Total Knee ReplacementNCT06180486
Mindfulness Meditation Intervention Study
A study testing Mindfulness Meditation Intervention in people with Total Knee Replacement and Mediation, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement, Mediation, Feasibility
- What is being tested?
- Mindfulness Meditation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 11 Feb 2025
- 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
- Adult patients undergoing primary total knee arthroplasty with a participating surgeon
- Patients on these medications for anxiety/depression: Fluoxetine, Paroxetine, Citalopram, Escitalopram, Sertraline, Fluvoxamine, Venlafaxine, Duloxetine, Levomilnacipran, Desvenlafaxine, Bupropion, Mirtazapine, Amitriptyline, Nortriptyline, Clonazepam, Alprazolam, Lorazepam, Diazepam, Oxazepam, Chlordiazepoxide
- Patients receiving intraoperative auricular acupuncture as part of participating surgeon's preferred anesthetic care
- Patients fluent in English
- ASA I-III
- BMI < 40
Who cannot join
- Patient not fluent in English (inability to understand the intervention video will likely affect ability to utilize the mindfulness techniques taught)
- Pediatric patients < 18 years of age
- Patients with contraindications to intra-op protocol
- Patients with contraindications to auricular acupuncture (non-native ear, active ear infection, gauges in the ears)
- Patients unable/unwilling to participate in the questionnaires or view the scripted intervention
- Patients scheduled for consecutive or staged surgeries
- Patients allergic to local anesthetics or study medications
- Patients who have kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Preoperative Mindfulness Meditation for Total Knee Arthroplasty: A Pilot Study
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention can train resilience. The main questions it aims to answer are:
- Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery?
- Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study?
- Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls? Can preoperative a mindfulness meditation intervention train resilience (as measured by increased resilience score)?
Read more
Participants will be randomly assigned to be in the intervention group or the waitlist control group. The intervention group gets the mindfulness mediation intervention prior to their day of surgery, and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery.
The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days.
Read the detailed description
This study will investigate the effect of a preoperative mindfulness meditation intervention (MMI) on outcomes for total knee arthroplasty (TKA) patients at the Hospital for Special Surgery in a randomized controlled trial. Mindfulness meditation is a practice well-known to psychology research based on sustained attention on the present and a non-judgment of one's current situation. It has been used for numerous psychological issues including stress, anxiety, and depression. This intervention group will be compared against a waitlist control group (patients will be told they are on a waitlist to receive the mindfulness intervention, which will occur after data collection has finished for their group). This control has been utilized in several mindfulness meditation studies.
Measures of anxiety, depression, resilience, pain and pain unpleasantness, and overall physical and mental health will be taken after randomization, but before the intervention (or being told they are on the waitlist). Overall physical and mental health measures will also be taken on the day of surgery and final surveys will be collected at 90 days post-op.
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention can train resilience. The main questions it aims to answer are:
- Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery?
- Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study?
- Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls? Can preoperative a mindfulness meditation intervention train resilience (as measured by increased resilience score)?
Participants will be randomly assigned to be in the intervention group or the waitlist control group. The intervention group gets the mindfulness mediation intervention prior to their day of surgery, and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery.
The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days.
- Conditions
- Total Knee Replacement, Mediation, Feasibility
- Being tested
- Mindfulness Meditation Intervention
- Medical subject headings
- Negotiating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation InterventionOther
The mindfulness intervention is a scripted, ~12min audio recording based on core tenets of mindfulness meditation and contextualized for patients undergoing total knee arthroplasty. It teaches sustained attention on the present, body awareness, acceptance of the body's current state, and transformational strategies to cope with emotional or physical stimuli as they arise. It has been created by the study team based on the teachings of Jon Kabat Zinn (founder of mindfulness meditation) and the PI's history teaching yoga and meditation. Patients will be encouraged to review the audio recording once a week.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control: Receive MMI After 90 days | Other | The waitlist control group will allow for comparison of those who had access to the mindfulness meditation intervention (MMI) prior to surgery to those who did not. This group will be given the mindfulness meditation intervention 90 days after their surgery when all study questionnaires are complete. Up until 90-days, they will be asked the same questionnaires as the intervention group aside from the MMI practice survey and the exit survey. They will then be given the exit survey 2 weeks after receiving the MMI. This is done to ensure that both groups receive the potential benefit of the teachings and to deter patient dropout for those interested in the study because of wanting to receive the mindfulness training. Receives: Other: Mindfulness Meditation Intervention |
| Intervention: Receive MMI before their day of surgery | Experimental | The intervention group will be given the mindfulness meditation intervention (MMI) 1 week prior to their day of surgery. Up until 90-days, they will be asked the same questionnaires as the waitlist control group, with the addition of the MMI practice survey and the exit survey. Receives: Other: Mindfulness Meditation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mental health score
PROMIS Mental Health Questionnaire is to assess general mental health in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questionsare excellent, very good, good, fair, or poor.
Measured: 1 week prior to surgery to post operative day 90
Anxiety
Generalized Anxiety Disorder Assessment (GAD-7) is used to assess severe anxiety in patients 1 Week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are not at all sure, several days, over half the days, or nearly every day.
Measured: 1 week prior to surgery to post operative day 90
Depression
The Patient Health Questionnaire (PHQ-9) is to assess depression in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are not at all, Several days, more than half the days, and nearly every day.
Measured: 1 week prior to surgery to post operative day 90
Overall physical health scores
PROMIS Physical Health Questionnaire is used to assess general physical health in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are excellent, very good, good, fair, or poor.
Measured: 1 week prior to surgery to post operative day 90
Knee health
The KOOS-JR questionnaire will assess knee health after a total knee replacement surgery 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are none, mild, moderate, severe, or extreme.
Measured: 1 week prior to surgery to pre operative holding
MMI Practice Survey
The mindfulness meditation intervention practice survey helps to assess enrollment, retention, intervention completion and use measured by time to full enrollment, dropout number/proportion, number of MMI views/uses. The MMI practice survey is asked to the intervention group in pre-operative holding, post-operative day 14 and post-operative day 90. There are several different responses to these questions. These responses include yes or no; from 1-5+; emotional destress or physical pain; Not at all, somewhat improved, improved, or greatly improved.
Measured: pre-operative holding to post-operative day 90
Exit Survey
The exit survey is used to assess ease and helpfulness of the mindfulness meditation intervention to the patients. This is asked to the intervention group in pre-operative holding, post-operative day 14 and post-operative day 90. This survey includes several different respnses to its questions. Responses include; open ended responses; yes or no; < 1 week, 1-2 weeks, 3-4 weeks, or 4+ weeks.
Measured: pre-operative holding to post-operative day 90
Secondary outcomes (5)
Pain outcomes of patients
The Pain Unpleasantness scale uses verbal descriptors to asses pain at 1 week prior to surgery, day of surgery, post-acute care unit (PACU), post operative day 14, and post operative day 90. The response to this questionnaire are slightly unpleasant, slightly annoying, unpleasant, annoying, slightly, distressing, very unpleasant, distressing, very annoying, slightly intolerable, very distressing, intolerable, or very intolerable.
Measured: 1 week prior to surgery to post operative day 90
Numerical Rating Scale (NRS)
The NRS assesses pain levels on a scale from 0-10 in the operative knee 1 week prior to surgery, day of surgery, post-acute care unit (PACU), post operative day 14, and post operative day 90.
Measured: 1 week prior to surgery to post operative day 90
Resilience training
The Brief Resilience Scale is used to assess the ability to recover from stress 1 Week prior to surgery, post operative day 14, and post operative day 90. The responses to this questionnaire are strongly agree, disagree, neutral, agree, strongly agree.
Measured: 1 week prior to surgery to post operative day 90
Patient satisfaction
The patient satisfaction survey will assess patient satisfaction with results of the total knee replacement surgery taken on post operative day 14. The responses to this questionnaire range from 0-10, 0 being strongly dissatisfied and 10 being strongly satisfied.
Measured: Post operative day 14
Pain catastrophizing scale
The pain catastrophizing scale assess pain experience and ability to cope with pain 1 week prior to surgery. The responses to this questionnaire are not at all, to a slight degree, to a moderate degree, to a great degree, or all the time.
Measured: 1 week prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start2 Feb 2024
- Primary completion28 Jan 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial of two groups, intervention vs waitlist control
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Li, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180486
- Sponsor's protocol ID
- 2023-2131
- Status last verified
- Oct 2024
- First submitted
- 12 Dec 2023
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng SI, Kelleher DC, DeMeo D, Zhong H, Birch G, Ast MP. Intraoperative Acupuncture as Part of a Multimodal Analgesic Regimen to Reduce Opioid Usage After Total Knee Arthroplasty: A Prospective Cohort Trial. Med Acupunct. 2022 Feb 1;34(1):49-57. doi: 10.1089/acu.2021.0072. Epub 2022 Feb 14.
PubMed 35251437Denkova E, Zanesco AP, Rogers SL, Jha AP. Is resilience trainable? An initial study comparing mindfulness and relaxation training in firefighters. Psychiatry Res. 2020 Mar;285:112794. doi: 10.1016/j.psychres.2020.112794. Epub 2020 Jan 16.
PubMed 32078885Hanley AW, Gililland J, Erickson J, Pelt C, Peters C, Rojas J, Garland EL. Brief preoperative mind-body therapies for total joint arthroplasty patients: a randomized controlled trial. Pain. 2021 Jun 1;162(6):1749-1757. doi: 10.1097/j.pain.0000000000002195.
PubMed 33449510Hirschmann MT, Testa E, Amsler F, Friederich NF. The unhappy total knee arthroplasty (TKA) patient: higher WOMAC and lower KSS in depressed patients prior and after TKA. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2405-11. doi: 10.1007/s00167-013-2409-z. Epub 2013 Jan 29.
PubMed 23358576Hofmann SG, Gomez AF. Mindfulness-Based Interventions for Anxiety and Depression. Psychiatr Clin North Am. 2017 Dec;40(4):739-749. doi: 10.1016/j.psc.2017.08.008. Epub 2017 Sep 18.
PubMed 29080597Jones AR, Al-Naseer S, Bodger O, James ETR, Davies AP. Does pre-operative anxiety and/or depression affect patient outcome after primary knee replacement arthroplasty? Knee. 2018 Dec;25(6):1238-1246. doi: 10.1016/j.knee.2018.07.011. Epub 2018 Aug 16.
PubMed 30121151Judge A, Arden NK, Cooper C, Kassim Javaid M, Carr AJ, Field RE, Dieppe PA. Predictors of outcomes of total knee replacement surgery. Rheumatology (Oxford). 2012 Oct;51(10):1804-13. doi: 10.1093/rheumatology/kes075. Epub 2012 Apr 24.
PubMed 22532699Kwak S, Lee TY, Jung WH, Hur JW, Bae D, Hwang WJ, Cho KIK, Lim KO, Kim SY, Park HY, Kwon JS. The Immediate and Sustained Positive Effects of Meditation on Resilience Are Mediated by Changes in the Resting Brain. Front Hum Neurosci. 2019 Mar 26;13:101. doi: 10.3389/fnhum.2019.00101. eCollection 2019.
PubMed 30983980Magaldi RJ, Staff I, Stovall AE, Stohler SA, Lewis CG. Impact of Resilience on Outcomes of Total Knee Arthroplasty. J Arthroplasty. 2019 Nov;34(11):2620-2623.e1. doi: 10.1016/j.arth.2019.06.008. Epub 2019 Jun 12.
PubMed 31278038Sharma AK, Elbuluk AM, Gkiatas I, Kim JM, Sculco PK, Vigdorchik JM. Mental Health in Patients Undergoing Orthopaedic Surgery: Diagnosis, Management, and Outcomes. JBJS Rev. 2021 Jul 23;9(7). doi: 10.2106/JBJS.RVW.20.00169.
PubMed 34297704Singh JA, Yu S, Chen L, Cleveland JD. Rates of Total Joint Replacement in the United States: Future Projections to 2020-2040 Using the National Inpatient Sample. J Rheumatol. 2019 Sep;46(9):1134-1140. doi: 10.3899/jrheum.170990. Epub 2019 Apr 15.
PubMed 30988126Vissers MM, Bussmann JB, Verhaar JA, Busschbach JJ, Bierma-Zeinstra SM, Reijman M. Psychological factors affecting the outcome of total hip and knee arthroplasty: a systematic review. Semin Arthritis Rheum. 2012 Feb;41(4):576-88. doi: 10.1016/j.semarthrit.2011.07.003. Epub 2011 Oct 28.
PubMed 22035624Wylde V, Trela-Larsen L, Whitehouse MR, Blom AW. Preoperative psychosocial risk factors for poor outcomes at 1 and 5 years after total knee replacement. Acta Orthop. 2017 Oct;88(5):530-536. doi: 10.1080/17453674.2017.1334180. Epub 2017 May 31.
PubMed 28562150
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Mindfulness Meditation for Total Knee Arthroplasty: A Pilot Study
- ClinicalTrials.gov ID
- NCT06180486
- Acronym / sponsor ID
- 2023-2131
- Conditions
- Total Knee Replacement, Mediation, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 22 Dec 2023 (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.
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention can train resilience. The main questions it aims to answer are:
- Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery?
- Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study?
- Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls? Can preoperative a mindfulness meditation intervention train resilience (as measured by increased resilience score)?
Participants will be randomly assigned to be in the intervention group or the waitlist control group. The intervention group gets the mindfulness mediation intervention prior to their day of surgery, and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery.
The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days.
Detailed description
This study will investigate the effect of a preoperative mindfulness meditation intervention (MMI) on outcomes for total knee arthroplasty (TKA) patients at the Hospital for Special Surgery in a randomized controlled trial. Mindfulness meditation is a practice well-known to psychology research based on sustained attention on the present and a non-judgment of one's current situation. It has been used for numerous psychological issues including stress, anxiety, and depression. This intervention group will be compared against a waitlist control group (patients will be told they are on a waitlist to receive the mindfulness intervention, which will occur after data collection has finished for their group). This control has been utilized in several mindfulness meditation studies.
Measures of anxiety, depression, resilience, pain and pain unpleasantness, and overall physical and mental health will be taken after randomization, but before the intervention (or being told they are on the waitlist). Overall physical and mental health measures will also be taken on the day of surgery and final surveys will be collected at 90 days post-op.
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention can train resilience. The main questions it aims to answer are:
- Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery?
- Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study?
- Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls? Can preoperative a mindfulness meditation intervention train resilience (as measured by increased resilience score)?
Participants will be randomly assigned to be in the intervention group or the waitlist control group. The intervention group gets the mindfulness mediation intervention prior to their day of surgery, and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery.
The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial of two groups, intervention vs waitlist control
| Arm | Type | Receives |
|---|---|---|
| Waitlist control: Receive MMI After 90 days | Other | Other: Mindfulness Meditation InterventionThe waitlist control group will allow for comparison of those who had access to the mindfulness meditation intervention (MMI) prior to surgery to those who did not. This group will be given the mindfulness meditation intervention 90 days after their surgery when all study questionnaires are complete. Up until 90-days, they will be asked the same questionnaires as the intervention group aside from the MMI practice survey and the exit survey. They will then be given the exit survey 2 weeks after receiving the MMI. This is done to ensure that both groups receive the potential benefit of the teachings and to deter patient dropout for those interested in the study because of wanting to receive the mindfulness training. |
| Intervention: Receive MMI before their day of surgery | Experimental | Other: Mindfulness Meditation InterventionThe intervention group will be given the mindfulness meditation intervention (MMI) 1 week prior to their day of surgery. Up until 90-days, they will be asked the same questionnaires as the waitlist control group, with the addition of the MMI practice survey and the exit survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients undergoing primary total knee arthroplasty with a participating surgeon
- Patients on these medications for anxiety/depression: Fluoxetine, Paroxetine, Citalopram, Escitalopram, Sertraline, Fluvoxamine, Venlafaxine, Duloxetine, Levomilnacipran, Desvenlafaxine, Bupropion, Mirtazapine, Amitriptyline, Nortriptyline, Clonazepam, Alprazolam, Lorazepam, Diazepam, Oxazepam, Chlordiazepoxide
- Patients receiving intraoperative auricular acupuncture as part of participating surgeon's preferred anesthetic care
- Patients fluent in English
- ASA I-III
Key exclusion criteria (8 listed)
- Patient not fluent in English (inability to understand the intervention video will likely affect ability to utilize the mindfulness techniques taught)
- Pediatric patients < 18 years of age
- Patients with contraindications to intra-op protocol
- Patients with contraindications to auricular acupuncture (non-native ear, active ear infection, gauges in the ears)
- Patients unable/unwilling to participate in the questionnaires or view the scripted intervention
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 |
|---|---|---|
| Mindfulness Meditation InterventionThe mindfulness intervention is a scripted, ~12min audio recording based on core tenets of mindfulness meditation and contextualized for patients undergoing total knee arthroplasty. It teaches sustained attention on the present, body awareness, acceptance of the body's current state, and transformational strategies to cope with emotional or physical stimuli as they arise. It has been created by the study team based on the teachings of Jon Kabat Zinn (founder of mindfulness meditation) and the PI's history teaching yoga and meditation. Patients will be encouraged to review the audio recording once a week. | Other | Intervention: Receive MMI before their day of surgery, Waitlist control: Receive MMI After 90 days |
Primary outcome
Overall mental health score
Time frame: 1 week prior to surgery to post operative day 90
PROMIS Mental Health Questionnaire is to assess general mental health in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questionsare excellent, very good, good, fair, or poor.
Anxiety
Time frame: 1 week prior to surgery to post operative day 90
Generalized Anxiety Disorder Assessment (GAD-7) is used to assess severe anxiety in patients 1 Week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are not at all sure, several days, over half the days, or nearly every day.
Depression
Time frame: 1 week prior to surgery to post operative day 90
The Patient Health Questionnaire (PHQ-9) is to assess depression in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are not at all, Several days, more than half the days, and nearly every day.
Overall physical health scores
Time frame: 1 week prior to surgery to post operative day 90
PROMIS Physical Health Questionnaire is used to assess general physical health in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are excellent, very good, good, fair, or poor.
Knee health
Time frame: 1 week prior to surgery to pre operative holding
The KOOS-JR questionnaire will assess knee health after a total knee replacement surgery 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are none, mild, moderate, severe, or extreme.
MMI Practice Survey
Time frame: pre-operative holding to post-operative day 90
The mindfulness meditation intervention practice survey helps to assess enrollment, retention, intervention completion and use measured by time to full enrollment, dropout number/proportion, number of MMI views/uses. The MMI practice survey is asked to the intervention group in pre-operative holding, post-operative day 14 and post-operative day 90. There are several different responses to these questions. These responses include yes or no; from 1-5+; emotional destress or physical pain; Not at all, somewhat improved, improved, or greatly improved.
Exit Survey
Time frame: pre-operative holding to post-operative day 90
The exit survey is used to assess ease and helpfulness of the mindfulness meditation intervention to the patients. This is asked to the intervention group in pre-operative holding, post-operative day 14 and post-operative day 90. This survey includes several different respnses to its questions. Responses include; open ended responses; yes or no; < 1 week, 1-2 weeks, 3-4 weeks, or 4+ weeks.
5 secondary outcomes
Pain outcomes of patients
Time frame: 1 week prior to surgery to post operative day 90
Numerical Rating Scale (NRS)
Time frame: 1 week prior to surgery to post operative day 90
Resilience training
Time frame: 1 week prior to surgery to post operative day 90
Patient satisfaction
Time frame: Post operative day 14
Pain catastrophizing scale
Time frame: 1 week prior to surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 35251437Cheng SI, Kelleher DC, DeMeo D, Zhong H, Birch G, Ast MP. Intraoperative Acupuncture as Part of a Multimodal Analgesic Regimen to Reduce Opioid Usage After Total Knee Arthroplasty: A Prospective Cohort Trial. Med Acupunct. 2022 Feb 1;34(1):49-57. doi: 10.1089/acu.2021.0072. Epub 2022 Feb 14.
- Background: PubMed 32078885Denkova E, Zanesco AP, Rogers SL, Jha AP. Is resilience trainable? An initial study comparing mindfulness and relaxation training in firefighters. Psychiatry Res. 2020 Mar;285:112794. doi: 10.1016/j.psychres.2020.112794. Epub 2020 Jan 16.
- Background: PubMed 33449510Hanley AW, Gililland J, Erickson J, Pelt C, Peters C, Rojas J, Garland EL. Brief preoperative mind-body therapies for total joint arthroplasty patients: a randomized controlled trial. Pain. 2021 Jun 1;162(6):1749-1757. doi: 10.1097/j.pain.0000000000002195.
- Background: PubMed 23358576Hirschmann MT, Testa E, Amsler F, Friederich NF. The unhappy total knee arthroplasty (TKA) patient: higher WOMAC and lower KSS in depressed patients prior and after TKA. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2405-11. doi: 10.1007/s00167-013-2409-z. Epub 2013 Jan 29.
- Background: PubMed 29080597Hofmann SG, Gomez AF. Mindfulness-Based Interventions for Anxiety and Depression. Psychiatr Clin North Am. 2017 Dec;40(4):739-749. doi: 10.1016/j.psc.2017.08.008. Epub 2017 Sep 18.
- Background: PubMed 30121151Jones AR, Al-Naseer S, Bodger O, James ETR, Davies AP. Does pre-operative anxiety and/or depression affect patient outcome after primary knee replacement arthroplasty? Knee. 2018 Dec;25(6):1238-1246. doi: 10.1016/j.knee.2018.07.011. Epub 2018 Aug 16.
- Background: PubMed 22532699Judge A, Arden NK, Cooper C, Kassim Javaid M, Carr AJ, Field RE, Dieppe PA. Predictors of outcomes of total knee replacement surgery. Rheumatology (Oxford). 2012 Oct;51(10):1804-13. doi: 10.1093/rheumatology/kes075. Epub 2012 Apr 24.
- Background: PubMed 30983980Kwak S, Lee TY, Jung WH, Hur JW, Bae D, Hwang WJ, Cho KIK, Lim KO, Kim SY, Park HY, Kwon JS. The Immediate and Sustained Positive Effects of Meditation on Resilience Are Mediated by Changes in the Resting Brain. Front Hum Neurosci. 2019 Mar 26;13:101. doi: 10.3389/fnhum.2019.00101. eCollection 2019.
- Background: PubMed 31278038Magaldi RJ, Staff I, Stovall AE, Stohler SA, Lewis CG. Impact of Resilience on Outcomes of Total Knee Arthroplasty. J Arthroplasty. 2019 Nov;34(11):2620-2623.e1. doi: 10.1016/j.arth.2019.06.008. Epub 2019 Jun 12.
- Background: PubMed 34297704Sharma AK, Elbuluk AM, Gkiatas I, Kim JM, Sculco PK, Vigdorchik JM. Mental Health in Patients Undergoing Orthopaedic Surgery: Diagnosis, Management, and Outcomes. JBJS Rev. 2021 Jul 23;9(7). doi: 10.2106/JBJS.RVW.20.00169.
- Background: PubMed 30988126Singh JA, Yu S, Chen L, Cleveland JD. Rates of Total Joint Replacement in the United States: Future Projections to 2020-2040 Using the National Inpatient Sample. J Rheumatol. 2019 Sep;46(9):1134-1140. doi: 10.3899/jrheum.170990. Epub 2019 Apr 15.
- Background: PubMed 22035624Vissers MM, Bussmann JB, Verhaar JA, Busschbach JJ, Bierma-Zeinstra SM, Reijman M. Psychological factors affecting the outcome of total hip and knee arthroplasty: a systematic review. Semin Arthritis Rheum. 2012 Feb;41(4):576-88. doi: 10.1016/j.semarthrit.2011.07.003. Epub 2011 Oct 28.
- Individual participant dataSharing planned: No
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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.
Christopher Li, MD principal investigator
Hospital for Special Surgery, New York
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 Intervention in people with Total Knee Replacement and Mediation, run by Hospital for Special Surgery, New York at 1 site in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 2 Feb 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mental health score (time frame: 1 week prior to surgery to post operative day 90). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06180486, which also lists 13 linked publications.
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 2 Feb 2026.