Pain, Anxiety State, Depressive State
Conditions
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.
Interventions
BEHAVIORALBreath Counting
Patients will listen to a 5-minute, audio-recorded breath counting practice.
BEHAVIORALBody Scan
Patients will listen to a 5-minute, audio-recorded body scan practice.
BEHAVIORALMindful Breathing
Patients will listen to a 5-minute, audio-recorded mindful breathing practice.
BEHAVIORALMindfulness of Pain
Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.
BEHAVIORALMindful Savoring
Patients will listen to a 5-minute, audio-recorded mindful savoring practice.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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 at all, 10=Very much) 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=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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed