Hospitalized ChildrenTHERASTORYNCT07418515
Impact of Therapeutic Storytelling on Fear, Screen Time, and Parental Stress Among Hospitalized Children
A study testing Therapeutic Story Telling and routine care in people with Hospitalized Children and Parent Stress, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Hospitalized Children, Parent Stress
- What is being tested?
- Therapeutic Story Telling and routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 4 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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).
- Conditions
- Hospitalized Children, Parent Stress
- Being tested
- Therapeutic Story Telling, routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Story TellingBehavioural
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).
routine careOther
Participants in the routine care arm received routine pediatric ward care without therapeutic story reading sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Therapeutic Story Telling |
| Routine care group | Other | Participants in the routine care arm received routine pediatric ward care without therapeutic story reading sessions. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline (prior to the intervention) and immediately after completion of the 3-day intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jun 2024
- Primary completion1 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Taşdelen, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418515
- Sponsor's protocol ID
- KBU-YTASDELEN-001
- Other IDs
- E-77192459-050.99-331713
- Acronym
- THERASTORY
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Therapeutic Storytelling on Fear, Screen Time, and Parental Stress Among Hospitalized Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07418515
- Acronym / sponsor ID
- THERASTORY / KBU-YTASDELEN-001
- Conditions
- Hospitalized Children, Parent Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Storytelling group | Experimental | Behavioral: Therapeutic Story TellingParticipants 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. |
| Routine care group | Other | Other: routine careParticipants in the routine care arm received routine pediatric ward care without therapeutic story reading sessions. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Story TellingThe 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). | Behavioural | Storytelling group |
| routine careParticipants in the routine care arm received routine pediatric ward care without therapeutic story reading sessions. | Other | Routine care group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Story Telling and routine care in people with Hospitalized Children and Parent Stress, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.