- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07229573
The Effectiveness of Serious Game-Based Training for Nursing Students in Postpartum Haemorrhage Management
August 28, 2026 updated by: Ahsen Demirhan, Sakarya University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sakarya
-
Adapazarı, Sakarya, Turkey (Türkiye)
- Sakarya University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
Absence during the scheduled intervention session. Incomplete submission of the data collection forms.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-Based Serious Game
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.
|
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.
|
|
No Intervention: Standard Theoretical Instruction Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
At baseline before randomization and immediately after the intervention or control condition.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum Hemorrhage Management Self-Efficacy Assessment Form (PHM-SEAF)
Time Frame: At baseline before randomization and immediately after the intervention or control condition.
|
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).
|
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.
|
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.
|
At baseline before randomization and immediately after the intervention or control condition.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 5, 2025
Primary Completion (Actual)
November 30, 2025
Study Completion (Actual)
December 30, 2025
Study Registration Dates
First Submitted
November 13, 2025
First Submitted That Met QC Criteria
November 13, 2025
First Posted (Actual)
November 17, 2025
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 28, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06.10.2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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