NCT07304609

Brief Summary

Hospitalization can have traumatic effects on children and their families, highlighting the importance of trauma-informed care in pediatric nursing. Post-hospitalization trauma, anxiety, and depression are frequently observed in both children and parents, negatively affecting health outcomes and treatment adherence. Since trauma-informed care requires a child- and family-centered, safe, and sensitive approach, educating nursing students on this topic is essential. However, this training is often insufficient in nursing curricula, and its abstract and emotionally challenging nature may hinder students' learning. In this context, the LEGO® Serious Play® method, which helps concretize abstract experiences and supports interactive learning, may serve as an effective educational tool. This study aims to evaluate the effects of trauma-informed pediatric care education delivered through the LSP method on nursing students' knowledge, self-confidence, and satisfaction.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Dec 2025May 2026

Study Start

First participant enrolled

December 11, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

14 days

First QC Date

December 12, 2025

Last Update Submit

January 2, 2026

Conditions

Keywords

trauma informed carenursingstudenteducationSerious Play

Outcome Measures

Primary Outcomes (2)

  • TIC Provider Survey

    This form based on research findings on post-traumatic stress following traumatic medical events in children. The survey consists of 38 items and includes five categories: 1) knowledge about trauma-informed pediatric care (11 items); 2) attitudes and beliefs about trauma-informed pediatric care (6 items); 3) self-efficacy (10 items); 4) trauma-informed care practices (7 items); and 5) perceived barriers to implementing trauma-informed care (4 items). Items assessing knowledge, attitudes, self-efficacy, and perceived barriers were evaluated using 3- or 4-point Likert-type scales appropriate to each category; for example, potential barriers were rated as "not a barrier," "somewhat a barrier," or "significant barrier." Cronbach's alpha values were found to be in the moderate to excellent range for knowledge (0.66), attitude. Higher score indicates a higher level of trauma-informed care knowledge.

    2 weeks

  • Student Satisfaction and Self-Confidence in Learning Scale

    This scales Cronbach's alpha value was found to be 0.94 for the satisfaction subscale and 0.87 for the self-confidence subscale. The scale consists of two subscales: "Satisfaction with Current Learning" (5 items) and "Self-Confidence in Learning" (7 items), with items rated on a 5-point Likert scale. The total score is obtained by summing the responses to each item of the scale and dividing by the number of items. The minimum score is 1 and the maximum score is 5. A higher score indicates greater satisfaction and higher self-confidence.

    2 weeks

Study Arms (2)

LEGO® Serious Play

EXPERIMENTAL

One week after participants received a one-hour theoretical standard training, trauma-informed care was applied using the LEGO® Serious Play® method. Participants learn trauma-informed care principles and different developmental stages in a hands-on way by designing hospital models with LEGO® bricks. Unlike traditional teaching methods, this approach aims to enhance participants' creativity, engagement, and learning motivation.

Other: LEGO® Serious Play®

Standard Training

NO INTERVENTION

Participants received only a one-hour theoretical standard training about trauma-informed care.

Interventions

Participants learn trauma-informed care principles and different developmental stages in a hands-on way by designing hospital models with LEGO® bricks. Unlike traditional teaching methods, this approach aims to enhance participants' creativity, engagement, and learning motivation."

LEGO® Serious Play

Eligibility Criteria

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

You may qualify if:

  • Volunteering to participate in the study
  • Being enrolled in the Turkish program of the Nursing Department, Faculty of Health Sciences, Ankara Medipol University
  • Taking the Pediatric Health and Diseases Nursing course in the Fall semester of the 2025-2026 academic year

You may not qualify if:

  • Not volunteering to participate in the study
  • Being unable to actively participate in the implementation process
  • Incomplete completion of data collection instruments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Ankara, Turkey (Türkiye)

Location

Related Publications (27)

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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    PMID: 35462412BACKGROUND
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    PMID: 31759240BACKGROUND
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    PMID: 39674704BACKGROUND
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    PMID: 26571032BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    PMID: 16093522BACKGROUND
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    PMID: 28274664BACKGROUND
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    PMID: 28663106BACKGROUND
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    PMID: 38916767BACKGROUND
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    PMID: 35958723BACKGROUND
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    PMID: 34798581BACKGROUND
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    PMID: 37197854BACKGROUND
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    PMID: 38450296BACKGROUND
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    PMID: 31685457BACKGROUND

Central Study Contacts

Tutku KIRÇI TEMİZ, PhD Research Assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: LEGO® SERIOUS PLAY, education
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, PhD

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 26, 2025

Study Start

December 11, 2025

Primary Completion

December 25, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Data sharing carries the potential to compromise the privacy of participants; therefore, due to ethical responsibility, only anonymized and aggregate data will be published.

Locations