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Sleep DisturbanceNCT05295004

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

A study testing Mindfulness Meditation Training in people with Sleep Disturbance and Arthropathy, run by Colorado Joint Replacement at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Sleep Disturbance, Arthropathy
What is being tested?
Mindfulness Meditation Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
282 participants
Where
1 siteUnited States
Study dates
15 Mar 2022to 5 Nov 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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Colorado Joint Replacement

    Denver, Colorado, 80210

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
Mindfulness Meditation Training
Medical subject headings
Parasomnias, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Meditation TrainingBehavioural

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

Study groups in NCT05295004
Study groupRoleWhat they receive
No TreatmentNo interventionPatient will receive no mindfulness meditation training.
Mindfulness at Pre-OpExperimentalPatient will receive a one time training at their pre-operative appointment.
Receives: Behavioral: Mindfulness Meditation Training
Multiple Mindfulness MeditationExperimentalMindfulness Video Training at Pre-Op, 1 Day Prior to surgery, 3 day's Post OP and 2 Weeks Post OP.
Receives: Behavioral: Mindfulness Meditation Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburg Sleep Quality Index score

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

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

Secondary outcomes (5)

  1. Visual Analog Score

    Improvement in Visual Analog Score (VAS), Scale is 1 to 10, higher score is worse outcome

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

  2. Epworth Sleepiness Scale

    Improvement in Epworth Sleepiness Scale (ESS), Scale is 0 to 24, higher score is worse outcome

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

  3. 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

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

  4. Knee Society Score (KSS)

    Improvement in Knee Society Score (KSS), Scale is 0 to 100, lower score is worse outcome

    Measured: Change from Pre-Op to 6 Weeks post op.

  5. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2022
  2. Study start15 Mar 2022
  3. Primary completion30 Nov 2023
  4. Study completion5 Nov 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295004
Sponsor's protocol ID
1845025
Status last verified
Nov 2026
First submitted
15 Mar 2022
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26163057

  • 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.

    PubMed 26455403

  • 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.

    PubMed 24643100

  • 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.

    PubMed 19725252

  • 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.

    PubMed 25513992

  • 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.

    PubMed 31519279

  • 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.

    PubMed 33449510

  • 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.

    PubMed 28393774

  • 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.

    PubMed 30635064

  • 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.

    PubMed 32278820

  • 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.

    PubMed 25142566

  • 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.

    PubMed 30575050

  • 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.

    PubMed 31481074

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Meditation Training in people with Sleep Disturbance and Arthropathy, run by Colorado Joint Replacement 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 2 inclusion and 5 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 4 Nov 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?

Pittsburg Sleep Quality Index score (time frame: Change from Pre-Op to 2, 6 and 12 weeks post op.). 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 NCT05295004, 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 4 Nov 2026.

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