App Delivered Brief Mindfulness Intervention for Surgical Patients

Pain Clinical Trial

Official title:

App Delivered Brief Mindfulness Intervention for Knee or Hip Replacement Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433389
• Other study ID #: 00085446 AM_00032203
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: University of Utah
• Contact: Adam W Hanley, PhD
• Phone: 8012134191
• Email: adam.hanley[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 305
• Est. completion date: September 1, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety State
• Depression
• Depressive State
• Pain

Intervention

Behavioral:
• Breath Counting
Patients will listen to a 5-minute, audio-recorded breath counting practice.
• Body Scan
Patients will listen to a 5-minute, audio-recorded body scan practice.
• Mindful Breathing
Patients will listen to a 5-minute, audio-recorded mindful breathing practice.
• Mindfulness of Pain
Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.
• Mindful Savoring
Patients will listen to a 5-minute, audio-recorded mindful savoring practice.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Anxiety	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.	Immediately before to after 5-minute audio recording
Other	Change in Depression	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.	Immediately before to after 5-minute audio recording
Other	Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0	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.	During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
Primary	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.	Immediately before to after 5-minute audio recording
Secondary	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.	Immediately before to after 5-minute audio recording
Secondary	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.	Immediately before to after 5-minute audio recording