Can Crafted Communication Strategies Allow Musculoskeletal Specialists to Address Health Within the Biopsychosocial Paradigm?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 2
- 主要终点
- resonance with the explanation of more pain than expected
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all new or return orthopaedic patients aged 18 to 89 years old
排除标准
- •Illiteracy
- •Cognitive problems which patient was not able to fill surveys
结局指标
主要结局
resonance with the explanation of more pain than expected
时间窗: up to 24 weeks
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.
Self-Assessment Manikins(SAM)
时间窗: up to 24 weeks
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.
resonance with the explanation of more pain than expected
时间窗: up to 24 weeks
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.
Self-Assessment Manikins(SAM)
时间窗: up to 24 weeks
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.
次要结局
- demographic survey(up to 24 weeks)
- GAD-2(up to 24 weeks)
- PCS-4(up to 24 weeks)
- PSEQ-2(up to 24 weeks)
- PHQ-2(up to 24 weeks)
- demographic survey(up to 24 weeks)
- GAD-2(up to 24 weeks)
- PCS-4(up to 24 weeks)
- PSEQ-2(up to 24 weeks)
- PHQ-2(up to 24 weeks)
研究者
David Ring
Professor of surgery and perioperative care
University of Texas at Austin