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Trials / Completed

CompletedNCT04482348

Crafted Communication for Biopsychosocial Care in Musculoskeletal Practice

Can Crafted Communication Strategies Allow Musculoskeletal Specialists to Address Health Within the Biopsychosocial Paradigm?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
308 (actual)
Sponsor
University of Texas at Austin · Academic / Other
Sex
All
Age
18 Years – 89 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERExplanationExplanation provided to patients for more pain than expected

Timeline

Start date
2019-08-01
Primary completion
2019-12-01
Completion
2020-01-30
First posted
2020-07-22
Last updated
2025-07-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04482348. Inclusion in this directory is not an endorsement.