Asphyxia NeonatorumNCT03606278
Evaluation of Two Strategies for Debriefing in the Development of Skills for Neonatal Resuscitation
A study testing Structured debriefing assisted by video and Structured oral debriefing in people with Asphyxia Neonatorum and Birth Injuries, run by Universidad de la Sabana.
Trial summary
Introduction: Training of health professionals in neonatal resuscitation reduces risks and adverse events during this intervention. Simulation-based education with constructive immediate feedback (debriefing) is an effective teaching method for personnel in charge of neonatal resuscitation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asphyxia Neonatorum, Birth Injuries, Cardiopulmonary Resuscitation
- What is being tested?
- Structured debriefing assisted by video and Structured oral debriefing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 15 Jun 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The specialized health professionals (Professional nurses, respiratory therapists, and pediatricians) in charge of newborn care that working in the Neonatal Unit areas, maternity wards, surgery rooms responsible for the care of caesarean sections, and those of pediatric emergencies of University Hospital of La Sabana
Who cannot join
- None
About this study
Official title: Evaluation of Two Strategies for Constructive Immediate Feedback in the Development of Skills for Neonatal Resuscitation: a Randomized Clinical Trial
Introduction: Training of health professionals in neonatal resuscitation reduces risks and adverse events during this intervention. Simulation-based education with constructive immediate feedback (debriefing) is an effective teaching method for personnel in charge of neonatal resuscitation.
Objective: To evaluate two debriefing strategies for the development of neonatal resuscitation skills in professionals specialized in critical newborn care.
Read more
Materials and Methods: A simple blind randomized clinical trial was conducted. Twenty-four professionals (pediatricians, nurses, and respiratory therapists) were randomly assigned for two interventions; one group received oral debriefing and the other oral debriefing assisted by video. Three standardized clinical scenarios that were recorded on video were executed. A checklist was applied for the evaluation, administered by a reviewer blinded to the assignment of the type of debriefing.
Null hypothesis: The improved in the skills of neonatal resuscitation is the same for both strategies of debriefing.
Alternative hypothesis: The improved in the skills of neonatal resuscitation is different for both strategies of debriefing
- Being tested
- Structured debriefing assisted by video, Structured oral debriefing
- Keywords
- Debriefing
- Medical subject headings
- Asphyxia Neonatorum, Birth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured debriefing assisted by videoOther
In the structured debriefing assisted by video, the process was based on the immediate review of the video, stopping and rewinding the recording as required. The debriefing session was conducted in the debriefing room of the simulation laboratory with an assigned time of 15 minutes. Each session was developed in three phases. The first phase, descriptive, in which each participant was encouraged to recount what they had lived and experienced, clarifying how the events unfolded, verifying the appropriate decisions and the errors committed in the scenario and the ways they could have solved them and corrected them. The second phase, analytical, the participant reflected on what occurred in the scenario, commenting on how their feelings were involved in the development of the case. The third phase, application or transference, in which the group was encouraged to draw conclusions from what had occurred, realizing an application of this experience in a real-life.
Structured oral debriefingOther
In the structured oral debriefing, the process was based by the mental search of their memories of what occurred. The debriefing session was conducted in the debriefing room of the simulation laboratory with an assigned time of 15 minutes. Each session was developed in three phases. The first phase, descriptive, in which each participant was encouraged to recount what they had lived and experienced, clarifying how the events unfolded, verifying the appropriate decisions and the errors committed in the scenario and the ways they could have solved them and corrected them. The second phase, analytical, the participant reflected on what occurred in the scenario, commenting on how their feelings were involved in the development of the case. The third phase, application or transference, in which the group was encouraged to draw conclusions from what had occurred, realizing an application of this experience in a real-life.
| Study group | Role | What they receive |
|---|---|---|
| Structured debriefing assisted by video | Experimental | In the structured debriefing assisted by video, the process was based on the immediate review of the video, stopping and rewinding the recording as required. Receives: Other: Structured debriefing assisted by video |
| Structured oral debriefing | Active comparator | In the structured oral debriefing, the process was based by the mental search of their memories of what occurred. Receives: Other: Structured oral debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance percentage of the activities
For the performance and evaluation score of the adherence of the teams to the resuscitation protocols, a review of the literature was performed for constructed a checklist that included cognitive/technical and behavioral aspects of individual performance and performance by profession in each of the scenarios. Each item of the tool was assigned a score of 1 if the evaluated activity was correctly performed, 0 if it was not performed correctly, and N/A if it did not apply for the scenario and/or for the profession. A compliance percentage (range 0% to 100%) of the activities evaluated by participant in the tool was obtained, summed the points obtained onto the possible total score. The higher percentage indicate better outcome.
Measured: The checklist was applied by a reviewer blinded to the assignment of the type of debriefing by reviewing the video, on average 1 week after of the participation of the groups in the scenarios.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Feb 2016
- Primary completion15 Jun 2016
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asphyxia NeonatorumStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study participants were randomly assigned to the type of debriefing (oral or video), stratified by the type of health professional. For this randomization, the random function of Excel was used, sorting the participants in a random number order and assigning the first half to the oral group and the other half to the video-assisted group. For the conformation of the teams, a second randomization was performed, in which the professionals within an assigned group (oral or video-assisted) were randomized to form a resuscitation team. In this randomization, Excel's random function was also used, sorting the patients in a random number order and assigning the one that was ordered first to team 1, the second to team 2, and so on, each team had three professions: pediatrician, professional nurse, and respiratory therapist. The same team was maintained during the participation of each scenario.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606278
- Sponsor's protocol ID
- Acta 366 11-Dic-2015
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Sawyer T, Sierocka-Castaneda A, Chan D, Berg B, Lustik M, Thompson M. Deliberate practice using simulation improves neonatal resuscitation performance. Simul Healthc. 2011 Dec;6(6):327-36. doi: 10.1097/SIH.0b013e31822b1307.
PubMed 21937960Gamboa OA, Agudelo SI, Maldonado MJ, Leguizamon DC, Cala SM. Evaluation of two strategies for debriefing simulation in the development of skills for neonatal resuscitation: a randomized clinical trial. BMC Res Notes. 2018 Oct 17;11(1):739. doi: 10.1186/s13104-018-3831-6.
PubMed 30333050
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Strategies for Constructive Immediate Feedback in the Development of Skills for Neonatal Resuscitation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03606278
- Acronym / sponsor ID
- Acta 366 11-Dic-2015
- Keywords
- Debriefing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 15 Jun 2016 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 30 Jul 2018 (actual)
- 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.
Introduction: Training of health professionals in neonatal resuscitation reduces risks and adverse events during this intervention. Simulation-based education with constructive immediate feedback (debriefing) is an effective teaching method for personnel in charge of neonatal resuscitation.
Objective: To evaluate two debriefing strategies for the development of neonatal resuscitation skills in professionals specialized in critical newborn care.
Materials and Methods: A simple blind randomized clinical trial was conducted. Twenty-four professionals (pediatricians, nurses, and respiratory therapists) were randomly assigned for two interventions; one group received oral debriefing and the other oral debriefing assisted by video. Three standardized clinical scenarios that were recorded on video were executed. A checklist was applied for the evaluation, administered by a reviewer blinded to the assignment of the type of debriefing.
Null hypothesis: The improved in the skills of neonatal resuscitation is the same for both strategies of debriefing.
Alternative hypothesis: The improved in the skills of neonatal resuscitation is different for both strategies of debriefing
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study participants were randomly assigned to the type of debriefing (oral or video), stratified by the type of health professional. For this randomization, the random function of Excel was used, sorting the participants in a random number order and assigning the first half to the oral group and the other half to the video-assisted group. For the conformation of the teams, a second randomization was performed, in which the professionals within an assigned group (oral or video-assisted) were randomized to form a resuscitation team. In this randomization, Excel's random function was also used, sorting the patients in a random number order and assigning the one that was ordered first to team 1, the second to team 2, and so on, each team had three professions: pediatrician, professional nurse, and respiratory therapist. The same team was maintained during the participation of each scenario.
| Arm | Type | Receives |
|---|---|---|
| Structured debriefing assisted by video | Experimental | Other: Structured debriefing assisted by videoIn the structured debriefing assisted by video, the process was based on the immediate review of the video, stopping and rewinding the recording as required. |
| Structured oral debriefing | Active comparator | Other: Structured oral debriefingIn the structured oral debriefing, the process was based by the mental search of their memories of what occurred. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The specialized health professionals (Professional nurses, respiratory therapists, and pediatricians) in charge of newborn care that working in the Neonatal Unit areas, maternity wards, surgery rooms responsible for the care of caesarean sections, and those of pediatric emergencies of University Hospital of La Sabana
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Structured debriefing assisted by videoIn the structured debriefing assisted by video, the process was based on the immediate review of the video, stopping and rewinding the recording as required. The debriefing session was conducted in the debriefing room of the simulation laboratory with an assigned time of 15 minutes. Each session was developed in three phases. The first phase, descriptive, in which each participant was encouraged to recount what they had lived and experienced, clarifying how the events unfolded, verifying the appropriate decisions and the errors committed in the scenario and the ways they could have solved them and corrected them. The second phase, analytical, the participant reflected on what occurred in the scenario, commenting on how their feelings were involved in the development of the case. The third phase, application or transference, in which the group was encouraged to draw conclusions from what had occurred, realizing an application of this experience in a real-life. | Other | Structured debriefing assisted by video |
| Structured oral debriefingIn the structured oral debriefing, the process was based by the mental search of their memories of what occurred. The debriefing session was conducted in the debriefing room of the simulation laboratory with an assigned time of 15 minutes. Each session was developed in three phases. The first phase, descriptive, in which each participant was encouraged to recount what they had lived and experienced, clarifying how the events unfolded, verifying the appropriate decisions and the errors committed in the scenario and the ways they could have solved them and corrected them. The second phase, analytical, the participant reflected on what occurred in the scenario, commenting on how their feelings were involved in the development of the case. The third phase, application or transference, in which the group was encouraged to draw conclusions from what had occurred, realizing an application of this experience in a real-life. | Other | Structured oral debriefing |
Primary outcome
Compliance percentage of the activities
Time frame: The checklist was applied by a reviewer blinded to the assignment of the type of debriefing by reviewing the video, on average 1 week after of the participation of the groups in the scenarios.
For the performance and evaluation score of the adherence of the teams to the resuscitation protocols, a review of the literature was performed for constructed a checklist that included cognitive/technical and behavioral aspects of individual performance and performance by profession in each of the scenarios. Each item of the tool was assigned a score of 1 if the evaluated activity was correctly performed, 0 if it was not performed correctly, and N/A if it did not apply for the scenario and/or for the profession. A compliance percentage (range 0% to 100%) of the activities evaluated by participant in the tool was obtained, summed the points obtained onto the possible total score. The higher percentage indicate better outcome.
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 30 Jul 2018.
- Background: PubMed 21937960Sawyer T, Sierocka-Castaneda A, Chan D, Berg B, Lustik M, Thompson M. Deliberate practice using simulation improves neonatal resuscitation performance. Simul Healthc. 2011 Dec;6(6):327-36. doi: 10.1097/SIH.0b013e31822b1307.
- Derived from this study: PubMed 30333050Gamboa OA, Agudelo SI, Maldonado MJ, Leguizamon DC, Cala SM. Evaluation of two strategies for debriefing simulation in the development of skills for neonatal resuscitation: a randomized clinical trial. BMC Res Notes. 2018 Oct 17;11(1):739. doi: 10.1186/s13104-018-3831-6.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Structured debriefing assisted by video and Structured oral debriefing in people with Asphyxia Neonatorum and Birth Injuries, run by Universidad de la Sabana.
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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Compliance percentage of the activities (time frame: The checklist was applied by a reviewer blinded to the assignment of the type of debriefing by reviewing the video, on average 1 week after of the participation of the groups in the scenarios.). 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 NCT03606278, which also lists 2 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 30 Jul 2018.