Clinical trial NCT04932499: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total Hip Arthroplasty
Mindfulness Meditation
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded, block randomized controlled trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Numerical Rating Scale (NRS) pain scores
timeFrame: day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative
Secondary outcomes:
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative
measure: Change in Anxiety Scores
timeFrame: day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
Study officials:
References: