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

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295004
• Other study ID #: 1845025
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: Colorado Joint Replacement
• Contact: Roseann Johnson, BS, CCRP
• Phone: 7203552190
• Email: roseannjohnson[@]centura.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. We hypothesize that patients in the MM cohort will have lower PSQI scores, indicating higher sleep quality, at both post-operative time points. Secondary aims include characterizing differences between cohorts in Visual Analog Scale (VAS) for pain, Epworth Sleepiness Scale (ESS) scores, Patient Reported Outcome Measurement Information System - Sleep Disturbance - Short Form, and Knee Injury and Osteoarthritis Outcome Scores (KOOS) at 2, 6 and 12 weeks following TJA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: July 31, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arthropathy
• Dyssomnias
• Joint Diseases
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• Mindfulness Meditation Training
Patient will watch a 10 minute video on how to use mindfulness meditation to help with sleep after a total joint replacement procedure.

Locations

Country	Name	City	State
United States	Colorado Joint Replacement	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado Joint Replacement

Country where clinical trial is conducted

United States, 

References & Publications (13)

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 D — View Citation

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. — View Citation

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. — View Citation

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. Comple — View Citation

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. — 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

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 stu — View Citation

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. — View Citation

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; — View Citation

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. — View Citation

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 randomiz — View Citation

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/n — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Score	Improvement in Visual Analog Score (VAS), Scale is 1 to 10, higher score is worse outcome	Change from Pre-Op to 2, 6 and 12 weeks post op.
Secondary	Epworth Sleepiness Scale	Improvement in Epworth Sleepiness Scale (ESS), Scale is 0 to 24, higher score is worse outcome	Change from Pre-Op to 2, 6 and 12 weeks post op.
Secondary	Knee Injury and Osteoarthritis Outcome Scores JR	Improvement in Knee Injury and Osteoarthritis Outcome Scores JR (KOOS JR), Scale is 1 to 100, lower score is worse outcome	Change from Pre-Op to 2, 6 and 12 weeks post op.
Secondary	Knee Society Score (KSS)	Improvement in Knee Society Score (KSS), Scale is 0 to 100, lower score is worse outcome	Change from Pre-Op to 6 Weeks post op.
Secondary	Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD)	Improvement in Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD), Scale is 8 to 40, higher score is worse outcome	Change from Pre-Op to 2, 6 and 12 weeks post op.