Newborn; VitalityNCT04623411
Use of Serious Game Simulation on Newborn Resuscitation Education
A study testing Neonatal resuscitation training with classical method and serious game simulation method in people with Newborn; Vitality, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Neonatal death is one of the important indicators showing the development level of countries. Many newborn deaths are preventable. Preventable neonatal deaths arise from events such as birth asphyxia at the time of delivery. Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Newborn; Vitality
- What is being tested?
- Neonatal resuscitation training with classical method and serious game simulation method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 9 Mar 2021
- 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 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students who are volunteers, Those who attend the Neonatal Nursing Course, Nursing students in the 3rd grade, Students with laptops
Who cannot join
- Those with neonatal resuscitation certificate, Students without internet access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Serious Game Simulation on Newborn Resuscitation Education of Nursing Students
Neonatal death is one of the important indicators showing the development level of countries. Many newborn deaths are preventable. Preventable neonatal deaths arise from events such as birth asphyxia at the time of delivery. Nursing students receive neonatal resuscitation training with classical training methods and graduate without the opportunity to experience it in a clinical setting. The aim of the study is to evaluate the effectiveness of web-based serious game simulation method in neonatal resuscitation training given to nursing students.
Read the detailed description
The study was planned as a randomized controlled trial with a single blind, pretest-posttest design. This study will be conducted in the Fall Semester of the 2020-2021 Academic Year with nursing students studying in the 3rd grade of Akdeniz University Faculty of Nursing between October and December 2020. An intervention and control group (intervention group: 50, control group: 50) will be formed from 100 students who accepted to participate in the study. Participants will be randomly allocated to one of the two groups. Pre-test and post-test will be applied to both groups before and after the training. Neonatal resuscitation training will be given online to the intervention and control group. After the theoretical training, web-based neonatal resuscitation serious game simulation will be applied to the intervention group. Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p <0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz Universit It is predicted that the new information obtained from the data of the research will guide the methods used in education and new researches.
- Conditions
- Newborn; Vitality
- Being tested
- Neonatal resuscitation training with classical method and serious game simulation method, Control Group
- Keywords
- Newborn Resuscitation, Simulation, Serious game, Nursing Student
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal resuscitation training with classical method and serious game simulation methodBehavioural
After the theoretical training, the participants will be given technical information on the use of web-based neonatal resuscitation serious game simulation method.
Each participant will be asked to apply this method at least three times.
Control GroupBehavioural
Neonatal resuscitation training with classical method
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Neonatal resuscitation training with classical method and serious game simulation method Receives: Behavioral: Neonatal resuscitation training with classical method and serious game simulation method |
| Control Group | Experimental | Neonatal resuscitation training with classical method. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal resuscitation knowledge level assessment questionnaire
This 15-item multiple-choice questionnaire was developed by the researchers to evaluate the knowledge level of the participants. Each question will be evaluated as correct answer = 1 point, wrong answer = 0 points. Participants will fill in online before and after the training.
Measured: Immediately before training and one week after training completion
Evaluation of Newborn Resuscitation Practice Skills
Serious game simulation software will be used to Assess Newborn Resuscitation Practice Skill. Participants will be expected to practice web-based neonatal resuscitation with serious game simulation and their skills will be evaluated. Each correct practice will be evaluated as sufficient 1 point and incorrect practice will be evaluated as 0 points.
Measured: Immediately before training and one week after training completion
Secondary outcomes (1)
Student Satisfaction and Self-Confidence in Learning Scale
The scale consists of two sub-dimensions, "satisfaction with learning" and "self-confidence", in five-point Likert type, and a total of 13 items. There are five items in the satisfaction with learning sub-dimension and eight items in the self-confidence sub-dimension. Internal consistency coefficient of the scale: 0,90 The internal consistency coefficient of student satisfaction is 0.89, and the self-confidence in learning sub-dimension is 0.83.
Measured: One week after training completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Oct 2020
- Primary completion29 Nov 2020
- Study completion9 Mar 2021
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 Newborn; VitalityStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was pretest-posttest design, randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sureyya Sarvan, PhD, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623411
- Sponsor's protocol ID
- 5154
- Status last verified
- Jul 2021
- First submitted
- 4 Nov 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
PubMed 26473001Ghoman SK, Cutumisu M, Schmolzer GM. Simulation-Based Summative Assessment of Neonatal Resuscitation Providers Using the RETAIN Serious Board Game-A Pilot Study. Front Pediatr. 2020 Jan 31;8:14. doi: 10.3389/fped.2020.00014. eCollection 2020.
PubMed 32083041
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Serious Game Simulation on Newborn Resuscitation Education of Nursing Students
- ClinicalTrials.gov ID
- NCT04623411
- Acronym / sponsor ID
- 5154
- Conditions
- Newborn; Vitality
- Keywords
- Newborn Resuscitation, Simulation, Serious game, Nursing Student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 29 Nov 2020 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 10 Nov 2020 (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.
Neonatal death is one of the important indicators showing the development level of countries. Many newborn deaths are preventable. Preventable neonatal deaths arise from events such as birth asphyxia at the time of delivery. Nursing students receive neonatal resuscitation training with classical training methods and graduate without the opportunity to experience it in a clinical setting. The aim of the study is to evaluate the effectiveness of web-based serious game simulation method in neonatal resuscitation training given to nursing students.
Detailed description
The study was planned as a randomized controlled trial with a single blind, pretest-posttest design. This study will be conducted in the Fall Semester of the 2020-2021 Academic Year with nursing students studying in the 3rd grade of Akdeniz University Faculty of Nursing between October and December 2020. An intervention and control group (intervention group: 50, control group: 50) will be formed from 100 students who accepted to participate in the study. Participants will be randomly allocated to one of the two groups. Pre-test and post-test will be applied to both groups before and after the training. Neonatal resuscitation training will be given online to the intervention and control group. After the theoretical training, web-based neonatal resuscitation serious game simulation will be applied to the intervention group. Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p <0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz Universit It is predicted that the new information obtained from the data of the research will guide the methods used in education and new researches.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This was pretest-posttest design, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Neonatal resuscitation training with classical method and serious game simulation methodNeonatal resuscitation training with classical method and serious game simulation method |
| Control Group | Experimental | Behavioral: Control GroupNeonatal resuscitation training with classical method. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Students who are volunteers, Those who attend the Neonatal Nursing Course, Nursing students in the 3rd grade, Students with laptops
Key exclusion criteria (1 listed)
- Those with neonatal resuscitation certificate, Students without internet access
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 |
|---|---|---|
| Neonatal resuscitation training with classical method and serious game simulation methodAfter the theoretical training, the participants will be given technical information on the use of web-based neonatal resuscitation serious game simulation method. Each participant will be asked to apply this method at least three times. | Behavioural | Intervention Group |
| Control GroupNeonatal resuscitation training with classical method | Behavioural | Control Group |
Primary outcome
Neonatal resuscitation knowledge level assessment questionnaire
Time frame: Immediately before training and one week after training completion
This 15-item multiple-choice questionnaire was developed by the researchers to evaluate the knowledge level of the participants. Each question will be evaluated as correct answer = 1 point, wrong answer = 0 points. Participants will fill in online before and after the training.
Evaluation of Newborn Resuscitation Practice Skills
Time frame: Immediately before training and one week after training completion
Serious game simulation software will be used to Assess Newborn Resuscitation Practice Skill. Participants will be expected to practice web-based neonatal resuscitation with serious game simulation and their skills will be evaluated. Each correct practice will be evaluated as sufficient 1 point and incorrect practice will be evaluated as 0 points.
1 secondary outcome
Student Satisfaction and Self-Confidence in Learning Scale
Time frame: One week after training completion
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 23 Jul 2021.
- Background: PubMed 26473001Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
- Results publication: PubMed 32083041Ghoman SK, Cutumisu M, Schmolzer GM. Simulation-Based Summative Assessment of Neonatal Resuscitation Providers Using the RETAIN Serious Board Game-A Pilot Study. Front Pediatr. 2020 Jan 31;8:14. doi: 10.3389/fped.2020.00014. eCollection 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neonatal resuscitation training with classical method and serious game simulation method in people with Newborn; Vitality, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 23 Jul 2021. 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 Turkey (Türkiye). 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?
Neonatal resuscitation knowledge level assessment questionnaire (time frame: Immediately before training and one week after training completion). The study lists 2 primary outcomes in all. 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 NCT04623411, 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 23 Jul 2021.