Reaction to Mind-Body Connection
Condition: Mental Health Wellness 1
Study type: Interventional

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.
    

Intervention name(s): Explanation
Intervention type(s): Other
Intervention description(s): Explanation provided to patients for more pain than expected
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: cognitive health; social health; emotional health