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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01645566
Other study ID # BS1330978
Secondary ID
Status Completed
Phase N/A
First received July 15, 2012
Last updated July 19, 2012
Start date December 2007
Est. completion date July 2008

Study information

Verified date July 2012
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: EKBB
Study type Interventional

Clinical Trial Summary

This is a prospective randomized controlled study. The aim of this study is to

1. describe the stress patterns experienced during a CPR situation;

2. investigate whether the perceived stress was associated with CPR performance in terms of hands-on time and time to start CPR;

3. to investigate whether this task focusing strategy reduces perceived stress levels, and

4. whether this translates into better CPR performance. Based on findings that clear, directive leadership can enhance performance in cardiac resuscitation, we further 5) investigate if stress was associated with fewer leadership statements.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date July 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 4th year medical students

Exclusion Criteria:

- No informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)


Related Conditions & MeSH terms


Intervention

Behavioral:
instruction
instructions about focusing on relevant task elements by posing two task-focusing questions ("what is the patient's condition?", "what immediate action is needed?") when feeling overwhelmed by stress (intervention-group)

Locations

Country Name City State
Switzerland University Hospital Basel Basel BS

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Hunziker S, Johansson AC, Tschan F, Semmer NK, Rock L, Howell MD, Marsch S. Teamwork and leadership in cardiopulmonary resuscitation. J Am Coll Cardiol. 2011 Jun 14;57(24):2381-8. doi: 10.1016/j.jacc.2011.03.017. Review. — View Citation

Hunziker S, Laschinger L, Portmann-Schwarz S, Semmer NK, Tschan F, Marsch S. Perceived stress and team performance during a simulated resuscitation. Intensive Care Med. 2011 Sep;37(9):1473-9. doi: 10.1007/s00134-011-2277-2. Epub 2011 Jun 22. — View Citation

Hunziker S, Semmer NK, Tschan F, Schuetz P, Mueller B, Marsch S. Dynamics and association of different acute stress markers with performance during a simulated resuscitation. Resuscitation. 2012 May;83(5):572-8. doi: 10.1016/j.resuscitation.2011.11.013. Epub 2011 Nov 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary perceived levels of stress and feeling overwhelmed (stress/overload) This is a simulator study and the study starts after students entered the simulator and the manikin has a cardiac arrest. The scenarios usually last for not more than 5-10 min at which time point the study is finished time from start of CPR until scenario is finished (usually 5-10min) No
Secondary hands-on time This is a simulator study and the study starts after students entered the simulator and the manikin has a cardiac arrest. The scenarios usually last for not more than 5-10 min at which time point the study is finished time from start of CPR until scenario is finished (usually 5-10min) No
Secondary time to start CPR time from start of CPR until scenario is finished (usually 5-10min) No
Secondary Number of leadership statements time from start of CPR until scenario is finished (usually 5-10min) No
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