App Delivered Brief Mindfulness Intervention for Surgical Patients

Study Overview
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Brief Summary
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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.

Official Title
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App Delivered Brief Mindfulness Intervention for Knee or Hip Replacement Patients

Conditions
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Pain, Anxiety State, Depressive State

Intervention / Treatment
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* Behavioral: Breath Counting
* Behavioral: Body Scan
* Behavioral: Mindful Breathing
* Behavioral: Mindfulness of Pain
* Behavioral: Mindful Savoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Breath Counting<br> | Behavioral: Breath Counting<br>* Patients will listen to a 5-minute, audio-recorded breath counting practice.<br>|
| Experimental: Body Scan<br> | Behavioral: Body Scan<br>* Patients will listen to a 5-minute, audio-recorded body scan practice.<br>|
| Experimental: Mindful Breathing<br> | Behavioral: Mindful Breathing<br>* Patients will listen to a 5-minute, audio-recorded mindful breathing practice.<br>|
| Experimental: Mindfulness of Pain<br> | Behavioral: Mindfulness of Pain<br>* Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.<br>|
| Experimental: Mindful Savoring<br> | Behavioral: Mindful Savoring<br>* Patients will listen to a 5-minute, audio-recorded mindful savoring practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |