NCT04520958

Brief Summary

This was a single site, three-arm, parallel group randomized clinical trial that compared the effect of three preoperative psychosocial interventions on knee and hip replacement patients' preoperative pain intensity and postoperative pain intensity, pain unpleasantness, and opioid use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
Last Updated

August 27, 2020

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

August 13, 2020

Last Update Submit

August 24, 2020

Conditions

Pain, AcutePain, JointPain

Outcome Measures

Primary Outcomes (2)

  • Change in Preoperative Pain Intensity

    Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.

    Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)

  • Change in Postoperative Pain Intensity

    Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.

    Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.

Secondary Outcomes (2)

  • Change in Postoperative Pain Unpleasantness

    Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.

  • Change in Postoperative Opioid Use

    Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.

Other Outcomes (3)

  • Change in Self-Transcendent State

    Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)

  • Patient Confidence

    Completed immediately after the preoperative intervention

  • Patient Intent

    Completed immediately after the preoperative intervention

Study Arms (3)

Mindfulness of Breath

EXPERIMENTAL
Behavioral: Mindfulness of Breath

Mindfulness of Pain

EXPERIMENTAL
Behavioral: Mindfulness of Pain

Cognitive-Behaviorally Based Pain Psychoeducation

ACTIVE COMPARATOR
Behavioral: Cognitive-Behaviorally Based Pain Psychoeducation

Interventions

Mindfulness of BreathBEHAVIORAL

Mindfulness of Breath consisted of instruction in focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.

Mindfulness of Breath
Mindfulness of PainBEHAVIORAL

Mindfulness of Pain consisted of instruction in how to (1) zoom in to deconstruct pain into its constituent physical sensations and precisely map each sensation's spatial location, (2) use mindful breathing to zoom out and broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that were absent of sensation and pleasant sensations), and (3) shift attention from unpleasant sensations to neutral/pleasant sensations or experiences.

Mindfulness of Pain
Cognitive-Behaviorally Based Pain PsychoeducationBEHAVIORAL

Cognitive-Behaviorally Based Pain Psychoeducation consisted of psychoeducation about the link between thoughts, emotions, and behavior and provided instruction in the use logic to dispute maladaptive thoughts about pain that might otherwise exacerbate pain and distress.

Cognitive-Behaviorally Based Pain Psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking males or females.
  • years old or older
  • Patients within the University of Utah Hospital system
  • Patients attending Joint Academy to prepare for either hip or knee replacement surgery

You may not qualify if:

  • Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • Hanley AW, Gililland J, Garland EL. To be mindful of the breath or pain: Comparing two brief preoperative mindfulness techniques for total joint arthroplasty patients. J Consult Clin Psychol. 2021 Jul;89(7):590-600. doi: 10.1037/ccp0000657. Epub 2021 Jun 24.

    PMID: 34165999DERIVED

MeSH Terms

Conditions

Acute PainArthralgiaPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 20, 2020

Study Start

October 29, 2019

Primary Completion

March 10, 2020

Study Completion

August 13, 2020

Last Updated

August 27, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)