Hospitalization in ChildrenNCT06763263
Effect of Superhero Clothing and Figure on Hospital Adjustment in Children During Hospitalization
A study testing Experimental in people with Hospitalization in Children, run by Nisa Meriç Turan at 1 site in Turkey (Türkiye).
Trial summary
Healthcare professionals and administrators who serve children are aware of the role of play in children's lives and with this awareness, they design playrooms and areas for children in hospitals. Read more about this study
- Who is it for?
- Ages 24 to 36 months
- Conditions the study is for
- Hospitalization in Children
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 24 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child's age range is between 24-36 months
- On the first day of the child's hospitalization
- The child is hospitalized with an acute problem
- It is the child's first hospitalization
- The child will probably stay in the hospital for at least three days.
- Parent's ability to read and write Turkish
- Parent must be over 18 years of age
- Parent's consent to participate in the research
Who cannot join
- The child has a mental health problem
- The child receives daily outpatient treatment at the hospital
- Children hospitalized with their siblings
- The parent has a known psychiatric problem
- Parent has communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Superhero Clothing and Figure on Hospital Adjustment in Children During Hospitalization: Randomized Controlled Study
Healthcare professionals and administrators who serve children are aware of the role of play in children's lives and with this awareness, they design playrooms and areas for children in hospitals. Nurses who consider play as an important atraumatic care approach that supports the child's development, reduces stress and anxiety, and thus contributes to the improvement of hospital compliance have conducted some studies on this subject. Sarman (2022) found in his study that animal-assisted treatment with aquarium fish in the hospital for children aged 8-10 was effective in reducing children's fear and anxiety, strengthening positive emotions, ensuring that the hospital environment was accepted as safe, reducing the feeling of loneliness and facilitating adaptation to the hospital. In another study, play and art therapy was applied to hospitalized children between the ages of 2 and 4, and it was determined that play therapy was more effective in reducing children's anxiety than art therapy and the control group. In their study evaluating the effect of the "hospital friend, Yarencik" initiative on the hospital adaptation of children aged 1-3, Özcan and Güdücü Tüfekci (2022) found that the hospital adaptation of the intervention group after the application was significantly higher than the control group. Although the above studies show that studies using developmentally appropriate and attractive methods to increase the compliance of young children to hospitalization are effective, the number of methods and studies tested is limited. Finding the best method to increase the compliance of young children to hospital and providing evidence that will form the basis for the development and updating of guides or guides is an important requirement.
Read the detailed description
Illness and hospitalization are processes that cause negative experiences for the child and the family and that worry and disturb the parents. The number of children affected by chronic diseases or illnesses suffered in the last 6 months in Turkey in 2022 was determined as 6.5%. The illness and hospitalization process affects both the child and the family. In the hospital environment, children can experience many negative emotions such as anxiety, stress, fear, communication problems, anger, regression, hopelessness. Young children, especially those hospitalized, experience adverse psychosocial symptoms. Factors such as the child's gender, age, developmental level, emotional state, parents' level of education and reaction to the disease, level of communication within the family, the child being separated from home or loved ones, whether the disease is acute or chronic, the treatment and adaptation process, feeling pain/suffering, experiencing organ or function loss can affect the child's adaptation to the hospital. Young children may not understand the explanations given about their illness due to their developmental level. Children may experience adaptation problems in the hospital environment with reactions such as fear, anxiety, anger, rage, and thumb sucking.
Parents may also experience psychological or social problems even after their children are hospitalized or discharged. In a study conducted by Açıkgöz et al. (2019) with mothers of 100 hospitalized children diagnosed with acute illness and 100 with chronic illness, 36% of mothers of children with acute illness and 21% of mothers of children with chronic illness had severe depressive symptoms. In the same study, 95% of mothers of children with acute illness had high state anxiety levels, 87% had high trait anxiety levels, and 87% of mothers of children with chronic illness had high state anxiety levels and 69% had high trait anxiety levels. In a study conducted with 118 mothers and fathers whose children were in intensive care, it was found that 24% of the parents had severe anxiety, 51% had major depression and 26% had decisional conflict. The emotions experienced by children, their ability to cope with and adapt to them, and the duration, severity or intensity of the disease affect mothers' concerns.
One of the most important factors that increase the stress or anxiety level of children and families and make adaptation difficult is the traumatizing effect of the child's hospitalization and the events experienced in the hospital environment. In order to reduce these traumatic effects, pediatric nurses apply atraumatic care. Atraumatic care practices include a series of nursing interventions that ensure the active participation of the child and family in care, provision of emotional support, coping with stress, and reduction of pain. Positive experiences during the child's hospitalization period thanks to atraumatic care practices positively affect the child and the family. In this context, many interventions can be made to ensure the child's adaptation to the hospital, such as various games, toys, books, cartoons, videos, family and friend visits, reading books, chatting, writing letters, music activities, painting, theater and clown shows, computer activities, introduction activities and various forms of educational activities, depending on the child's age and development level.
Healthcare professionals and administrators who serve children are aware of the role of play in children's lives and with this awareness, they design playrooms and areas for children in hospitals. Nurses who consider play as an important atraumatic care approach that supports the child's development, reduces stress and anxiety, and thus contributes to the improvement of hospital compliance have conducted some studies on this subject. Sarman (2022) found in his study that animal-assisted treatment with aquarium fish in the hospital for children aged 8-10 was effective in reducing children's fear and anxiety, strengthening positive emotions, ensuring that the hospital environment was accepted as safe, reducing the feeling of loneliness and facilitating adaptation to the hospital. In another study, play and art therapy was applied to hospitalized children between the ages of 2 and 4, and it was determined that play therapy was more effective in reducing children's anxiety than art therapy and the control group. In their study evaluating the effect of the "hospital friend, Yarencik" initiative on the hospital adaptation of children aged 1-3, Özcan and Güdücü Tüfekci (2022) found that the hospital adaptation of the intervention group after the application was significantly higher than the control group. Although the above studies show that studies using developmentally appropriate and attractive methods to increase the compliance of young children to hospitalization are effective, the number of methods and studies tested is limited. Finding the best method to increase the compliance of young children to hospital and providing evidence that will form the basis for the development and updating of guides or guides is an important requirement.
- Conditions
- Hospitalization in Children
- Being tested
- Experimental, Control
- Keywords
- Hospitalization in children, Child, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
Children and their parents in this group will be informed about the research and their verbal and written consent will be obtained. A questionnaire will be filled out before the application. Then, the child will be allowed to choose one of the superhero clothes he/she wants in his/her room and will be allowed to wear the clothes. The superhero figure will be shown to him/her and he/she will be allowed to play with the clothes and the figure for 2 hours.
ControlBehavioural
The children in this group and their parents will be informed about the research and their verbal and written consent will be obtained. A questionnaire will be filled out before the application. The children will be evaluated in terms of their reactions after their hospitalization, they will not be dressed in any clothing and no superhero figures will be used. Then the questionnaire will be filled out again and scoring will be done. In order to prevent ethical bias before discharge, the child will be dressed in a superhero costume and will be allowed to spend time with the clothing and figure.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Superhero Clothing and Figure Group | Experimental | Superhero Clothing and Figure Group Receives: Behavioral: Experimental |
| Active:Control | Active comparator | Control Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic Questionnaire
This form was prepared by researchers in line with the literature in order to determine the sociodemographic characteristics of the children and to learn their thoughts about the hospital It consists of 14 questions that include the sociodemographic characteristics of the child and the family and information about the hospital.
Measured: During the children's first hospitalization, the researcher will fill out Sociodemographic Questionnaire ( Approximately 10 minute).
Children's Hospital Adaptation Evaluation Scale (CHILD-HÜDO)
The scale, developed in Turkey to evaluate the hospitalization of mothers' 1-3 year old children, is a 5-point Likert-type scale (1-Continuous, 2- Frequently, 3- Occasionally, 4- Very little, 5- Never). It was prepared for children aged 1-3 who are hospitalized. The Scale for Evaluating Children's Hospital Adaptation consists of 22 items and a single dimension. The scale was developed by Özcan and Güdücü Tüfekci by 2022. The lowest score that can be obtained from the scale is 22, and the highest score is 110. As the score obtained from the scale increases, the children's adaptation to the hospital increases. There is no reverse-scored item in the scale. Cronbach's alpha was determined as 0.818 for the entire scale.
Measured: It will be filled out by the researcher and parent before and after the procedure (Approximately 10 minute).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start30 Dec 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalization in 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
- Model description
- The study was planned as a pre-test, post-test parallel group (invertion-control), randomized controlled experimental research type.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nisa Meriç Turan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nisa Meriç Turan, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763263
- Sponsor's protocol ID
- NEUTEZYL2024
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Superhero Clothing and Figure on Hospital Adjustment in Children During Hospitalization: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06763263
- Acronym / sponsor ID
- NEUTEZYL2024
- Conditions
- Hospitalization in Children
- Keywords
- Hospitalization in children, Child, Nursing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Nisa Meriç TuranUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Jan 2025 (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.
Healthcare professionals and administrators who serve children are aware of the role of play in children's lives and with this awareness, they design playrooms and areas for children in hospitals. Nurses who consider play as an important atraumatic care approach that supports the child's development, reduces stress and anxiety, and thus contributes to the improvement of hospital compliance have conducted some studies on this subject. Sarman (2022) found in his study that animal-assisted treatment with aquarium fish in the hospital for children aged 8-10 was effective in reducing children's fear and anxiety, strengthening positive emotions, ensuring that the hospital environment was accepted as safe, reducing the feeling of loneliness and facilitating adaptation to the hospital. In another study, play and art therapy was applied to hospitalized children between the ages of 2 and 4, and it was determined that play therapy was more effective in reducing children's anxiety than art therapy and the control group. In their study evaluating the effect of the "hospital friend, Yarencik" initiative on the hospital adaptation of children aged 1-3, Özcan and Güdücü Tüfekci (2022) found that the hospital adaptation of the intervention group after the application was significantly higher than the control group. Although the above studies show that studies using developmentally appropriate and attractive methods to increase the compliance of young children to hospitalization are effective, the number of methods and studies tested is limited. Finding the best method to increase the compliance of young children to hospital and providing evidence that will form the basis for the development and updating of guides or guides is an important requirement.
Detailed description
Illness and hospitalization are processes that cause negative experiences for the child and the family and that worry and disturb the parents. The number of children affected by chronic diseases or illnesses suffered in the last 6 months in Turkey in 2022 was determined as 6.5%. The illness and hospitalization process affects both the child and the family. In the hospital environment, children can experience many negative emotions such as anxiety, stress, fear, communication problems, anger, regression, hopelessness. Young children, especially those hospitalized, experience adverse psychosocial symptoms. Factors such as the child's gender, age, developmental level, emotional state, parents' level of education and reaction to the disease, level of communication within the family, the child being separated from home or loved ones, whether the disease is acute or chronic, the treatment and adaptation process, feeling pain/suffering, experiencing organ or function loss can affect the child's adaptation to the hospital. Young children may not understand the explanations given about their illness due to their developmental level. Children may experience adaptation problems in the hospital environment with reactions such as fear, anxiety, anger, rage, and thumb sucking.
Parents may also experience psychological or social problems even after their children are hospitalized or discharged. In a study conducted by Açıkgöz et al. (2019) with mothers of 100 hospitalized children diagnosed with acute illness and 100 with chronic illness, 36% of mothers of children with acute illness and 21% of mothers of children with chronic illness had severe depressive symptoms. In the same study, 95% of mothers of children with acute illness had high state anxiety levels, 87% had high trait anxiety levels, and 87% of mothers of children with chronic illness had high state anxiety levels and 69% had high trait anxiety levels. In a study conducted with 118 mothers and fathers whose children were in intensive care, it was found that 24% of the parents had severe anxiety, 51% had major depression and 26% had decisional conflict. The emotions experienced by children, their ability to cope with and adapt to them, and the duration, severity or intensity of the disease affect mothers' concerns.
One of the most important factors that increase the stress or anxiety level of children and families and make adaptation difficult is the traumatizing effect of the child's hospitalization and the events experienced in the hospital environment. In order to reduce these traumatic effects, pediatric nurses apply atraumatic care. Atraumatic care practices include a series of nursing interventions that ensure the active participation of the child and family in care, provision of emotional support, coping with stress, and reduction of pain. Positive experiences during the child's hospitalization period thanks to atraumatic care practices positively affect the child and the family. In this context, many interventions can be made to ensure the child's adaptation to the hospital, such as various games, toys, books, cartoons, videos, family and friend visits, reading books, chatting, writing letters, music activities, painting, theater and clown shows, computer activities, introduction activities and various forms of educational activities, depending on the child's age and development level.
Healthcare professionals and administrators who serve children are aware of the role of play in children's lives and with this awareness, they design playrooms and areas for children in hospitals. Nurses who consider play as an important atraumatic care approach that supports the child's development, reduces stress and anxiety, and thus contributes to the improvement of hospital compliance have conducted some studies on this subject. Sarman (2022) found in his study that animal-assisted treatment with aquarium fish in the hospital for children aged 8-10 was effective in reducing children's fear and anxiety, strengthening positive emotions, ensuring that the hospital environment was accepted as safe, reducing the feeling of loneliness and facilitating adaptation to the hospital. In another study, play and art therapy was applied to hospitalized children between the ages of 2 and 4, and it was determined that play therapy was more effective in reducing children's anxiety than art therapy and the control group. In their study evaluating the effect of the "hospital friend, Yarencik" initiative on the hospital adaptation of children aged 1-3, Özcan and Güdücü Tüfekci (2022) found that the hospital adaptation of the intervention group after the application was significantly higher than the control group. Although the above studies show that studies using developmentally appropriate and attractive methods to increase the compliance of young children to hospitalization are effective, the number of methods and studies tested is limited. Finding the best method to increase the compliance of young children to hospital and providing evidence that will form the basis for the development and updating of guides or guides is an important requirement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as a pre-test, post-test parallel group (invertion-control), randomized controlled experimental research type.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Superhero Clothing and Figure Group | Experimental | Behavioral: ExperimentalSuperhero Clothing and Figure Group |
| Active:Control | Active comparator | Behavioral: ControlControl |
Who may qualify
- Ages
- 24 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The child's age range is between 24-36 months
- On the first day of the child's hospitalization
- The child is hospitalized with an acute problem
- It is the child's first hospitalization
- The child will probably stay in the hospital for at least three days.
Key exclusion criteria (5 listed)
- The child has a mental health problem
- The child receives daily outpatient treatment at the hospital
- Children hospitalized with their siblings
- The parent has a known psychiatric problem
- Parent has communication problems
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 |
|---|---|---|
| ExperimentalChildren and their parents in this group will be informed about the research and their verbal and written consent will be obtained. A questionnaire will be filled out before the application. Then, the child will be allowed to choose one of the superhero clothes he/she wants in his/her room and will be allowed to wear the clothes. The superhero figure will be shown to him/her and he/she will be allowed to play with the clothes and the figure for 2 hours. | Behavioural | Experimental: Superhero Clothing and Figure Group |
| ControlThe children in this group and their parents will be informed about the research and their verbal and written consent will be obtained. A questionnaire will be filled out before the application. The children will be evaluated in terms of their reactions after their hospitalization, they will not be dressed in any clothing and no superhero figures will be used. Then the questionnaire will be filled out again and scoring will be done. In order to prevent ethical bias before discharge, the child will be dressed in a superhero costume and will be allowed to spend time with the clothing and figure. | Behavioural | Active:Control |
Primary outcome
Sociodemographic Questionnaire
Time frame: During the children's first hospitalization, the researcher will fill out Sociodemographic Questionnaire ( Approximately 10 minute).
This form was prepared by researchers in line with the literature in order to determine the sociodemographic characteristics of the children and to learn their thoughts about the hospital It consists of 14 questions that include the sociodemographic characteristics of the child and the family and information about the hospital.
Children's Hospital Adaptation Evaluation Scale (CHILD-HÜDO)
Time frame: It will be filled out by the researcher and parent before and after the procedure (Approximately 10 minute).
The scale, developed in Turkey to evaluate the hospitalization of mothers' 1-3 year old children, is a 5-point Likert-type scale (1-Continuous, 2- Frequently, 3- Occasionally, 4- Very little, 5- Never). It was prepared for children aged 1-3 who are hospitalized. The Scale for Evaluating Children's Hospital Adaptation consists of 22 items and a single dimension. The scale was developed by Özcan and Güdücü Tüfekci by 2022. The lowest score that can be obtained from the scale is 22, and the highest score is 110. As the score obtained from the scale increases, the children's adaptation to the hospital increases. There is no reverse-scored item in the scale. Cronbach's alpha was determined as 0.818 for the entire scale.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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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 Experimental in people with Hospitalization in Children, run by Nisa Meriç Turan 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 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sociodemographic Questionnaire (time frame: During the children's first hospitalization, the researcher will fill out Sociodemographic Questionnaire ( Approximately 10 minute).). The study lists 2 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 17 Jan 2025.