- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418515
Impact of Therapeutic Storytelling on Fear, Screen Time, and Parental Stress Among Hospitalized Children (THERASTORY)
Impact of Therapeutic Storytelling on Fear, Screen Time, and Parental Stress Among Hospitalized Children: A Randomized Controlled Trial
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Center
-
Karabük, Center, Turkey (Türkiye), 78100
- Karabuk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Storytelling group
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. |
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).
|
|
Other: Routine care group
Participants in the routine care arm received routine pediatric ward care without therapeutic story reading sessions.
|
Participants in the routine care arm received routine pediatric ward care without therapeutic story reading sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Scale Of Fear In Children Against Nursing Interventions And Used Materials
Time Frame: At baseline (prior to the intervention) and immediately after completion of the 3-day intervention period.
|
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
Time Frame: At baseline (prior to the intervention) and immediately after completion of the 3-day intervention period.
|
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
Time Frame: At baseline (prior to the intervention) and immediately after completion of the 3-day intervention period.
|
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.
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At baseline (prior to the intervention) and immediately after completion of the 3-day intervention period.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KBU-YTASDELEN-001
- E-77192459-050.99-331713 (Other Identifier: Karabuk University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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