Mental StressNCT01645566
Task Focusing Strategy During a Simulated Cardiopulmonary Resuscitation
A study testing instruction in people with Mental Stress, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Stress
- What is being tested?
- instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2007to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 4th year medical students
Who cannot join
- No informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Impact of a Task Focusing Strategy on Perceived Stress Levels and Performance During a Simulated Cardiopulmonary Resuscitation: A Randomized Controlled Trial
This is a prospective randomized controlled study. The aim of this study is to
- describe the stress patterns experienced during a CPR situation;
- investigate whether the perceived stress was associated with CPR performance in terms of hands-on time and time to start CPR;
- to investigate whether this task focusing strategy reduces perceived stress levels, and
- 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.
- Conditions
- Mental Stress
- Being tested
- instruction
- Keywords
- cardiopulmonary resuscitation, stress, intervention
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instructionBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: instruction |
| Control | No intervention | No instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: time from start of CPR until scenario is finished (usually 5-10min)
Secondary outcomes (3)
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
Measured: time from start of CPR until scenario is finished (usually 5-10min)
time to start CPR
Measured: time from start of CPR until scenario is finished (usually 5-10min)
Number of leadership statements
Measured: time from start of CPR until scenario is finished (usually 5-10min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startDec 2007
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental StressStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Schuetz, University Hospital, Basel, Switzerland
- Investigators
- Sabina Hunziker, MD, MPH, Principal investigator, University Hospital Basel, Medical Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645566
- Sponsor's protocol ID
- BS1330978
- Status last verified
- Jul 2012
- First submitted
- 15 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22115935Hunziker 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.
PubMed 21695475Hunziker 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.
PubMed 21658557Hunziker 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.
PubMed 23607331
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Task Focusing Strategy on Perceived Stress Levels and Performance During a Simulated Cardiopulmonary Resuscitation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01645566
- Acronym / sponsor ID
- BS1330978
- Conditions
- Mental Stress
- Keywords
- cardiopulmonary resuscitation, stress, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized controlled study. The aim of this study is to
- describe the stress patterns experienced during a CPR situation;
- investigate whether the perceived stress was associated with CPR performance in terms of hands-on time and time to start CPR;
- to investigate whether this task focusing strategy reduces perceived stress levels, and
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: instructioninstructions 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) |
| Control | No intervention | –No instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 4th year medical students
Key exclusion criteria (1 listed)
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| instructioninstructions 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) | Behavioural | intervention |
Primary outcome
perceived levels of stress and feeling overwhelmed (stress/overload)
Time frame: time from start of CPR until scenario is finished (usually 5-10min)
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
3 secondary outcomes
hands-on time
Time frame: time from start of CPR until scenario is finished (usually 5-10min)
time to start CPR
Time frame: time from start of CPR until scenario is finished (usually 5-10min)
Number of leadership statements
Time frame: time from start of CPR until scenario is finished (usually 5-10min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
- Background: PubMed 22115935Hunziker 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.
- Background: PubMed 21695475Hunziker 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.
- Background: PubMed 21658557Hunziker 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.
- Derived from this study: PubMed 23607331Hunziker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabina Hunziker, MD, MPH principal investigator
University Hospital Basel, Medical Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing instruction in people with Mental Stress, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perceived levels of stress and feeling overwhelmed (stress/overload) (time frame: time from start of CPR until scenario is finished (usually 5-10min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01645566, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2012.