Mindfulness Meditation Intervention Study

NCT06180486 | Completed

• 1 other identifier: 2023-2131
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 can train resilience. The main questions it aims to answer are:

1. 1.Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery?
2. 2.Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study?
3. 3.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)?

Conditions

Mediation; Feasibility; Total Knee Replacement

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  pre-operative holding to post-operative day 90

Secondary Outcomes (5)

• Pain outcomes of patients

  1 week prior to surgery to post operative day 90

• Numerical Rating Scale (NRS)

  1 week prior to surgery to post operative day 90

• Resilience training

  1 week prior to surgery to post operative day 90

• Patient satisfaction

  Post operative day 14

• Pain catastrophizing scale

  1 week prior to surgery

Study Arms (2)

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.

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.

Other: Mindfulness Meditation Intervention

Interventions

Mindfulness Meditation Intervention OTHER

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.

Intervention: Receive MMI before their day of surgery; Waitlist control: Receive MMI After 90 days

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (13)

• 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.

  PMID: 35251437 BACKGROUND

• Denkova 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.

  PMID: 32078885 BACKGROUND

• Hanley 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.

  PMID: 33449510 BACKGROUND

• Hirschmann 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.

  PMID: 23358576 BACKGROUND

• Hofmann 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.

  PMID: 29080597 BACKGROUND

• Jones 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.

  PMID: 30121151 BACKGROUND

• Judge 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.

  PMID: 22532699 BACKGROUND

• Kwak 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.

  PMID: 30983980 BACKGROUND

• Magaldi 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.

  PMID: 31278038 BACKGROUND

• Sharma 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.

  PMID: 34297704 BACKGROUND

• Singh 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.

  PMID: 30988126 BACKGROUND

• Vissers 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.

  PMID: 22035624 BACKGROUND

• Wylde 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.

  PMID: 28562150 BACKGROUND

MeSH Terms

Conditions

Negotiating

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Christopher Li, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients, research assistants, surgeons, and anesthesiologists are all unblinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial of two groups, intervention vs waitlist control

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: February 2, 2024
• Primary Completion: January 28, 2025
• Study Completion: February 11, 2025
• Last Updated: February 2, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)