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New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7 brief explanations of the mind-body connection with variations in cognitive, emotional, or physiology-based explanations. Reactions were measured as resonance (Likert scale) and Self-Assessment Manikins (SAM) for happiness, excitement, and control. Patients also completed demographic and mental and emotional health surveys. Overall 304 patients were included (mean age 49 -17, range 18 to 87; 51% men). Multilevel multivariable linear regression models were constructed to assess factors associated with resonance, happiness, excitement, and control.
Study design the investigators obtained institutional review board approval and prospectively enrolled 308 patients in this cross-sectional study over a 4-month period. All patients were seen at one of four participating orthopaedic offices in a large urban area. the investigators included all new or return orthopaedic patients aged 18 to 89 years old. After the visit with the surgeon, a research assistant not involved in patient care explained the study to the patient and asked them to participate. the investigators obtained a waiver for written consent; completing the questionnaires represented consent.
Outcomes measures Each patient read one of 7 randomly selected explanations for more pain than expected on a tablet. There were 2 cognitively-framed explanations ("the mind is a great story teller"; one positively- and one negatively framed), 2 emotionally-framed explanation ("stressed or down"; one positively- and one negatively framed), one mixed emotion and cognition ("mind and body work together"), and two physically based explanations ("over-excited state", "overstimulated")
Subjects completed the following questionnaires: (1) a demographic survey including the following variables: age, sex, race/ethnicity, marital status, work status, insurance status, level of education, number of i) people living in the household, ii) children living in the household, iii) adults living in the household, iv) adults who generate income; (2) the Generalized Anxiety Disorder 2-item version (GAD-2); (3) the Patient Health Questionnaire 2-item version (PHQ-2); (4) the Pain Self-Efficacy Questionnaire 2-item version (PSEQ-2); and (5) the Pain Catastrophizing Scale 4-item version (PCS-4).
Patients rated resonance with the explanation of more pain than expected on a 5-point Likert scale as follows from 1 to 5: "nope I don't buy it", "this doesn't make sense", "I'm not sure how I feel about this", "this makes sense", and "absolutely, that makes perfect sense".
Self-Assessment Manikins (SAM; a picture-oriented instrument) were used to measure 3 affective dimensions, happiness, excitement and control in response to the explanation.
The happiness dimension ranges from a smiling happy to a frowning unhappy SAM figure. The excitement dimension ranges from an excited wide-eyed to a relaxed sleepy SAM figure. The control dimension is represented with a changing size of the SAM figure and ranges from a small to a large SAM figure; the largest represents the most control in the situation.
The GAD-2 is a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of anxiety in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of anxiety.
The PCS-4 measures less adaptive thoughts in response to nociception on a 4-item scale (0=not at all to 4=all the time). The scale contains two items on magnification, one item on rumination, and one item on helplessness. Total score ranges from 0 to 16, higher scores indicate more catastrophic thoughts.
The PSEQ-2 measures two beliefs: that one can engage in activities and enjoy life in spite of pain. The total score ranges from 0 (not at all confident) to 12 (completely confident).
The PHQ-2 is a 2-item questionnaire that measures symptoms of depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the mind is a great story teller-positively framed | Active Comparator | explanations for more pain than expected |
|
| the mind is a great story teller-negatively framed | Active Comparator | explanations for more pain than expected |
|
| emotionally-framed explanation-stressed or down-positive frame | Active Comparator | explanations for more pain than expected |
|
| emotionally-framed explanation-stressed or down-negative frame | Active Comparator | explanations for more pain than expected |
|
| mixed emotion and cognition ("mind and body work together") | Active Comparator | explanations for more pain than expected |
|
| physically based explanations "over-excited state" | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Explanation | Other | Explanation provided to patients for more pain than expected |
|
| Measure | Description | Time Frame |
|---|---|---|
| resonance with the explanation of more pain than expected | Patients rated resonance with the explanation of more pain than expected on a 5-point Likert scale from 1 to 5, as follows: "nope, I don't buy it," "this doesn't make sense," "I'm not sure how I feel about this," "this makes sense," and "absolutely, that makes perfect sense." Likert scales are valid for measuring variation in opinion. This specific Likert scale is new and specific to this study, and so no minimum clinically important difference has been defined. Given how the scale is anchored, a difference of about 1 point seems relevant. | up to 24 weeks |
| Self-Assessment Manikins(SAM) | Self-assessment manikins (SAMs), a picture-oriented instrument, were used to measure three affective dimensions of happiness, stimulation/excitement, and security/control in response to the explanations. The happiness dimension ranges from a smiling, happy SAM figure to a frowning, unhappy figure. The excitement dimension ranges from an excited, wide-eyed SAM figure to a relaxed, sleepy figure. The control dimension is represented by an SAM figure that changes in size and ranges from a small SAM figure to a large one; the largest figure represents the greatest feeling of security and control. With respect to written explanations of the mind-body connection, we favored greater feelings of happiness and control and relatively neutral feelings of excitement. | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| demographic survey | age, sex, race/ethnicity, marital status, work status, insurance status, level of education, number of i) people living in the household, ii) children living in the household, iii) adults living in the household, iv) adults who generate income | up to 24 weeks |
| GAD-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ring, MD, PhD | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dell Medical School, University of Texas at Austin | Austin | Texas | 78701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33411452 | Derived | Gonzalez AI, Kortlever JTP, Brown LE, Ring D, Queralt M. Can Crafted Communication Strategies Allow Musculoskeletal Specialists to Address Health Within the Biopsychosocial Paradigm? Clin Orthop Relat Res. 2021 Jun 1;479(6):1217-1223. doi: 10.1097/CORR.0000000000001635. |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7 brief explanations of the mind-body connection with variations in cognitive, emotional, or physiology-based explanations.
Not provided
Not provided
Not provided
explanations for more pain than expected
|
| physically based explanations "overstimulated" | Active Comparator | explanations for more pain than expected |
|
a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of anxiety in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of anxiety |
| up to 24 weeks |
| PCS-4 | measures less adaptive thoughts in response to nociception on a 4-item scale (0=not at all to 4=all the time). The scale contains two items on magnification, one item on rumination, and one item on helplessness. Total score ranges from 0 to 16, higher scores indicate more catastrophic thoughts | up to 24 weeks |
| PSEQ-2 | measures two beliefs: that one can engage in activities and enjoy life in spite of pain. The total score ranges from 0 (not at all confident) to 12 (completely confident). | up to 24 weeks |
| PHQ-2 | a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of depression in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of depression | up to 24 weeks |