Anxiety Acute, Pain, Acute
Conditions
Brief summary
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.
Interventions
BEHAVIORALMindfulness + Meaning Making Questions
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.
BEHAVIORALMindfulness + Implementation Questions
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.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18, * Underwent joint arthroplasty of the knee or hip
Exclusion criteria
* Inability to read English * Cognitive impairment preventing completion of study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 unpleasant, 10=The most unpleasant pain imaginable) numeric rating scale. Higher scores indicate greater pain unpleasantness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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=No pain, 10=Pain as bad as you can imagine) 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 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. |
| 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=Anxiety as bad as you can imagine) numeric rating scale. Higher scores indicate greater anxiety. |
Countries
United States
Contacts
CONTACTAdam Hanley
Outcome results
None listed