| Registry | NCT03665727, acronym Mind-Body JRA |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 727 (Actual) |
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| Sponsor | University of Utah (Other) |
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| Conditions | Acute Pain |
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| Interventions | Mindfulness, Suggestion, Psychoeducation (Behavioral) |
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| Dates | start 2018-06-04, primary completion 2019-09-23, completion 2019-09-23, first posted 2018-09-11, last updated 2020-05-27 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Acute Pain All trials of Mindfulness All trials of Suggestion
-Summary
The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Mindfulness | Experimental | Behavioral: Mindfulness | 15 minute mindfulness session |
| Suggestion | Experimental | Behavioral: Suggestion | 15 minute therapeutic suggestion session |
| Psychoeducation | Active comparator | Behavioral: Psychoeducation | 15 minute psychoeducation session |
| Usual Care | No intervention | | The usual care comparison group was comprised of patients who underwent total joint arthroplasty of the hip or knee at the same academic medical center during the study period but who did not attend Joint Academy. |
- Mindfulness (Behavioral): The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.
- Suggestion (Behavioral): The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
- Psychoeducation (Behavioral): The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
+Outcome measures
Primary outcomes
- Pain Intensity Numeric Rating Scale [Immediately prior to and following intervention]: Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
- Pain Unpleasantness Numeric Rating Scale [Immediately prior to and following intervention]: Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Secondary outcomes
- Pain Medication Desire Numeric Rating Scale [Immediately prior to and following intervention]: Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.
- Anxiety Numeric Rating Scale [Immediately prior to and following intervention]: Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious.
- Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0 [During the 6 weeks prioir 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 better physical functioning.
- Nondual Awareness Dimensional Assessment - State [Immediately prior to and following intervention]: Three Likert scale item ranging from 0-30, with 0 indicating no nondual awareness and 10 representing complete nondual awareness. Items can also be used individually. Item one is a single Likert scale item ranging from 0-10, with 0 indicating no relational unity and 10 representing complete relational unity. Item two is a single Likert scale item ranging from 0-10, with 0 indicating no annihilational unity and 10 representing complete annihilational unity. Item three is a single Likert scale item ranging from 0-10, with 0 indicating no bliss and 10 representing complete bliss.
- Sensation Manikin Body Sensation Report [Immediately prior to and following intervention]: The ratio of pleasant to unpleasant bodily sensations reported on a sensation manikin. Ratio scores below 1 indicate unpleasant sensations predominate in the body and ratio scores above 1 indicate pleasant scores predominate.
Other outcomes
- Present Moment Awareness Numeric Rating Scale (Manipulation Check) [Immediately prior to and following intervention]: Single Likert scale item ranging from 0-10, with 0 indicating no awareness of the present and 10 representing complete awareness of the present moment.
- Decentering Numeric Rating Scale (Manipulation Check) [Immediately prior to and following intervention]: Single Likert scale item ranging from 0-10, with 0 indicating no decentering and 10 representing a completely decentered perspective.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* English-speaking males or females
* 18 years old or older
* patients within the University of Utah Hospital system
* patients attending the Joint Replacement Academy to prepare for either hip or knee replacement surgery
Exclusion Criteria:
* Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
+Locations (1)
| Facility | City | Country | Status |
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| University of Utah | Salt Lake City, Utah | United States | |
+Publications
- Results publication: Hanley AW, Gililland J, Garland EL. To be mindful of the breath or pain: Comparing two brief preoperative mindfulness techniques for total joint arthroplasty patients. J Consult Clin Psychol. 2021 Jul;89(7):590-600. doi: 10.1037/ccp0000657. Epub 2021 Jun 24. PMID 34165999
+Study documents