Brief Nurse-led Mindfulness Based Intervention

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT04800354
• Collaborator: (none)
• Enrollment: 127
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.6
• Patients Per Site Per Month: 12

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Osteoarthritis, Knee; Osteoarthritis, Hip	Behavioral: Nurse-led Mindfulness Based Intervention; Behavioral: Nurse-led Pain Psychoeducation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Brief Nurse-led Mindfulness Based Intervention Among Patients Scheduled for Knee and Hip Replacement Surgery
• Actual Study Start Date: Feb 22, 2021
• Actual Primary Completion Date: May 20, 2021
• Actual Study Completion Date: Jan 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nurse-led Mindfulness Based Intervention	Behavioral: Nurse-led Mindfulness Based Intervention; 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.; Behavioral: Nurse-led Pain Psychoeducation; 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.
Active Comparator: Nurse-led Pain Psychoeducation	Behavioral: Nurse-led Pain Psychoeducation; 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.

Outcome Measures

Primary Outcome Measures

1. Change in Pain Intensity Numeric Rating Scale [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 Outcome Measures

1. Change in Pain Unpleasantness Numeric Rating Scale [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adam Hanley, Assistant Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT04800354
• Other Study ID Numbers: IRB_00085446: AM_00040605
• First Posted: Mar 16, 2021
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip

Study Results

No Results Posted as of Jan 11, 2022