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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness | Experimental | 15 minute mindfulness session |
|
| Suggestion | Experimental | 15 minute therapeutic suggestion session |
|
| Psychoeducation | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable. | Immediately prior to and following intervention |
| Pain Unpleasantness Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable. | Immediately prior to and following intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Medication Desire Numeric Rating Scale | 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. | Immediately prior to and following intervention |
| Anxiety Numeric Rating Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Present Moment Awareness Numeric Rating Scale (Manipulation Check) | 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. | Immediately prior to and following intervention |
| Decentering Numeric Rating Scale (Manipulation Check) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34165999 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2017 | Sep 27, 2019 | Prot_SAP_000.pdf |
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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 |
| D013404 | Suggestion |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Clinical assessors were masked at postoperative follow-up
| 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. |
|
Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious. |
| Immediately prior to and following intervention |
| 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 better physical functioning. | During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment. |
| Nondual Awareness Dimensional Assessment - State | 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. | Immediately prior to and following intervention |
| Sensation Manikin Body Sensation Report | 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. | 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. |
| Immediately prior to and following intervention |
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |