Nurse EducationNCT07229573
The Effectiveness of Serious Game-Based Training for Nursing Students in Postpartum Haemorrhage Management
A study testing Web-Based Serious Game in people with Nurse Education and Nursing Students, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the incremental effect of adding a web-based serious game to standard theoretical instruction on third-year nursing students' postpartum hemorrhage management knowledge, task-specific self-efficacy, and self-regulated learning. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nurse Education, Nursing Students, Postpartum Hemorrhage
- What is being tested?
- Web-Based Serious Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2025to 30 Dec 2025
- 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
- Enrollment as a third-year nursing student in the Obstetrics and Gynecology Nursing course.
- Voluntary agreement to participate and provision of electronic informed consent.
- Access to an internet-enabled smartphone, tablet, or laptop for using the web-based serious game.
Who cannot join
- Absence during the scheduled intervention session. Incomplete submission of the data collection forms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Serious Game-Based Training for Nursing Students in Postpartum Haemorrhage Management: A Randomised Controlled Trial
This randomized controlled trial evaluated the incremental effect of adding a web-based serious game to standard theoretical instruction on third-year nursing students' postpartum hemorrhage management knowledge, task-specific self-efficacy, and self-regulated learning. Using census recruitment, all 159 eligible students were invited, and 120 students consented and were randomly allocated in a 1:1 ratio to the intervention or control group (60 participants per group) using randomly permuted blocks of four. Both groups received the same three 40-minute theoretical sessions. The intervention group additionally completed an individual, self-paced, 30-50-minute browser-based serious game featuring a single branching postpartum hemorrhage scenario, clinical decision-making, and immediate physiological feedback. The control group received no additional educational activity before the immediate posttest assessment. Outcomes were assessed at baseline before randomization and immediately after the intervention or control condition. Outcome data were analyzed by an independent analyst blinded to group coding.Data will be collected using the PPK Management Knowledge and Skills Assessment Form and the PPK Management Self-Confidence Scale.
- Conditions
- Nurse Education, Nursing Students, Postpartum Hemorrhage, Nursing Care, Self-Efficacy, Game-Based Learning
- Being tested
- Web-Based Serious Game
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Serious GameOther
A browser-based serious game (Version 1.0) comprising a single branching clinical scenario on the recognition and management of primary postpartum hemorrhage. Participants made clinical decisions, observed the physiological consequences of their choices, and received immediate formative feedback. The game was completed individually in a single continuous attempt lasting approximately 30-50 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based Serious Game | Experimental | Participants received three 40-minute standard theoretical sessions on postpartum hemorrhage management and additionally completed an individual, self-paced, 30-50-minute browser-based serious game containing a single branching clinical scenario with clinical decision-making and immediate physiological feedback. Receives: Other: Web-Based Serious Game |
| Standard Theoretical Instruction Group | No intervention | Participants received the same three 40-minute standard theoretical sessions on postpartum hemorrhage management as the intervention group. They received no additional educational content or time- and attention-matched activity before the immediate posttest assessment. Access to the serious game was offered after all post-intervention outcome assessments had been completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Hemorrhage Management Knowledge Assessment Form (PHM-KAF)
The researcher-developed PHM-KAF is a 15-item multiple-choice assessment of knowledge and clinical decision-making accuracy related to postpartum hemorrhage risk assessment, etiology (the 4Ts), and evidence-based management. Each correct response is scored as 1 and each incorrect response as 0, yielding a total score ranging from 0 to 15. Higher scores indicate greater postpartum hemorrhage management knowledge. Content validity was evaluated by nine academic experts specializing in women's health and obstetric nursing (S-CVI/Ave = 0.96).
Measured: At baseline before randomization and immediately after the intervention or control condition.
Secondary outcomes (2)
Postpartum Hemorrhage Management Self-Efficacy Assessment Form (PHM-SEAF)
The researcher-developed PHM-SEAF is a 10-item, task-specific assessment form measuring nursing students' perceived self-efficacy in postpartum hemorrhage management. Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), yielding a total score ranging from 10 to 50. Higher scores indicate greater task-specific self-efficacy. Content validity was evaluated by nine academic experts specializing in women's health and obstetric nursing (S-CVI/Ave = 0.94).
Measured: At baseline before randomization and immediately after the intervention or control condition.
Self-Regulated Learning Scale for Clinical Nursing Practice
The Self-Regulated Learning Scale for Clinical Nursing Practice is a 16-item, 5-point Likert-type instrument comprising two subdimensions: Motivation and Learning Strategies. Total scores range from 16 to 80, with higher scores indicating stronger self-regulated learning.
Measured: At baseline before randomization and immediately after the intervention or control condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start5 Nov 2025
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse EducationStudies 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
- Two-arm, parallel-group randomized controlled trial with 1:1 allocation using randomly permuted blocks with a fixed block size of four. Participants and instructors were not blinded because of the overt nature of the educational intervention. Outcome data were analyzed by an independent analyst blinded to group coding.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahsen Demirhan, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229573
- Sponsor's protocol ID
- 06.10.2025
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Serious Game-Based Training for Nursing Students in Postpartum Haemorrhage Management: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07229573
- Acronym / sponsor ID
- 06.10.2025
- Conditions
- Nurse Education, Nursing Students, Postpartum Hemorrhage, Nursing Care, Self-Efficacy, Game-Based Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 17 Nov 2025 (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.
This randomized controlled trial evaluated the incremental effect of adding a web-based serious game to standard theoretical instruction on third-year nursing students' postpartum hemorrhage management knowledge, task-specific self-efficacy, and self-regulated learning. Using census recruitment, all 159 eligible students were invited, and 120 students consented and were randomly allocated in a 1:1 ratio to the intervention or control group (60 participants per group) using randomly permuted blocks of four. Both groups received the same three 40-minute theoretical sessions. The intervention group additionally completed an individual, self-paced, 30-50-minute browser-based serious game featuring a single branching postpartum hemorrhage scenario, clinical decision-making, and immediate physiological feedback. The control group received no additional educational activity before the immediate posttest assessment. Outcomes were assessed at baseline before randomization and immediately after the intervention or control condition. Outcome data were analyzed by an independent analyst blinded to group coding.Data will be collected using the PPK Management Knowledge and Skills Assessment Form and the PPK Management Self-Confidence Scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial with 1:1 allocation using randomly permuted blocks with a fixed block size of four. Participants and instructors were not blinded because of the overt nature of the educational intervention. Outcome data were analyzed by an independent analyst blinded to group coding.
| Arm | Type | Receives |
|---|---|---|
| Web-Based Serious Game | Experimental | Other: Web-Based Serious GameParticipants received three 40-minute standard theoretical sessions on postpartum hemorrhage management and additionally completed an individual, self-paced, 30-50-minute browser-based serious game containing a single branching clinical scenario with clinical decision-making and immediate physiological feedback. |
| Standard Theoretical Instruction Group | No intervention | –Participants received the same three 40-minute standard theoretical sessions on postpartum hemorrhage management as the intervention group. They received no additional educational content or time- and attention-matched activity before the immediate posttest assessment. Access to the serious game was offered after all post-intervention outcome assessments had been completed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Enrollment as a third-year nursing student in the Obstetrics and Gynecology Nursing course.
- Voluntary agreement to participate and provision of electronic informed consent.
- Access to an internet-enabled smartphone, tablet, or laptop for using the web-based serious game.
Key exclusion criteria (1 listed)
- Absence during the scheduled intervention session. Incomplete submission of the data collection forms.
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 |
|---|---|---|
| Web-Based Serious GameA browser-based serious game (Version 1.0) comprising a single branching clinical scenario on the recognition and management of primary postpartum hemorrhage. Participants made clinical decisions, observed the physiological consequences of their choices, and received immediate formative feedback. The game was completed individually in a single continuous attempt lasting approximately 30-50 minutes. | Other | Web-Based Serious Game |
Primary outcome
Postpartum Hemorrhage Management Knowledge Assessment Form (PHM-KAF)
Time frame: At baseline before randomization and immediately after the intervention or control condition.
The researcher-developed PHM-KAF is a 15-item multiple-choice assessment of knowledge and clinical decision-making accuracy related to postpartum hemorrhage risk assessment, etiology (the 4Ts), and evidence-based management. Each correct response is scored as 1 and each incorrect response as 0, yielding a total score ranging from 0 to 15. Higher scores indicate greater postpartum hemorrhage management knowledge. Content validity was evaluated by nine academic experts specializing in women's health and obstetric nursing (S-CVI/Ave = 0.96).
2 secondary outcomes
Postpartum Hemorrhage Management Self-Efficacy Assessment Form (PHM-SEAF)
Time frame: At baseline before randomization and immediately after the intervention or control condition.
Self-Regulated Learning Scale for Clinical Nursing Practice
Time frame: At baseline before randomization and immediately after the intervention or control condition.
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 1 Sep 2026.
- 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 Web-Based Serious Game in people with Nurse Education and Nursing Students, run by Sakarya 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 3 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 1 Sep 2026. 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?
Postpartum Hemorrhage Management Knowledge Assessment Form (PHM-KAF) (time frame: At baseline before randomization and immediately after the intervention or control condition.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.