- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01826318
Stress Coping Strategy on Perceived Stress Levels and Performance During a Simulated Cardiopulmonary Resuscitation
Impact of a Stress Coping Strategy on Perceived Stress Levels and Performance During a Simulated Cardiopulmonary Resuscitation: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Cardiopulmonary resuscitation (CPR) causes significant stress, which may cause deficiencies in attention and increase distractibility. This may lead to misjudgements of priorities and delays in CPR performance, which may further increase mental stress (vicious cycle).
Aim: This study assessed the impact of a task-focusing strategy on perceived stress levels and performance during a simulated CPR scenario.
Methods: This is a prospective, randomized-controlled trial
Setting: Simulator-center of the University Hospital Basel, Switzerland.
Participants: A total of 124 volunteer medical students
Intervention: Randomization to receive a 10 minute instruction to cope with stress by loudly posing two task-focusing questions ("what is the patient's condition?", "what immediate action is needed?") when feeling overwhelmed by stress (intervention group) or a control group.
Outcome measures: The primary outcome is the perceived levels of stress and feeling overwhelmed (stress/overload); secondary outcomes were hands-on time, time to start CPR and number of leadership statements.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
BS
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Basel, BS, Switzerland, 4055
- University Hospital Basel, ICU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 4th year medical students
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention
Participants received a 10 minute instruction to cope with stress by loudly posing two task-focusing questions ("what is the patient's condition?",
"what immediate action is needed?")
when feeling overwhelmed by stress (intervention group)
|
Students in the intervention group received a 10 minute instruction to cope with stress.
They were informed that an emergency situation is a stressful experience for health care workers and that perceived stress may interfere with their decision-making abilities and performance.
Particularly, feeling overwhelmed by stress may cause cognitive impairment potentially leading to loss of concept how to deal with an emergency situation, which in turn further increases stress (vicious cycle).
However, it is possible to overcome this situation by focusing on the basic conditions of the situation and the immediate actions that are needed.
They were instructed that they should ask two task-focusing questions aloud ("what is the patient's condition?",
"what immediate action is needed?") to overcome the negative consequences of feeling overwhelmed by stress.
|
|
No Intervention: Control
Students in the control group did not receive any further instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average level of stress/overload during the resuscitation period
Time Frame: In the first 120 seconds after the onset of the cardiac arrest
|
The primary outcome was the average level of stress/overload during the resuscitation period for the experimental and the control group.
|
In the first 120 seconds after the onset of the cardiac arrest
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hands-on time
Time Frame: in the first 120 seconds after the onset of the cardiac arrest.
|
Medical performance measures: hands-on time defined as duration of uninterrupted chest compressions and defibrillation in the first 120 seconds after the onset of the cardiac arrest.
|
in the first 120 seconds after the onset of the cardiac arrest.
|
|
time elapsed until CPR was started
Time Frame: in the first 120 seconds after the onset of the cardiac arrest
|
the time elapsed until CPR was started, defined as the time to the first meaningful measure (either defibrillation, chest compression or ventilation) after the onset of the cardiac arrest; the team coordination measure
|
in the first 120 seconds after the onset of the cardiac arrest
|
|
leadership statements
Time Frame: in the first 120 seconds after the onset of the cardiac arrest
|
Number of leadership statements coded, using a predefined checklist containing the following categories based on previous research
|
in the first 120 seconds after the onset of the cardiac arrest
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sabina Hunziker, MD, MPH, University Hospital Basel, Basel 4031 Basel, Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SH_SIP_2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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