Mindfulness Meditation Intervention Study

Total Knee Replacement Clinical Trial

Official title:

Preoperative Mindfulness Meditation for Total Knee Arthroplasty: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180486
• Other study ID #: 2023-2131
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Hospital for Special Surgery, New York
• Contact: Angela Puglisi, BS
• Phone: 6467146849
• Email: puglisia[@]hss.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 can train resilience. The main questions it aims to answer are: 1. Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery? 2. Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study? 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)? 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Feasibility
• Mediation
• Total Knee Replacement

Intervention

Other:
• Mindfulness Meditation Intervention
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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Denkova E, Zanesco AP, Rogers SL, Jha AP. Is resilience trainable? An initial study comparing mindfulness and relaxation training in firefighters. Psychiatry Res. 2020 Jan 16;285:112794. doi: 10.1016/j.psychres.2020.112794. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	1 week prior to surgery to post operative day 90
Secondary	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.	1 week prior to surgery to post operative day 90
Secondary	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.	1 week prior to surgery to post operative day 90
Secondary	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.	Post operative day 14
Secondary	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.	1 week prior to surgery