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This single-site, two-arm, parallel-group randomized controlled trial will enroll adults undergoing total knee or hip replacement surgery. Two days after surgery, participants will complete a brief guided mindful breathing practice delivered by text message and will then be randomized to receive either personalized meaning-making questions or implementation-focused questions. The trial will evaluate whether personalized meaning-making questions enhance the clinical effects of the mindfulness practice on acute pain, pain unpleasantness, anxiety, desire for pain medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meaning Making Questions | Experimental |
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| Implementation Questions | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness + Meaning Making Questions | Behavioral | Participants randomized to this arm will receive a brief, text-message-delivered mindfulness intervention two days after total knee or hip replacement surgery. The intervention consists of a 5-minute guided mindful breathing practice that begins with visually paced breathing and then transitions to audio-guided mindful awareness of the breath. Immediately afterward, participants will answer personalized meaning-making questions designed to help them reflect on what stood out during the practice and how that experience related to their pain, relaxation, or coping. |
| 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 unpleasant, 10=The most unpleasant pain imaginable) numeric rating scale. Higher scores indicate greater pain unpleasantness. | Immediately before to after 5-minute audio recording |
| 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=No pain, 10=Pain as bad as you can imagine) numeric rating scale. Higher scores indicate greater pain intensity. | Immediately before to after 5-minute audio recording |
| Change in Pain Medication Desire |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Hanley | Contact | 850-645-9557 | adam.hanley@utah.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Mindfulness + Implementation Questions | Behavioral | Participants randomized to this arm will receive a brief, text-message-delivered mindfulness intervention two days after total knee or hip replacement surgery. The intervention consists of a 5-minute guided mindful breathing practice that begins with visually paced breathing and then transitions to audio-guided mindful awareness of the breath. Immediately afterward, participants will answer two implementation-focused questions about how the intervention could best be delivered or used in postoperative care, such as preferred timing, length, or mode of delivery. |
|
Single item assessing pain unpleasantness ("How much do you want to take pain medicine?") scored on an 11-point (0=Not at all, 10=Extremely) numeric rating scale. Higher scores indicate greater desire for pain medicine. |
| Immediately before to after 5-minute audio recording |
| 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=Anxiety as bad as you can imagine) numeric rating scale. Higher scores indicate greater anxiety. | Immediately before to after 5-minute audio recording |
| During the 6 weeks prior to surgery and at the 2-, 6-, and 12-week outpatient follow-up appointments |