NCT07418515

Brief Summary

The goal of this clinical trial is to learn whether therapeutic story reading reduces fear levels, problematic media use, and parental stress in hospitalized preschool children. It will also examine the effectiveness of this intervention when integrated into routine nursing care. The main questions it aims to answer are: Does therapeutic story reading reduce children's fear of nursing interventions and medical materials? Does therapeutic story reading reduce problematic media use in hospitalized children? Does therapeutic story reading reduce parental stress levels? Researchers will compare a therapeutic story reading intervention to routine care to determine whether the intervention improves psychological outcomes in hospitalized children and their parents. Participants will: Be randomly assigned to either the intervention group or the control group Complete baseline assessments before the intervention (Intervention group) Participate in therapeutic story reading sessions for three consecutive days (Control group) Receive routine hospital care Complete post-intervention assessments after the study period Children's fear levels will be assessed using the Fear of Children Against Nursing Interventions and Used Materials Scale (FCANIM). Parental outcomes will be measured using the Problematic Media Use Measure (PMUM) and the Parental Stress Scale (PSS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

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

June 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

February 11, 2026

Last Update Submit

February 18, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • The Scale Of Fear In Children Against Nursing Interventions And Used Materials

    Fear levels are assessed using the Fear of Children Against Nursing Interventions and Used Materials Scale (FCANIM), a 18-item instrument developed to evaluate children's fear of nursing procedures and commonly used medical materials. The scale consists of two subdimensions: (1) fear of frequently encountered materials and (2) fear of less frequently encountered materials. Each item includes a visual representation of a nursing intervention or medical material (e.g., stethoscope, thermometer). Children rate their level of fear for each image using a five-point Likert-type scale illustrated with facial expressions representing increasing levels of fear. Total scores range from 18 to 90. Higher scores indicate higher levels of fear toward nursing interventions and medical materials, while lower scores indicate lower fear levels. The internal consistency of the scale is high, with Cronbach's alpha coefficients ranging from 0.89 to 0.93 for the subdimensions and 0.94 for the total scale.

    At baseline (prior to the intervention) and immediately after completion of the 3-day intervention period.

  • Problematic Media Use Measure

    Problematic media use is assessed using the 9-item Problematic Media Use Scale - Short Form (PMUS-SF). The scale evaluates problematic use of screen-based media devices, including television, computers, tablets, and smartphones. Items are rated on a 5-point Likert scale based on the frequency of screen-use behaviors. The total score is calculated by summing the item scores and dividing by nine. Final scores range from 1 to 5. Higher scores indicate higher levels of problematic media use, whereas lower scores indicate lower levels of problematic media use. The original scale demonstrated high internal consistency (Cronbach's alpha = 0.92). In the present study, Cronbach's alpha was 0.78 at pre-test and 0.80 at post-test.

    At baseline (prior to the intervention) and immediately after completion of the 3-day intervention period.

  • Parental Stress Scale

    Parental stress is assessed using the 16-item Parental Stress Scale (PSS). The scale consists of four subdimensions: parental stressors, loss of control, satisfaction, and rewards. Items are rated on a 5-point Likert-type scale. Total scores range from 16 to 80. Higher scores indicate higher levels of parental stress, whereas lower scores indicate lower levels of parental stress. In the Turkish validation study, Cronbach's alpha coefficients for the subscales ranged between 0.70 and 0.76, and 0.81 for the total scale score. In the present study, Cronbach's alpha was 0.73 at pre-test and 0.76 at post-test.

    At baseline (prior to the intervention) and immediately after completion of the 3-day intervention period.

Study Arms (2)

Storytelling group

EXPERIMENTAL

Participants in the intervention arm received a structured therapeutic story reading intervention during their hospitalization in the pediatric ward. The intervention was implemented on three consecutive days during the child's inpatient stay, at a time that did not interfere with medical treatment or nursing care, and was conducted in the child's hospital room. One therapeutic storybook was read per day (three books in total). The intervention was primarily delivered by a pediatric nursing specialist researcher. Three therapeutic storybooks specifically selected to positively influence the hospitalization experience were used: "I Have a Fever" - aimed at helping children understand fever and related nursing interventions. "From A to Z: Hospital (Interactive Alphabet)" - aimed at familiarizing children with hospital equipment and healthcare professionals. "Sometimes It Happens: I Guess I Felt a Little" - aimed at helping children recognize and express fear related to hospitalization.

Behavioral: Therapeutic Story Telling

Routine care group

OTHER

Participants in the routine care arm received routine pediatric ward care without therapeutic story reading sessions.

Other: routine care

Interventions

The intervention consists of a structured, developmentally appropriate therapeutic story reading program designed specifically for hospitalized preschool children (4-6 years of age). The program is implemented individually in the child's hospital room over three consecutive days, with one therapeutic storybook read per day. The distinguishing features of this intervention are: (1)its structured and sequential delivery during hospitalization, (2)the use of carefully selected therapeutic storybooks targeting fear of nursing interventions, hospital equipment, and emotional expression, and (3)its implementation under the supervision of a pediatric nursing specialist to ensure consistency and therapeutic intent. Unlike routine care, the intervention systematically addresses children's hospitalization-related fears and emotional responses. The content of the selected books is developmentally appropriate and suitable for helping children understand medical procedures (e.g., fever management).

Storytelling group

Participants in the routine care arm received routine pediatric ward care without therapeutic story reading sessions.

Routine care group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4-6 years
  • Able to speak and understand Turkish
  • Hospitalized in the pediatric ward for at least 3 days
  • No diagnosed cognitive impairment
  • Written informed consent provided by a parent or legal guardian to participate in the study

You may not qualify if:

  • Children who do not speak or understand Turkish
  • Hospital stay expected to be less than 3 days
  • Presence of diagnosed cognitive impairment or developmental disorder that would interfere with participation
  • Children whose parent or legal guardian does not provide informed consent
  • Children with a medical condition requiring intensive care or isolation precautions that would prevent participation in the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Center, 78100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

June 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 4, 2025

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be publicly shared in order to protect participant confidentiality and comply with data protection regulations. De-identified data that support the findings of this study may be made available upon reasonable request to the corresponding author, subject to ethical approval and institutional regulations.

Locations