Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01304030
Other study ID # 2009P001599
Secondary ID P001599
Status Completed
Phase N/A
First received February 19, 2011
Last updated February 23, 2011
Start date February 2010
Est. completion date December 2010

Study information

Verified date February 2011
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority USA: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Our research hypothesis is that residents who participate in the empathy and relational skills training modules will significantly improve in these skills as compared to a control group of residents who receive residency training as usual that includes the current standard training in the doctor-patient relationship. To evaluate this hypothesis, we will use a two-pronged approach to assessment. The first prong is the residents' self assessment of empathy and the second is from the patients' perspective.


Description:

The study design is a randomized controlled trial assigning resident physicians (N=100) to either: (a) empathy and relational skills training; or (b) control group receiving standard residency training as usual. Over the course of six weeks, each resident physician in the experimental group will receive three 60-minute training sessions focused on empathy and relational skills (the residents assigned to the control condition will receive standard residency training as usual). The emerging neuroscience of emotions and empathy has provided the neurobiological and physiological bases for our Empathy Training Modules to enhance patient-doctor communication. These innovative modules provide the basic science and video modeling for empathy training. Based on cutting edge mirror neuron research, our training modules offer a novel approach to empathy and relational skills training that teaches physicians about the neurobiology and physiology of emotions in difficult or stressful patient interactions. We have developed professionally produced high definition training modules that portray difficult patient-physician interactions. Importantly, these videos also include physiological displays of emotion for both members of the dyad so that one can easily observe the degree to which patient and physician are physiologically concordant or discordant with one another. The empathy training is conducted at a deeper level of physiological awareness and regulation that promises to be more effective than traditional didactic teaching by integrating the technology of psychophysiology. The goal of raising awareness of physiologic indices during a patient-doctor interaction is to present an objective measure of emotional response to both explicit and implicit stimuli, which promises to be a powerful teaching tool to enhance empathic physician behaviors.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

All medical and surgical residents who are based at Massachusetts General Hospital will be eligible to participate in the study.

Exclusion Criteria:

Residents who are rotating at sites other then Massachusetts General Hospital Residents who are on rotations that do not include clinical care

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Empathy Training Modules
The Empathy Training Modules utilize translational research in emotion expression basic science, physiology of emotions, decoding facial expressions and self-regulation skills as pertaining to management of medical and surgical patients.
Residency Training as usual
Residents will receive their typical didactic and clinical education

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

Riess H, Kelley JM, Bailey R, Konowitz PM, Gray ST. Improving empathy and relational skills in otolaryngology residents: a pilot study. Otolaryngol Head Neck Surg. 2011 Jan;144(1):120-2. doi: 10.1177/0194599810390897. — View Citation

Riess H. Empathy in medicine--a neurobiological perspective. JAMA. 2010 Oct 13;304(14):1604-5. doi: 10.1001/jama.2010.1455. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Consultation and Relational Empathy Measure (CARE) measure At baseline: (1) Residents will complete the CARE measure (2) 10 patients in each resident's clinic will rate their encounter using the CARE Measure; (3) Residents will receive the Empathy and Relational Training Modules or residency training as usual. At the six-week endpoint: (4) residents will complete the CARE measure and (5) patients will complete the CARE measure after the clinic visit. Up to 5 weeks (this is an average) Yes
Secondary Jefferson Empathy Scale Mehrabian Balanced Emotional Empathy Scale (BEES) (30 items) 2.Jefferson Empathy Scale (20 items 3. Neuroscience of Emotions Assessment 4. Ekman Facial Expression Decoding Assessment The Mehrabian BEES Measures baseline empathy. The Jefferson Scale measures physician attitudes about the importance of empathy in clinical medical care. The Neuroscience of Emotions Test measures knowledge of basic science of emotions. The Ekman test measures ability to decode subtle facial expressions. Prospective No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05447611 - Role of Empathy in Curative Treatment Outcomes of Non-metastatic Colorectal Cancer.
Completed NCT02681380 - Impact of a Relation Training on Empathy of Medical Student N/A
Completed NCT03488927 - Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking N/A
Completed NCT05117944 - Drama-supported Patient Role Experience of Nursing Students N/A
Completed NCT04392869 - The Effects of Mindfulness-based Training in Undergraduate Students of Translation and Interpreting N/A
Completed NCT02377284 - Prevention and Management of Food Allergies N/A
Completed NCT05598944 - The Effects of Psycho-educational Training in Undergraduate Students at the University of Granada (Spain) N/A
Completed NCT05581381 - Empathy Training Program for Nursing Staff N/A
Not yet recruiting NCT06064513 - Video-Based Empathy Training for Nurses N/A
Recruiting NCT04424420 - Mental Effects of Analgesic Drugs: Paracetamol and Ibuprofen Phase 1
Recruiting NCT04625582 - Educational Intervention for the Development of Professionals Skills in Family Medicine and Community Nursing Residents N/A
Recruiting NCT05088694 - The Optimization and Evaluation of the Extremism and Intolerance Curriculum for the Kingdom of Bahrain. N/A
Completed NCT03330665 - Meditation and Student Empathy N/A
Completed NCT04889508 - Investigating Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion N/A
Not yet recruiting NCT06352034 - Empathy Training for Psychology Students Trainees N/A
Completed NCT03200873 - Effects of rTMS on Impulsivity and Empathy N/A
Completed NCT03216629 - Sorry Not Sorry: Apologizing and Its Effect on Discomfort During Dressing Removal N/A
Active, not recruiting NCT04921423 - The Study on the Attitude and Empathy of Nursing Students Towards the Elderly N/A
Not yet recruiting NCT06136676 - From the Heart: Comparing the Effects of Spiritual and Secular Meditation on Psychophysiology, Cognition, Mental Health, and Social Functioning in Healthy Adults N/A
Completed NCT06410560 - Culture is Care: Training Workshop for Care Workers (VerbaCurant) N/A