NCT01645566

Brief Summary

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

  1. 1.describe the stress patterns experienced during a CPR situation;
  2. 2.investigate whether the perceived stress was associated with CPR performance in terms of hands-on time and time to start CPR;
  3. 3.to investigate whether this task focusing strategy reduces perceived stress levels, and
  4. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

July 15, 2012

Last Update Submit

July 19, 2012

Conditions

Keywords

cardiopulmonary resuscitationstressintervention

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • hands-on time

    time from start of CPR until scenario is finished (usually 5-10min)

  • time to start CPR

    time from start of CPR until scenario is finished (usually 5-10min)

  • Number of leadership statements

    time from start of CPR until scenario is finished (usually 5-10min)

Study Arms (2)

intervention

EXPERIMENTAL

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)

Behavioral: instruction

Control

NO INTERVENTION

No instructions

Interventions

instructionBEHAVIORAL

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)

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • th year medical students

You may not qualify if:

  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 22115935BACKGROUND
  • 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.

    PMID: 21695475BACKGROUND
  • 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.

    PMID: 21658557BACKGROUND
  • Hunziker S, Pagani S, Fasler K, Tschan F, Semmer NK, Marsch S. Impact of a stress coping strategy on perceived stress levels and performance during a simulated cardiopulmonary resuscitation: a randomized controlled trial. BMC Emerg Med. 2013 Apr 22;13:8. doi: 10.1186/1471-227X-13-8.

MeSH Terms

Conditions

Stress, Psychological

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Sabina Hunziker, MD, MPH

    University Hospital Basel, Medical Intensive Care Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 15, 2012

First Posted

July 20, 2012

Study Start

December 1, 2007

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

July 20, 2012

Record last verified: 2012-07

Locations