NCT07562867

Brief Summary

This study aims to evaluate the effect of a Health Belief Model (HBM)-based, artificial intelligence (AI)-supported gamified training program on nurses' knowledge and attitudes toward the prevention of sharps injuries. Sharps injuries remain a significant occupational risk for healthcare workers, particularly nurses, despite existing standard precautions. The study will be conducted in two phases. In the first phase, the validity and reliability of the Sharps Injury Prediction Scale will be tested in a nurse population. In the second phase, a quasi-experimental pretest-posttest control group design will be used to assess the effectiveness of the intervention. The study will be carried out in two hospitals from the same healthcare group located in different cities to prevent interaction between groups. A total of 36 nurses will be included, with 18 participants in the intervention group and 18 in the control group. The intervention group will receive a structured, HBM-based training program consisting of seven sessions incorporating AI-supported content, gamified scenarios, interactive materials, and feedback mechanisms to enhance engagement and promote behavior change. The control group will receive routine institutional training on sharps injury prevention. Data will be collected at baseline, immediately after the intervention, and two months later. Outcome measures include nurses' knowledge, attitudes toward safe sharps use, and sharps injury risk perception. It is expected that the AI-supported gamified training program will significantly improve knowledge, attitudes, and risk awareness compared to routine training. The findings may support the integration of innovative, theory-based educational interventions into institutional training programs to enhance occupational safety.

Trial Health

65
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Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Jun 2026

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

April 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 26, 2026

Last Update Submit

April 26, 2026

Conditions

Keywords

Sharps injuriesNursing education

Outcome Measures

Primary Outcomes (1)

  • Nurses' knowledge level regarding sharps injury prevention

    Knowledge level will be assessed using a structured knowledge questionnaire consisting of 25 items developed based on the literature. Higher scores indicate greater knowledge regarding sharps injury prevention.

    Baseline (pretest), immediately after the intervention (posttest), and 2 months after the intervention

Secondary Outcomes (2)

  • Attitudes toward safe use of sharps

    Baseline, immediately after the intervention, and 2 months after the intervention

  • Sharps injury risk perception and prediction score

    Baseline, immediately after the intervention, and 2 months after the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Nurses in the intervention group will receive a Health Belief Model-based, AI-supported gamified training program designed to improve knowledge and attitudes toward sharps injury prevention.

Behavioral: Experimental: Intervention Group

Control Group

ACTIVE COMPARATOR

Standard training provided by the institution, including lectures and question-answer sessions on sharps injury prevention.

Behavioral: control group

Interventions

A structured training program consisting of seven sessions, incorporating artificial intelligence-supported educational content, gamified scenarios, interactive videos, and digital feedback mechanisms to enhance learning and promote behavior change.

Intervention Group
control groupBEHAVIORAL

Standard training provided by the institution, including lectures and question-answer sessions on sharps injury prevention.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Registered nurses working in the participating hospitals
  • Working in the institution for at least 2 months (Phase 1) or newly employed within the last 1 month (Phase 2)
  • Willing to participate in the study
  • Able to use smartphone-based technologies
  • Providing written informed consent

You may not qualify if:

  • Having received prior training based on the Health Belief Model for sharps injury prevention
  • Previous professional nursing experience before current employment (for newly recruited nurses in Phase 2)
  • Being on leave during the data collection period
  • Failure to attend training sessions (intervention group)
  • Incomplete data collection forms
  • Withdrawal from the study at any stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Needlestick Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds, StabWounds, PenetratingWounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ziyafet Uğurlu, Professor

    Baskent University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

İsmail Kuşoğlu, PhD. Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study will use a non-randomized parallel group design with pretest, posttest, and two-month follow-up assessments. Groups will be assigned by hospital to prevent interaction between participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, PhD student

Study Record Dates

First Submitted

April 26, 2026

First Posted

May 1, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The study involves human participants, and sharing individual-level data may pose a risk to confidentiality despite anonymization. Data will be used solely for research purposes in accordance with ethical approval and institutional regulations.