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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01826318
Other study ID # SH_SIP_2007
Secondary ID
Status Completed
Phase N/A
First received April 3, 2013
Last updated April 3, 2013
Start date December 2007
Est. completion date May 2008

Study information

Verified date April 2013
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

This study assessed the impact of a task-focusing strategy on perceived stress levels and performance during a simulated CPR scenario.


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.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date May 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- 4th year medical students

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Behavioral:
Stress coping
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.

Locations

Country Name City State
Switzerland University Hospital Basel, ICU Basel BS

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average level of stress/overload during the resuscitation period 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 No
Secondary hands-on time 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. No
Secondary time elapsed until CPR was started 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 No
Secondary leadership statements 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 No
See also
  Status Clinical Trial Phase
Completed NCT00884559 - Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation N/A