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Completed

NCT Number: NCT04800354

Brief Nurse-led Mindfulness Based Intervention

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The feasibility, acceptability, and clinical effects of the nurse-led, very brief, preoperative mindfulness based intervention for hip and knee replacement patients will be investigated relative to nurse-led preoperative pain psychoeducation.

A secondary sub-analysis will compare two different styles of mindfulness practice (mindfulness of breath vs. mindfulness of pain) relative to preoperative pain psychoeducation.

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Key information

Conditions

Pain Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) Age ≥18,
  • 2) Scheduled to undergo unilateral total knee arthroplasty

Exclusion criteria

  • 1) Cognitive impairment preventing completion of study procedures.
  • 2) Current cancer diagnosis,
  • 3) Contralateral knee replaced in the previous 3 months,
  • 4) Intent to have contralateral knee replaced or other, additional surgical procedure during the study period,
  • 5) Intent to add new pain treatments during the study period (except for what is part of the study),
  • 6) Other unstable illness judged by medical staff to interfere with study treatment.

Treatment and study plan

Nurse-led Mindfulness Based Intervention

Behavioral

Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then have them listen to a very brief (1 minute 30 second) guided mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time they experience intense pain or take pain medication before and after surgery.

Nurse-led Pain Psychoeducation

Behavioral

Nurses will provide psychoeducation about pain along with common pain coping strategies, such as rest, ice, and elevation, for use any time they experience intense pain or take pain medication before and after surgery.

Primary outcomes

  1. Change in Pain Intensity Numeric Rating Scale

    Time frame: baseline and after the 15 minute preoperative nurse visit

    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.

Secondary outcomes

  1. Change in Pain Unpleasantness Numeric Rating Scale

    Time frame: baseline and after the 15 minute preoperative nurse visit

    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

  2. Change in Pain Medication Desire Numeric Rating Scale

    Time frame: baseline and after the 15 minute preoperative nurse visit

    Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.

  3. Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0

    Time frame: During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment

    The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale.

    T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score better physical functioning.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Brief Nurse-led Mindfulness Based Intervention Among Patients Scheduled for Knee and Hip Replacement Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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