App Delivered Brief Mindfulness Intervention for Surgical Patients

Not Applicable

Recruiting

• Conditions: Pain; Depressive State; Anxiety State
• Interventions: Behavioral: Mindful Savoring; Behavioral: Breath Counting; Behavioral: Body Scan; Behavioral: Mindful Breathing; Behavioral: Mindfulness of Pain

• Registration Number: NCT05433389
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-21
• Study Start: 2022-06-22
• Study First Posted: 2022-06-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 305

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindful Savoring	Mindful Savoring	-
Breath Counting	Breath Counting	-
Body Scan	Body Scan	-
Mindful Breathing	Mindful Breathing	-
Mindfulness of Pain	Mindfulness of Pain	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Unpleasantness	Immediately before to after 5-minute audio recording	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

Name	Time	Method
Change in Pain Intensity	Immediately before to after 5-minute audio recording	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	Immediately before to after 5-minute audio recording	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.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States