NCT07446920

Brief Summary

This randomized controlled trial aims to evaluate the effect of an artificial intelligence-driven mobile application on nurses' knowledge and attitudes toward atraumatic care for hospitalized children. Participants, who are pediatric nurses, will be randomly assigned to either the intervention group, using the mobile application, or the control group receiving standard education. The primary outcomes are improvements in nurses' knowledge and attitudes, measured after the intervention. The study seeks to determine whether the mobile application enhances nurses' competence in providing atraumatic care compared to usual training methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 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

December 29, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

February 25, 2026

Last Update Submit

February 25, 2026

Conditions

Keywords

Atraumatic Care, Pediatric Nursing, Hospitalized Children, Nursing Education, AI, Mobile Application, RCT

Outcome Measures

Primary Outcomes (1)

  • Nurses' Knowledge about Atraumatic Care

    Change in nurses' knowledge scores regarding atraumatic care for hospitalized children, measured using a validated knowledge questionnaire administered before and after the AI-driven mobile application intervention.

    Pre-test and immediately post-intervention (after completing the mobile application modules).

Study Arms (2)

Nurses Receiving Atraumatic Care Training"

EXPERIMENTAL

Participants receive the AI-driven mobile application containing educational modules on atraumatic care, an interactive AI-based chat for at least three questions per module, module quizzes of 10 AI-generated questions, and a final assessment of 25 questions covering all modules. Completion of each module and quiz is required to advance

Behavioral: Atraumatic Care Training Program

Control group

OTHER

Nurses in this group will continue their routine practice without receiving any additional training, mobile application, or educational program. This group serves as a comparison to evaluate the effect of the AI-driven mobile application on the experimental group. Participants follow standard hospital protocols and provide care as usual, without exposure to the study intervention.

Behavioral: No Intervention / Standard Care

Interventions

The intervention consisted of an AI-driven mobile application designed to enhance nurses' knowledge and attitudes toward atraumatic care for hospitalized children. The application included educational modules covering principles, benefits, and purposes of atraumatic care. Each module provided AI-generated content and an interactive chat feature, requiring participants to ask at least three questions before unlocking a module-specific quiz. Participants completed all modules over one week, followed by a final assessment of 25 AI-generated questions covering all modules

Nurses Receiving Atraumatic Care Training"

Nurses in this group will continue their routine practice without receiving any additional training, mobile application, or educational program. Participants will provide pediatric care according to standard hospital protocols. This group serves as a comparison to evaluate the effect of the AI-driven mobile application on the experimental group.

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The study included nurses who:
  • Work in the participating units and provide direct nursing care to children or neonates.
  • Own a smartphone and are capable of using it (as the intervention is delivered via a mobile application).
  • Agree to participate and provide written informed consent

You may not qualify if:

  • Nurses were excluded if they:
  • Perform only administrative tasks (e.g., statistics/records) without providing direct patient care.
  • Are expected to take long-term leave during the intervention/follow-up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hospital

Baghdad, Iraq

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open-label study; no masking applied to participants, care providers, investigators, or outcome assessors.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the intervention group receiving the AI-driven mobile application or the control group receiving usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effect of Artificial Intelligence-Driven Mobile Application on Nurses' Knowledge and Attitude toward Atraumatic Care for Hospitalized Children: A Randomized Controlled Trial

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

December 29, 2025

Primary Completion

February 2, 2026

Study Completion

February 2, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations