NCT07229573

Brief Summary

This randomised controlled trial aims to evaluate the effectiveness of serious game-based training for postpartum haemorrhage (PPH) management among third-year nursing students. The study employs a pre-test-post-test design with two parallel groups: an experimental group (game-based education) and a control group (traditional education). The sample size was determined by power analysis to be 70 students in total, with 35 students in each group. Participants will be assigned in a 1:1 ratio by computer-assisted block randomisation by a person independent of the research team; students and instructors will not be blinded, but the biostatistician performing the data analysis will be blinded. The intervention group will first receive traditional education, followed by gamification-based education including nursing interventions in the management of PPB; the control group will receive only traditional education. Data will be collected using the PPK Management Knowledge and Skills Assessment Form and the PPK Management Self-Confidence Scale.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

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
recruiting

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

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

25 days

First QC Date

November 13, 2025

Last Update Submit

November 13, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Postpartum Haemorrhage Management Knowledge and Skills

    The form was developed by researchers for this study based on the literature. The assessment form, consisting of 20 multiple-choice questions, was prepared to evaluate the student's knowledge and skill levels in PPB management. The opinions of three experts in the field of Women's Health and Obstetric Nursing and Midwifery were sought to assess the comprehensiveness, clarity, and scientific appropriateness of the questions on the form. In the Postpartum Haemorrhage Management Knowledge and Skills Assessment Form, each correct answer is scored as '5' and each incorrect answer as '0'. The maximum score that can be obtained from the form is "100", and the minimum score is '0'.

    pre-education and within 1 week after training

  • Self-Confidence Scale in PPH Management

    The form was developed by researchers for this study based on the literature. The assessment form, consisting of 10 multiple-choice questions, was prepared to evaluate the student's level of self-efficacy in PPH management. Three experts in the field of Women's Health and Obstetric Nursing and Midwifery were consulted to assess the comprehensiveness, clarity, and scientific appropriateness of the questions on the form. The scale is a 5-point Likert scale (1=Strongly disagree 2=Disagree 3=Undecided 4=Agree 5=Strongly agree)

    pre-education and within 1 week after training

  • Self-Regulated Learning Scale for Clinical Nursing Practice

    The scale was developed by Satoko Iyama and Hitomi Maeda in 2017 and adapted into Turkish by Şenol and Orgun in 2018. It consists of 16 items in a 5-point Likert scale type, comprising two sub-dimensions: 'Motivation' and 'Learning Strategies'. The scale is structured as follows: 1. Motivation 2. Learning Strategies It is a 5-point Likert-type scale comprising 16 items and two subscales: 'Motivation' and "Learning Strategies". The minimum score achievable on the entire scale is 16, with a maximum score of 80, and Cronbach's α was determined to be 0.898.

    pre-education and within 1 week after training

Study Arms (2)

Gamification Group

EXPERIMENTAL

Students in the intervention group will first receive traditional theoretical and practical training in the department's curriculum using standard methods; they will then participate in the developed serious game application.

Other: Gamification

Control Group

NO INTERVENTION

Students in the control group will only receive theoretical and practical lessons included in the department curriculum using traditional teaching methods during the study period; no additional intervention will be applied. The scope of education will be limited to the existing course content, and no additional simulation/game-based activities will be conducted. In accordance with ethical principles, the same serious game application will be offered to the students in the control group after the research is completed, and these students will also be provided with the opportunity to benefit from the game.

Interventions

Students in the intervention group will first receive traditional theoretical and practical training in the department's curriculum using standard methods; they will then participate in the developed serious game application.

Gamification Group

Eligibility Criteria

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

You may qualify if:

  • a) Third-year nursing students taking the Obstetrics and Gynaecology Nursing course, b) Not experiencing any verbal or written communication problems, c) Not being an exchange student, d) Being willing to provide written consent before participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Adapazarı, Sakarya, Turkey (Türkiye)

RECRUITING

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

Central Study Contacts

Ahsen Demirhan Kayacik, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
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

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations