NCT07229573

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 1, 2026

Status Verified

November 1, 2025

Enrollment Period

25 days

First QC Date

November 13, 2025

Last Update Submit

August 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    At baseline before randomization and immediately after the intervention or control condition.

Secondary Outcomes (2)

  • Postpartum Hemorrhage Management Self-Efficacy Assessment Form (PHM-SEAF)

    At baseline before randomization and immediately after the intervention or control condition.

  • Self-Regulated Learning Scale for Clinical Nursing Practice

    At baseline before randomization and immediately after the intervention or control condition.

Study Arms (2)

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.

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.

Interventions

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.

Web-Based Serious Game

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Absence during the scheduled intervention session. Incomplete submission of the data collection forms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Adapazarı, Sakarya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

November 5, 2025

Primary Completion

November 30, 2025

Study Completion

December 30, 2025

Last Updated

September 1, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations