Crafted Communication for Biopsychosocial Care in Musculoskeletal Practice

NCT04482348 | Completed

• 1 other identifier: 2019-01-0084
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health Wellness 1

Keywords

cognitive health; social health; emotional health

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

Study Arms (7)

the mind is a great story teller-positively framed

ACTIVE COMPARATOR

explanations for more pain than expected

Other: Explanation

the mind is a great story teller-negatively framed

ACTIVE COMPARATOR

explanations for more pain than expected

Other: Explanation

emotionally-framed explanation-stressed or down-positive frame

ACTIVE COMPARATOR

explanations for more pain than expected

Other: Explanation

emotionally-framed explanation-stressed or down-negative frame

ACTIVE COMPARATOR

explanations for more pain than expected

Other: Explanation

mixed emotion and cognition ("mind and body work together")

ACTIVE COMPARATOR

explanations for more pain than expected

Other: Explanation

physically based explanations "over-excited state"

ACTIVE COMPARATOR

explanations for more pain than expected

Other: Explanation

physically based explanations "overstimulated"

ACTIVE COMPARATOR

explanations for more pain than expected

Other: Explanation

Interventions

Explanation OTHER

Explanation provided to patients for more pain than expected

emotionally-framed explanation-stressed or down-negative frame; emotionally-framed explanation-stressed or down-positive frame; mixed emotion and cognition ("mind and body work together"); physically based explanations "over-excited state"; physically based explanations "overstimulated"; the mind is a great story teller-negatively framed; the mind is a great story teller-positively framed

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all new or return orthopaedic patients aged 18 to 89 years old

You may not qualify if:

• Illiteracy
• Cognitive problems which patient was not able to fill surveys

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Medical School, University of Texas at Austin

Austin, Texas, 78701, United States

Location

Related Publications (1)

• 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.

  PMID: 33411452 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• David Ring, MD, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of surgery and perioperative care

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 22, 2020
• Study Start: August 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 30, 2020
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)