OTHER

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.

Control group; Mindfulness Meditation

Mindfulness Meditation OTHER

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.

Mindfulness Meditation

Eligibility Criteria

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

You may qualify if:

• elective total knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Standard of Care; Mindfulness

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Farrah Morrow, MD, FRCPC

CONTACT

403-956-3883; farrah.morrow@albertahealthservice.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Single blinded, block randomized controlled trial

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 21, 2021
• Study Start: August 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

CA (1)