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App Delivered Brief Mindfulness Intervention for Surgical Patients

Primary Purpose

Pain, Anxiety State, Depressive State

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breath Counting
Body Scan
Mindful Breathing
Mindfulness of Pain
Mindful Savoring
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18,
  • Scheduled to undergo total joint arthroplasty of the knee or hip

Exclusion Criteria:

  • Inability to read English
  • Cognitive impairment preventing completion of study procedures

Sites / Locations

  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Breath Counting

Body Scan

Mindful Breathing

Mindfulness of Pain

Mindful Savoring

Arm Description

Outcomes

Primary Outcome Measures

Change in Pain Unpleasantness
Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness.

Secondary Outcome Measures

Change in Pain Intensity
Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity.
Change in Pain Medication Desire
Single item assessing pain unpleasantness ("How much do you want pain medicine?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater desire for pain medicine.

Full Information

First Posted
June 21, 2022
Last Updated
July 5, 2022
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05433389
Brief Title
App Delivered Brief Mindfulness Intervention for Surgical Patients
Official Title
App Delivered Brief Mindfulness Intervention for Knee or Hip Replacement Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
June 21, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This will be a single-site, five-arm, parallel group randomized control trial involving patients undergoing knee or hip replacement surgery. The investigators will compare five different styles of 5-minute, audio-recoded mindfulness practices delivered via app 7 days before to surgery, 2 days before to surgery, 2 days after surgery, and 6 days after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety State, Depressive State

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
305 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breath Counting
Arm Type
Active Comparator
Arm Title
Body Scan
Arm Type
Experimental
Arm Title
Mindful Breathing
Arm Type
Experimental
Arm Title
Mindfulness of Pain
Arm Type
Experimental
Arm Title
Mindful Savoring
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Breath Counting
Intervention Description
Patients will listen to a 5-minute, audio-recorded breath counting practice.
Intervention Type
Behavioral
Intervention Name(s)
Body Scan
Intervention Description
Patients will listen to a 5-minute, audio-recorded body scan practice.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Breathing
Intervention Description
Patients will listen to a 5-minute, audio-recorded mindful breathing practice.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness of Pain
Intervention Description
Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Savoring
Intervention Description
Patients will listen to a 5-minute, audio-recorded mindful savoring practice.
Primary Outcome Measure Information:
Title
Change in Pain Unpleasantness
Description
Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness.
Time Frame
Immediately before to after 5-minute audio recording
Secondary Outcome Measure Information:
Title
Change in Pain Intensity
Description
Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity.
Time Frame
Immediately before to after 5-minute audio recording
Title
Change in Pain Medication Desire
Description
Single item assessing pain unpleasantness ("How much do you want pain medicine?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater desire for pain medicine.
Time Frame
Immediately before to after 5-minute audio recording
Other Pre-specified Outcome Measures:
Title
Change in Anxiety
Description
Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater anxiety.
Time Frame
Immediately before to after 5-minute audio recording
Title
Change in Depression
Description
Single item assessing pain unpleasantness ("How down, depressed, or uninterested in life do you feel?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater depression.
Time Frame
Immediately before to after 5-minute audio recording
Title
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
Description
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 reflects better physical functioning.
Time Frame
During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18, Scheduled to undergo total joint arthroplasty of the knee or hip Exclusion Criteria: Inability to read English Cognitive impairment preventing completion of study procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam W Hanley, PhD
Phone
8012134191
Email
adam.hanley@utah.edu
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam W Hanley, PhD
Phone
801-581-6192
Email
adam.hanley@utah.edu

12. IPD Sharing Statement

Learn more about this trial

App Delivered Brief Mindfulness Intervention for Surgical Patients

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