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.
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
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.
- Conditions
- Knee Osteoarthritis
- 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 group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard of care Receives: Other: Standard of Care |
| Mindfulness Meditation | Experimental | Mindfulness 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.
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)
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
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.
- First posted21 Jun 2021
- Study startAug 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farrah Morrow, University of Calgary
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Mindfulness Meditation Reduce Peri-Operative Pain and Anxiety Following Total Joint Arthroplasty?
- ClinicalTrials.gov ID
- NCT04932499
- Acronym / sponsor ID
- Mindfulness Study
- Conditions
- Knee Osteoarthritis
- Keywords
- Total Hip Arthroplasty, Mindfulness Meditation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single blinded, block randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard of CareStandard of care |
| Mindfulness Meditation | Experimental | Other: Standard of Care, Other: Mindfulness MeditationMindfulness meditation in addition to standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective total knee arthroplasty
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareParticipants 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. | Other | Control group, Mindfulness Meditation |
| Mindfulness MeditationIn 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. | Other | Mindfulness Meditation |
Primary outcome
Change in Numerical Rating Scale (NRS) pain scores
Time frame: day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative
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
2 secondary outcomes
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative
Change in Anxiety Scores
Time frame: day of surgery; daily as inpatient; 7 days postoperative; 14 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.