The Effect of Mindfulness Training Before Primary Total Joint Arthroplasty on Sleep Quality

NCT05295004 | Unknown

• 1 other identifier: 1845025
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is the determine whether a 15 minute Mindfulness Meditation (MM) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (TJA) results in any improvement in Pittsburg Sleep Quality Index (PSQI) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively.

Conditions

Sleep Disturbance; Arthropathy

Outcome Measures

Primary Outcomes (1)

• Pittsburg Sleep Quality Index score

  Improvement in Pittsburg Sleep Quality Index (PSQI) score, Scale is 0 to 21, higher score is worse outcome.

  Change from Pre-Op to 2, 6 and 12 weeks post op.

Secondary Outcomes (5)

• Visual Analog Score

  Change from Pre-Op to 2, 6 and 12 weeks post op.

• Epworth Sleepiness Scale

  Change from Pre-Op to 2, 6 and 12 weeks post op.

• Knee Injury and Osteoarthritis Outcome Scores JR

  Change from Pre-Op to 2, 6 and 12 weeks post op.

• Knee Society Score (KSS)

  Change from Pre-Op to 6 Weeks post op.

• Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD)

  Change from Pre-Op to 2, 6 and 12 weeks post op.

Study Arms (3)

No Treatment

NO INTERVENTION

Patient will receive no mindfulness meditation training.

Mindfulness at Pre-Op

EXPERIMENTAL

Patient will receive a one time training at their pre-operative appointment.

Behavioral: Mindfulness Meditation Training

Multiple Mindfulness Meditation

EXPERIMENTAL

Mindfulness Video Training at Pre-Op, 1 Day Prior to surgery, 3 day's Post OP and 2 Weeks Post OP.

Behavioral: Mindfulness Meditation Training

Interventions

Mindfulness Meditation Training BEHAVIORAL

Patient will watch a 10 minute video on how to use mindfulness meditation to help with sleep after a total joint replacement procedure.

Mindfulness at Pre-Op; Multiple Mindfulness Meditation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary unilateral total joint arthroplasty at Colorado Joint Replacement
• Between the ages of 18 and 90 years old will be included in the study.

You may not qualify if:

• Simultaneous total joint arthroplasty
• Uni-compartmental knee arthroplasty
• Revision surgery for infection, fracture or other indication.
• History of Drug or Alcohol Abuse
• Patients who are unable to present at a standard pre-operative appointment within 4 weeks prior to scheduled surgery will also be excluded, as the MM intervention would not be possible to administer.

Sponsors & Collaborators

• Colorado Joint Replacement: lead

Study Sites (1)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

RECRUITING

Related Publications (13)

• Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.

  PMID: 26163057 RESULT

• Chen AF, Orozco FR, Austin LS, Post ZD, Deirmengian CA, Ong AC. Prospective Evaluation of Sleep Disturbances After Total Knee Arthroplasty. J Arthroplasty. 2016 Jan;31(1):330-2. doi: 10.1016/j.arth.2015.07.044. Epub 2015 Aug 30.

  PMID: 26455403 RESULT

• Er MS, Altinel EC, Altinel L, Erten RA, Eroglu M. An assessment of sleep quality in patients undergoing total knee arthroplasty before and after surgery. Acta Orthop Traumatol Turc. 2014;48(1):50-4. doi: 10.3944/AOTT.2014.3163.

  PMID: 24643100 RESULT

• Chhangani BS, Roehrs TA, Harris EJ, Hyde M, Drake C, Hudgel DW, Roth T. Pain sensitivity in sleepy pain-free normals. Sleep. 2009 Aug;32(8):1011-7.

  PMID: 19725252 RESULT

• Manrique J, Gomez MM, Parvizi J. Stiffness after total knee arthroplasty. J Knee Surg. 2015 Apr;28(2):119-26. doi: 10.1055/s-0034-1396079. Epub 2014 Dec 16.

  PMID: 25513992 RESULT

• Dowsey M, Castle D, Knowles S, Monshat K, Salzberg M, Nelson E, Dunin A, Dunin J, Spelman T, Choong P. The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: A randomised controlled trial. Complement Ther Med. 2019 Oct;46:195-201. doi: 10.1016/j.ctim.2019.08.010. Epub 2019 Aug 12.

  PMID: 31519279 RESULT

• 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 RESULT

• Kiran U, Ladha S, Makhija N, Kapoor PM, Choudhury M, Das S, Gharde P, Malik V, Airan B. The role of Rajyoga meditation for modulation of anxiety and serum cortisol in patients undergoing coronary artery bypass surgery: A prospective randomized control study. Ann Card Anaesth. 2017 Apr-Jun;20(2):158-162. doi: 10.4103/aca.ACA_32_17.

  PMID: 28393774 RESULT

• Packiasabapathy S, Susheela AT, Mueller A, Patxot M, Gasangwa DV, O'Gara B, Shaefi S, Marcantonio ER, Yeh GY, Subramaniam B. Guided meditation as an adjunct to enhance postoperative recovery after cardiac surgery: study protocol for a prospective randomized controlled feasibility trial. Trials. 2019 Jan 11;20(1):39. doi: 10.1186/s13063-018-3103-8.

  PMID: 30635064 RESULT

• Chavez JL, Porucznik CA, Gren LH, Guan J, Joyce E, Brodke DS, Dailey AT, Mahan MA, Hood RS, Lawrence BD, Spiker WR, Spina NT, Bisson EF. The Impact of Preoperative Mindfulness-Based Stress Reduction on Postoperative Outcomes in Lumbar Spine Degenerative Disease: 3-Month and 12-Month Results of a Pilot Study. World Neurosurg. 2020 Jul;139:e230-e236. doi: 10.1016/j.wneu.2020.03.186. Epub 2020 Apr 9.

  PMID: 32278820 RESULT

• Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. Sleep. 2014 Sep 1;37(9):1553-63. doi: 10.5665/sleep.4010.

  PMID: 25142566 RESULT

• Rusch HL, Rosario M, Levison LM, Olivera A, Livingston WS, Wu T, Gill JM. The effect of mindfulness meditation on sleep quality: a systematic review and meta-analysis of randomized controlled trials. Ann N Y Acad Sci. 2019 Jun;1445(1):5-16. doi: 10.1111/nyas.13996. Epub 2018 Dec 21.

  PMID: 30575050 RESULT

• Shakya H, Wang D, Zhou K, Luo ZY, Dahal S, Zhou ZK. Prospective randomized controlled study on improving sleep quality and impact of zolpidem after total hip arthroplasty. J Orthop Surg Res. 2019 Sep 3;14(1):289. doi: 10.1186/s13018-019-1327-2.

  PMID: 31481074 RESULT

MeSH Terms

Conditions

Parasomnias; Joint Diseases

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Musculoskeletal Diseases

Study Officials

• Jason M Jennings, MD, DPT

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roseann Johnson, BS, CCRP

CONTACT

7203552190; roseannjohnson@centura.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Model Details: Randomize à Arm 1 (No Treatment), Arm 2 (Mindfulness Video @ Pre-Op), Arm 3 (Mindfulness Video @ Pre-Op, 1 Day Prior to surgery, 3 day's Post OP, 2 Weeks Post OP)

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: March 15, 2022
• Primary Completion: March 15, 2024
• Study Completion: July 31, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

US (1)