NCT07669480

Brief Summary

Purpose: This study aims to evaluate the effects of an educational digital escape room game-based Psychological First Aid (PFA) training on the PFA self-efficacy and problem-solving levels of undergraduate midwifery students. Methods: The study will be conducted as a randomized controlled trial with a pretest, posttest, and follow-up design at the Health Sciences University (SBU), Hamidiye Faculty of Health Sciences, Department of Midwifery during the spring semester of the 2025-2026 academic year. Second-year midwifery students will be randomly assigned to either the intervention group or the control group using a stratified randomization method based on their Grade Point Average (GPA). Both groups will receive a standardized theoretical PFA training program. In addition to this training, the intervention group will participate in an interactive digital escape room game developed on the Genially platform, consisting of short web-based scenarios under 20 minutes. The control group will receive only the standard theoretical education. Data will be collected at baseline (Week 1), post-intervention (Week 3), and during follow-up phases using the Psychological First Aid Self-Efficacy Scale and the Problem Solving Inventory to compare the behavioral and educational outcomes between the two groups.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

June 3, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

15 days

First QC Date

June 3, 2026

Last Update Submit

June 22, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Psychological First Aid Self-Efficacy Scale Score Immediately After the Intervention

    The Psychological First Aid Self-Efficacy Scale is a 35-item self-report instrument used to evaluate the participants' perceived competence and preparedness in delivering acute psychological first aid during crises. All items are scored on a 5-point Likert-type scale (1 = Strongly Disagree to 5 = Strongly Agree). There are no reverse-scored items. The total score is calculated by summing all responses, ranging from a minimum score of 35 to a maximum score of 175. Higher total scores indicate a superior level of self-efficacy and better psychological readiness in implementing psychological first aid interventions, while lower scores indicate lower self-efficacy.

    Baseline (Day 1, prior to the start of the theoretical training) and immediately after the completion of the educational intervention phase (Week 2/Week 3 boundary, right after the last gaming/theoretical session).

  • Outcome Measure Title: Change from Baseline in Problem Solving Inventory (PSI) Score Immediately After the Intervention

    The Problem Solving Inventory (PSI), originally developed by Heppner and Petersen, is a 32-item self-report instrument that assesses individuals' cognitive perceptions of their own problem-solving behaviors and coping strategies. Items are scored on a 6-point Likert scale. Total scores on the inventory range from a minimum of 32 to a maximum of 192. In terms of clinical and behavioral interpretation, the scoring is inversely aligned: lower total scores indicate that the student perceives themselves as highly competent, sufficient, and successful in problem-solving skills. Conversely, higher total scores reflect a lower perception of problem-solving confidence and perceived insufficiency in coping with challenges.

    Baseline (Day 1, prior to the start of the theoretical training) and immediately after the completion of the educational intervention phase (Week 2/Week 3 boundary, right after the last gaming/theoretical session).

Study Arms (2)

Intervention Group (Game-Based PFA Training)

EXPERIMENTAL

Second-year midwifery students in this arm will receive both the standard theoretical training and the interactive digital escape room game.

Behavioral: Digital Escape Room Game via Genially

Control Group (Standard PFA Training)

ACTIVE COMPARATOR

Second-year midwifery students in this arm will receive only the standard theoretical training program during the study period. (Note: They will be cross-over given access to the digital game after all data collection is completed for ethical equity).

Other: Standardized Theoretical Psychological First Aid (PFA) Training

Interventions

An interactive, scenario-based educational digital escape room game developed on the Genially platform. The content consists of clinical and psychological emergency midwifery scenarios tailored to last no longer than 20 minutes per session to prevent cognitive overload. It focuses on active problem-solving, triage, and applying PFA principles under stress.

Intervention Group (Game-Based PFA Training)

A structured classroom-based theoretical training module developed in accordance with international guidelines and expert opinions.

Control Group (Standard PFA Training)

Eligibility Criteria

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

You may qualify if:

  • Volunteering to participate in the research.
  • Having internet access.
  • Having a smartphone.
  • Having taken the emergency care and first aid course.
  • Being an active 2nd-year student in the Midwifery Department of Hamidiye Faculty of Health Sciences, Health Sciences University.

You may not qualify if:

  • Being a passive student in the 2nd year of the Midwifery Department at Hamidiye Faculty of Health Sciences, Health Sciences University.
  • Not participating in educational practices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Desmoglein 1

Intervention Hierarchy (Ancestors)

DesmogleinsDesmosomal CadherinsCadherinsCell Adhesion MoleculesMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsAntigens, SurfaceAntigensBiological FactorsAutoantigens

Central Study Contacts

Yasemin AYDIN KARTAL Prof. Dr.

CONTACT

Sema AKER Res. Ass.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The research process will be conducted with a double-blind design; both participants and data collectors will be unaware of group assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized controlled double-blind experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 25, 2026

Study Start

June 15, 2026

Primary Completion

June 30, 2026

Study Completion

July 15, 2026

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share