Neonatal Respiratory DistressNCT05257499
In-person Versus Online Debriefing in HBB
A study testing On line debriefing in people with Neonatal Respiratory Distress, run by American University of Beirut Medical Center at 2 sites in Lebanon.
Trial summary
The objective of this study is to assess the effectiveness of online formative feedback and debriefing on nursing and medical students enrolled in the HBB course in comparison to traditional face-to-face feedback. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neonatal Respiratory Distress
- What is being tested?
- On line debriefing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesLebanon
- Study dates
- 5 Oct 2021to 31 Mar 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nurses and medical students
Who cannot join
- Attended resuscitation course
Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites
American University of Beirut
Beirut, Beirut, 1107 2020
American University of Beirut
Beirut, Hamra, 1107 2020
About this study
Official title: In-person Versus Online Debriefing in the Simulation Sessions of the Helping Babies Breathe Course: A Randomized Controlled Trial
The objective of this study is to assess the effectiveness of online formative feedback and debriefing on nursing and medical students enrolled in the HBB course in comparison to traditional face-to-face feedback. The working hypothesis is that online feedback and debriefing during hands-on training sessions are as effective as face-to-face feedback and debriefing in teaching clinical skills to medical and nursing students.
Read the detailed description
Online learning has become an integral part of education, especially during the ongoing COVID19 pandemic that has imposed a limit on live interactions. This observation holds true in the medical education system which uses the flipped classroom model to teach essential practical skills. Studies have shown that this model is associated with improved learning and student satisfaction. In such a model, debriefing and feedback comprise a main part of the teaching process, and these interactions are usually conducted in person. One helpful skill offered to nursing and medical students is Helping Babies Breathe (HBB), which is an evidence-based educational program training first-line birth attendants to initiate effective resuscitation of a newborn in the first minute of life. The investigators propose to incorporate online feedback as part of the HBB course at the American University of Beirut. In this non-inferiority randomized controlled trial, the investigators will study the effectiveness of online formative feedback and debriefing on nursing and medical students enrolled in the HBB course in comparison to traditional face-to-face feedback. The working hypothesis is that internet-based live feedback and debriefing are as effective as face-to-face interactions when teaching clinical skills to nursing and medical students. This work will aid in developing a reliable online curriculum that can be extrapolated to other courses and institutions, thus broadening the reach of medical education in the times of physical distancing.
- Conditions
- Neonatal Respiratory Distress
- Being tested
- On line debriefing
- Keywords
- Online debriefing, In person debriefing, Helping babies breathe, Debriefing, Simulation training
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On line debriefingBehavioural
Online Debriefing in the Simulation Sessions of the Helping Babies Breathe Course
| Study group | Role | What they receive |
|---|---|---|
| On line debfriefing | Experimental | Participants in this group will practice the skills taught as above but in the presence of the same certified instructor who will guide them throughout all the steps of HBB using a virtual platform (Webex® or Zoom®). Receives: Behavioral: On line debriefing |
| In person debriefing | No intervention | Participants in this group will practice the skills taught in the virtual class on the neonatal mannequin. They are expected to work as a small group of 3 to 4 at a time. They will receive coaching, debriefing and feedback from a certified instructor who will conduct the traditional in-person training with face-to-face feedback and debriefing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Structured Clinical Examination (OSCE) score
The OSCE of all participants will be videotaped without showing any identifier. Grading of the OSCE will be done by an independent instructor blinded to group assignments.
OSCE is graded over 100. Grades equal of higher than 80% are considered for passing.
Measured: One month
Secondary outcomes (1)
Student satisfaction
A questionnaire accompanied with a standardized Debriefing Assessment for Simulation in Healthcare Student Version will be used.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start5 Oct 2021
- Primary completion10 Feb 2022
- Study completion31 Mar 2022
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 Neonatal Respiratory DistressStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Charafeddine, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257499
- Sponsor's protocol ID
- SBS-2021-0193
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Odongkara B, Tylleskar T, Pejovic N, Achora V, Mukunya D, Ndeezi G, Tumwine JK, Nankabirwa V. Adding video-debriefing to Helping-Babies-Breathe training enhanced retention of neonatal resuscitation knowledge and skills among health workers in Uganda: a cluster randomized trial. Glob Health Action. 2020 Dec 31;13(1):1743496. doi: 10.1080/16549716.2020.1743496.
PubMed 32524895Sait MS, Siddiqui Z, Ashraf Y. Advances in medical education and practice: student perceptions of the flipped classroom. Adv Med Educ Pract. 2017 May 2;8:317-320. doi: 10.2147/AMEP.S133328. eCollection 2017. No abstract available.
PubMed 28496377Mehta NB, Hull AL, Young JB, Stoller JK. Just imagine: new paradigms for medical education. Acad Med. 2013 Oct;88(10):1418-23. doi: 10.1097/ACM.0b013e3182a36a07.
PubMed 23969368Kfoury P, Maalouf F, Nasser F, Gulgulian T, Charafeddine L. In-Person Versus Online Training in Simulations of Helping Babies Breathe: A Randomized Controlled Trial. Cureus. 2024 Jul 16;16(7):e64677. doi: 10.7759/cureus.64677. eCollection 2024 Jul.
PubMed 39149645
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-person Versus Online Debriefing in the Simulation Sessions of the Helping Babies Breathe Course: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05257499
- Acronym / sponsor ID
- SBS-2021-0193
- Conditions
- Neonatal Respiratory Distress
- Keywords
- Online debriefing, In person debriefing, Helping babies breathe, Debriefing, Simulation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 25 Feb 2022 (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.
The objective of this study is to assess the effectiveness of online formative feedback and debriefing on nursing and medical students enrolled in the HBB course in comparison to traditional face-to-face feedback. The working hypothesis is that online feedback and debriefing during hands-on training sessions are as effective as face-to-face feedback and debriefing in teaching clinical skills to medical and nursing students.
Detailed description
Online learning has become an integral part of education, especially during the ongoing COVID19 pandemic that has imposed a limit on live interactions. This observation holds true in the medical education system which uses the flipped classroom model to teach essential practical skills. Studies have shown that this model is associated with improved learning and student satisfaction. In such a model, debriefing and feedback comprise a main part of the teaching process, and these interactions are usually conducted in person. One helpful skill offered to nursing and medical students is Helping Babies Breathe (HBB), which is an evidence-based educational program training first-line birth attendants to initiate effective resuscitation of a newborn in the first minute of life. The investigators propose to incorporate online feedback as part of the HBB course at the American University of Beirut. In this non-inferiority randomized controlled trial, the investigators will study the effectiveness of online formative feedback and debriefing on nursing and medical students enrolled in the HBB course in comparison to traditional face-to-face feedback. The working hypothesis is that internet-based live feedback and debriefing are as effective as face-to-face interactions when teaching clinical skills to nursing and medical students. This work will aid in developing a reliable online curriculum that can be extrapolated to other courses and institutions, thus broadening the reach of medical education in the times of physical distancing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On line debfriefing | Experimental | Behavioral: On line debriefingParticipants in this group will practice the skills taught as above but in the presence of the same certified instructor who will guide them throughout all the steps of HBB using a virtual platform (Webex® or Zoom®). |
| In person debriefing | No intervention | –Participants in this group will practice the skills taught in the virtual class on the neonatal mannequin. They are expected to work as a small group of 3 to 4 at a time. They will receive coaching, debriefing and feedback from a certified instructor who will conduct the traditional in-person training with face-to-face feedback and debriefing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Nurses and medical students
Key exclusion criteria (1 listed)
- Attended resuscitation course
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 |
|---|---|---|
| On line debriefingOnline Debriefing in the Simulation Sessions of the Helping Babies Breathe Course | Behavioural | On line debfriefing |
Primary outcome
Objective Structured Clinical Examination (OSCE) score
Time frame: One month
The OSCE of all participants will be videotaped without showing any identifier. Grading of the OSCE will be done by an independent instructor blinded to group assignments. OSCE is graded over 100. Grades equal of higher than 80% are considered for passing.
1 secondary outcome
Student satisfaction
Time frame: One month
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 3 Apr 2025.
- Background: PubMed 32524895Odongkara B, Tylleskar T, Pejovic N, Achora V, Mukunya D, Ndeezi G, Tumwine JK, Nankabirwa V. Adding video-debriefing to Helping-Babies-Breathe training enhanced retention of neonatal resuscitation knowledge and skills among health workers in Uganda: a cluster randomized trial. Glob Health Action. 2020 Dec 31;13(1):1743496. doi: 10.1080/16549716.2020.1743496.
- Background: PubMed 28496377Sait MS, Siddiqui Z, Ashraf Y. Advances in medical education and practice: student perceptions of the flipped classroom. Adv Med Educ Pract. 2017 May 2;8:317-320. doi: 10.2147/AMEP.S133328. eCollection 2017. No abstract available.
- Background: PubMed 23969368Mehta NB, Hull AL, Young JB, Stoller JK. Just imagine: new paradigms for medical education. Acad Med. 2013 Oct;88(10):1418-23. doi: 10.1097/ACM.0b013e3182a36a07.
- Derived from this study: PubMed 39149645Kfoury P, Maalouf F, Nasser F, Gulgulian T, Charafeddine L. In-Person Versus Online Training in Simulations of Helping Babies Breathe: A Randomized Controlled Trial. Cureus. 2024 Jul 16;16(7):e64677. doi: 10.7759/cureus.64677. eCollection 2024 Jul.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On line debriefing in people with Neonatal Respiratory Distress, run by American University of Beirut Medical Center at 2 sites in Lebanon.
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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. 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?
Objective Structured Clinical Examination (OSCE) score (time frame: One month). 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 NCT05257499, 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 3 Apr 2025.