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Knee OsteoarthritisNCT04932499

Mindfulness Meditation for Surgical Pain and Anxiety

A study testing Mindfulness Meditation in people with Knee Osteoarthritis, run by University of Calgary at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Mindfulness Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteCanada
Study dates
Aug 2021to Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • elective total knee arthroplasty

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • South Health Campus

    Calgary, Alberta, T3M 1M4

    Farrah Morrow, MD, FRCPC, 403-956-3883, Farrah.morrow@albertahealthservices.ca

Other trials in Canada

About this study

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

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.

Read more

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.

Being tested
Standard of Care, Mindfulness Meditation
Keywords
Total Hip Arthroplasty, Mindfulness Meditation
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of CareOther

    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 MeditationOther

    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.

Study groups in NCT04932499
Study groupRoleWhat they receive
Control groupActive comparatorStandard of care
Receives: Other: Standard of Care
Mindfulness MeditationExperimentalMindfulness meditation in addition to standard of care
Receives: Other: Standard of Care; Other: Mindfulness Meditation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (2)
  1. 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

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

  2. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2021
  2. Study startAug 2021 (estimated)
  3. Primary completionJan 2022 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single blinded, block randomized controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04932499
Sponsor's protocol ID
Mindfulness Study
Status last verified
Jun 2021
First submitted
4 Jun 2021
Last updated
23 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Meditation in people with Knee Osteoarthritis, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Farrah Morrow, MD, FRCPC (403-956-3883, farrah.morrow@albertahealthservice.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Numerical Rating Scale (NRS) pain scores (time frame: day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.

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