Breaking Bad News - Optimizing Stress Response and Communication Performance in Medical Students

NCT05037318 | Completed DMC

• 2 other identifiers: BBN BPSM100019_200831
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

Breaking bad news (e.g., telling patients that they have cancer) is not only very stressful for the patients concerned, but also for the physicians delivering the diagnosis. It is unclear how this burden and the associated communication performance can be optimized. The project contributes to this goal. The main goal of the project is to scientifically analyze to what extent the stress reaction and communication performance of medical students can be optimized when breaking bad news. Two strategies will be employed and tested for their effectiveness: First, "stress arousal reappraisal", which consists in reinterpreting physiological arousal (e.g., increased heart rate) as adaptive and beneficial for task performance. Second, medical students can be well prepared for breaking bad news by learning from worked examples (step-by-step demonstrations of how to break bad news). The investigators hypothesize that both strategies will shift the interpretation of breaking bad news from a threat to a challenge state. This will lead to better communication performance during the task. To test the hypothesis, about 200 medical students' communication performance, cardiovascular activity, stress hormone release, and subjective stress perception when communicating a serious cancer diagnosis to a simulated patient (actor) will be measured. The results of the study provide a first comprehensive picture of the psychophysiological stress patterns of medical students who are entrusted with a stressful communication task. Ultimately, this may promote stress management and communication skills in future physicians.

Conditions

Stress Reaction

Keywords

Breaking bad news; Stress; Stress arousal reappraisal; Stressful communication; Communication skills; Worked example; Biopsychosocial model

Outcome Measures

Primary Outcomes (1)

• Breaking bad news performance

  SPIKES (6 items) and global Bad News Assessment Scale (glBAS; 5 items); both five-point ratings ranging from 1 to 5, glBAS is scored in reverse to match SPIKES scale, the higher the score, the better the performance

  After 2 hours. Duration: 12 minutes

Secondary Outcomes (7)

• Change in self-reported mood

  During 3 hours, multiple pre and post intervention measures

• Change in heart rate

  During 3 hours, multiple pre and post intervention measures

• Change in pre-ejection period

  During 3 hours, multiple pre and post intervention measures

• Change in challenge-threat cardiovascular index

  During 3 hours, multiple pre and post intervention measures

• Change in anabolic balance

  During 3 hours, multiple pre and post intervention measures

Study Arms (4)

Stress arousal reappraisal

EXPERIMENTAL

Behavioral: Stress arousal reappraisal

Worked examples

EXPERIMENTAL

Behavioral: Worked examples

Stress arousal reappraisal + Worked examples

EXPERIMENTAL

Behavioral: Stress arousal reappraisal; Behavioral: Worked examples

Control

NO INTERVENTION

Interventions

Stress arousal reappraisal BEHAVIORAL

Participants will watch a video explaining that stress arousal is not harmful but rather functional and adaptive for performance in stressful situations.

Stress arousal reappraisal; Stress arousal reappraisal + Worked examples

Worked examples BEHAVIORAL

The worked example will be in form of brief video sequences showing a physician (played by an actor) delivering the bad diagnosis of lung cancer to an SP following the SPIKES protocol.

Stress arousal reappraisal + Worked examples; Worked examples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being currently enrolled as a third-year medical student
• Being German speaker
• Signed consent form

You may not qualify if:

• Cardiovascular diseases known to affect the variables under investigation
• Neuroendocrine conditions known to affect the variables under investigation
• Use of psychotropic drugs or any medication known to affect the variables under investigation (e.g., corticosteroids, cardioactive medication)
• Wearing a pacemaker
• Pregnancy/Breastfeeding

Sponsors & Collaborators

• University of Bern: lead
• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: collaborator
• University of Vienna: collaborator

Study Sites (1)

Institute for Medical Education

Bern, 3012, Switzerland

Location

Related Publications (1)

• Bosshard M, Schmitz FM, Guttormsen S, Nater UM, Gomez P, Berendonk C. From threat to challenge-Improving medical students' stress response and communication skills performance through the combination of stress arousal reappraisal and preparatory worked example-based learning when breaking bad news to simulated patients: study protocol for a randomized controlled trial. BMC Psychol. 2023 May 10;11(1):153. doi: 10.1186/s40359-023-01167-6.

  PMID: 37165406 DERIVED

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Christoph Berendonk, PD Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants know the content of their intervention, however, they do not know what other interventions there are and which group they belong to.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two interventions are used, participants either receive only a stress reappraisal, only worked examples on breaking bad news, both interventions together, or none of the interventions.

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: April 21, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available as soon as the study is published.
• Access Criteria: The investigators will make supplementary files and key datasets accompanying a publication to demonstrate reproducibility openly available in appropriate digital data repositories that conform to the Fair Data principles and maintained by a non-profit organisation. Specific datasets will be shared via domain-specific public repositories. Unstructured data will be shared via data repository Zenodo or Dryad. These data repositories fulfill biomedical journals' and SNSF's requirements (allowing publishing FAIR data, non-commercial).

Locations

CH (1)