App Delivered Brief Mindfulness Intervention for Surgical Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Breath Counting
|
Behavioral: Breath Counting
Patients will listen to a 5-minute, audio-recorded breath counting practice.
|
| Experimental: Body Scan
|
Behavioral: Body Scan
Patients will listen to a 5-minute, audio-recorded body scan practice.
|
| Experimental: Mindful Breathing
|
Behavioral: Mindful Breathing
Patients will listen to a 5-minute, audio-recorded mindful breathing practice.
|
| Experimental: Mindfulness of Pain
|
Behavioral: Mindfulness of Pain
Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.
|
| Experimental: Mindful Savoring
|
Behavioral: Mindful Savoring
Patients will listen to a 5-minute, audio-recorded mindful savoring practice.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Other Outcome Measures
- Change in Anxiety [Immediately before to after 5-minute audio recording]
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.
- Change in Depression [Immediately before to after 5-minute audio recording]
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.
- 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 reflects better physical functioning.
Eligibility Criteria
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
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.- 00085446 AM_00032203