Childsocial robotsNCT07056816
Effects of Interactive Toys and Robots on Anxiety and Fear in Children Receiving Nebulized Inhalation in the Pediatric Emergency Department
A study testing Interactive Doll and Interactive Robot in people with Child and Fear Anxiety, run by Aylin Kurt at 1 site in Turkey (Türkiye).
Trial summary
Pediatric emergency services are of critical importance for pediatric patients admitted due to sudden illnesses and traumas. However, these environments are serious sources of stress and anxiety for children due to reasons such as uncertainty, pain, and separation anxiety. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Child, Fear Anxiety, Inhalant Use
- What is being tested?
- Interactive Doll and Interactive Robot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2025to 8 Sep 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being a child between the ages of 4-10,
- Receiving nebulized inhalation treatment in the pediatric emergency department,
- The parent agreeing to participate in the research,
- The child not having speech or vision impairments or any other disabilities that would hinder or prevent communication.
Who cannot join
- Children whose parents' permission cannot be obtained
- The child's speech and vision impairment, or any other disability that would make communication difficult or prevent it.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Çocuk Acil Serviste Nebülize İnhalasyon Alan Çocuklarda İnteraktif Oyuncak ve Robot'un Anksiyete ve Korkuya Etkisi: Randomize Kontrollü Çalışma
Pediatric emergency services are of critical importance for pediatric patients admitted due to sudden illnesses and traumas. However, these environments are serious sources of stress and anxiety for children due to reasons such as uncertainty, pain, and separation anxiety. The emergency service experience can have long-term effects on the child's psychological state and negatively affect the success of medical interventions. Therefore, the development and implementation of various methods to reduce children's anxiety has become a great necessity. In recent years, interactive toys and robotic systems have been increasingly used in medical settings to reduce children's anxiety. Such technological tools have been shown to provide emotional support to children, reduce stress levels by distracting them, and make medical procedures more tolerable. However, there is not enough evidence-based research on the effectiveness of interactive toys and robots, especially in emergency settings, during common but frightening procedures such as nebulized inhalation. This study aims to evaluate the effect of interactive toys and robots on anxiety and fear in children receiving nebulized inhalation treatment in pediatric emergency services. This study, which will be conducted using a randomized controlled design, will make a significant contribution to understanding and improving children's psychological responses to medical procedures. The study was planned as a randomized controlled trial. The population of this study will be conducted in the pediatric emergency department of Ankara Provincial Health Directorate Yıldırım Beyazıt University Yenimahalle Education and Research Hospital between 05.05.2025-05.05.2026. The sample of this study will consist of 72 children aged between 4-10 who agreed to participate in the study and met the inclusion criteria and who received nebulized inhalation treatment and met the inclusion criteria.
Hypotheses of the study:
Read more
H0 = Playing with interactive toys and interactive robots during nebulized inhalation treatment has no effect on anxiety and fear in children.
H1 = Playing with interactive toys and interactive robots during nebulized inhalation treatment is effective in reducing anxiety and fear in children.
- Conditions
- Child, Fear Anxiety, Inhalant Use
- Being tested
- Interactive Doll, Interactive Robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive DollOther
Interactive Doll: Their hearts beat and they say "hello" as soon as you put it on your finger because they know it's really yours! They also have a different personality and reactions when they open and close your finger. With sensors in their head, mouth and belly, Fingerlings respond to your touch and will respond to you. You can also shake them and turn them upside down for even more reactions because they love to monkey around. And their positive tail can hang down or flip up so they can sit on your table or shelf. Kids will play with the Interactive Doll during the inhalation treatment.
Interactive RobotOther
Interactive Robot: It has an interactive design that improves children's music listening and learning skills. It attracts children's attention with its vibrant colors and cute design, and teaches them while having fun. It has a voice imitation feature and a response feature that makes different sounds when its head is touched. Children will play with the Interactive Robot during inhalation treatment.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Doll Group | Experimental | Interactive Doll: Their hearts beat and they say "hello" as soon as you put it on your finger because they know it's really yours! They also have a different personality and reactions when they open and close your finger. With sensors in their head, mouth and belly, Fingerlings respond to your touch and will respond to you. You can also shake them and turn them upside down for even more reactions because they love to monkey around. And their positive tail can hang down or flip up so they can sit on your table or shelf. Kids will play with the Interactive Doll during the inhalation treatment. Receives: Other: Interactive Doll |
| Interactive Robot Group | Experimental | Interactive Robot: It has an interactive design that improves children's music listening and learning skills. It attracts children's attention with its vibrant colors and cute design, and teaches them while having fun. It has a voice imitation feature and a response feature that makes different sounds when its head is touched. Children will play with the Interactive Robot during inhalation treatment. Receives: Other: Interactive Robot |
| Control Group | No intervention | The standard information given to all children receiving nebulized inhalation treatment in the pediatric emergency department will be given to the children in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of anxiety is evaluated using the Children Anxiety Meter-State
The Children's Anxiety Meter (CAM-S) assesses children's anxiety in clinical settings and is used prior to medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom and contains horizontal lines at intervals going upwards. Scale scores range from 0 to 10, where higher values represent higher anxiety. Personal reports and records from children, their parents, the researcher, and the nurse, who are asked to mark the scale with a pen, are used to assess the anxiety levels of children
Measured: during the procedure
Secondary outcomes (1)
The level of anxiety is evaluated using the Child Fear Scale
Child Fear Scale assesses children's fear in clinical settings and is used prior to medical procedures. The Child Fear Scale (CFS) consists of facial expressions ranging from a neutral face on the far left (0 points: no fear/anxiety) to a frightened face on the far right (4 points: extreme fear/anxiety). Children are asked to mark their level of fear or anxiety by choosing the most appropriate facial expression to represent them. Personal reports and records from children, their parents, the researcher, and the nurse, who are asked to mark the scale with a pen, are used to assess the anxiety levels of children.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start30 Jun 2025
- Primary completion1 Jul 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aylin Kurt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aylin Kurt, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056816
- Sponsor's protocol ID
- 2025-SBB-0315
- Acronym
- social robots
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Çocuk Acil Serviste Nebülize İnhalasyon Alan Çocuklarda İnteraktif Oyuncak ve Robot'un Anksiyete ve Korkuya Etkisi: Randomize Kontrollü Çalışma
- ClinicalTrials.gov ID
- NCT07056816
- Acronym / sponsor ID
- social robots / 2025-SBB-0315
- Conditions
- Child, Fear Anxiety, Inhalant Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Aylin KurtUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 9 Jul 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.
Pediatric emergency services are of critical importance for pediatric patients admitted due to sudden illnesses and traumas. However, these environments are serious sources of stress and anxiety for children due to reasons such as uncertainty, pain, and separation anxiety. The emergency service experience can have long-term effects on the child's psychological state and negatively affect the success of medical interventions. Therefore, the development and implementation of various methods to reduce children's anxiety has become a great necessity. In recent years, interactive toys and robotic systems have been increasingly used in medical settings to reduce children's anxiety. Such technological tools have been shown to provide emotional support to children, reduce stress levels by distracting them, and make medical procedures more tolerable. However, there is not enough evidence-based research on the effectiveness of interactive toys and robots, especially in emergency settings, during common but frightening procedures such as nebulized inhalation. This study aims to evaluate the effect of interactive toys and robots on anxiety and fear in children receiving nebulized inhalation treatment in pediatric emergency services. This study, which will be conducted using a randomized controlled design, will make a significant contribution to understanding and improving children's psychological responses to medical procedures. The study was planned as a randomized controlled trial. The population of this study will be conducted in the pediatric emergency department of Ankara Provincial Health Directorate Yıldırım Beyazıt University Yenimahalle Education and Research Hospital between 05.05.2025-05.05.2026. The sample of this study will consist of 72 children aged between 4-10 who agreed to participate in the study and met the inclusion criteria and who received nebulized inhalation treatment and met the inclusion criteria.
Hypotheses of the study:
H0 = Playing with interactive toys and interactive robots during nebulized inhalation treatment has no effect on anxiety and fear in children.
H1 = Playing with interactive toys and interactive robots during nebulized inhalation treatment is effective in reducing anxiety and fear in children.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interactive Doll Group | Experimental | Other: Interactive DollInteractive Doll: Their hearts beat and they say "hello" as soon as you put it on your finger because they know it's really yours! They also have a different personality and reactions when they open and close your finger. With sensors in their head, mouth and belly, Fingerlings respond to your touch and will respond to you. You can also shake them and turn them upside down for even more reactions because they love to monkey around. And their positive tail can hang down or flip up so they can sit on your table or shelf. Kids will play with the Interactive Doll during the inhalation treatment. |
| Interactive Robot Group | Experimental | Other: Interactive RobotInteractive Robot: It has an interactive design that improves children's music listening and learning skills. It attracts children's attention with its vibrant colors and cute design, and teaches them while having fun. It has a voice imitation feature and a response feature that makes different sounds when its head is touched. Children will play with the Interactive Robot during inhalation treatment. |
| Control Group | No intervention | –The standard information given to all children receiving nebulized inhalation treatment in the pediatric emergency department will be given to the children in the control group. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being a child between the ages of 4-10,
- Receiving nebulized inhalation treatment in the pediatric emergency department,
- The parent agreeing to participate in the research,
- The child not having speech or vision impairments or any other disabilities that would hinder or prevent communication.
Key exclusion criteria (2 listed)
- Children whose parents' permission cannot be obtained
- The child's speech and vision impairment, or any other disability that would make communication difficult or prevent it.
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 |
|---|---|---|
| Interactive DollInteractive Doll: Their hearts beat and they say "hello" as soon as you put it on your finger because they know it's really yours! They also have a different personality and reactions when they open and close your finger. With sensors in their head, mouth and belly, Fingerlings respond to your touch and will respond to you. You can also shake them and turn them upside down for even more reactions because they love to monkey around. And their positive tail can hang down or flip up so they can sit on your table or shelf. Kids will play with the Interactive Doll during the inhalation treatment. | Other | Interactive Doll Group |
| Interactive RobotInteractive Robot: It has an interactive design that improves children's music listening and learning skills. It attracts children's attention with its vibrant colors and cute design, and teaches them while having fun. It has a voice imitation feature and a response feature that makes different sounds when its head is touched. Children will play with the Interactive Robot during inhalation treatment. | Other | Interactive Robot Group |
Primary outcome
The level of anxiety is evaluated using the Children Anxiety Meter-State
Time frame: during the procedure
The Children's Anxiety Meter (CAM-S) assesses children's anxiety in clinical settings and is used prior to medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom and contains horizontal lines at intervals going upwards. Scale scores range from 0 to 10, where higher values represent higher anxiety. Personal reports and records from children, their parents, the researcher, and the nurse, who are asked to mark the scale with a pen, are used to assess the anxiety levels of children
1 secondary outcome
The level of anxiety is evaluated using the Child Fear Scale
Time frame: during the procedure
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 17 Dec 2025.
- Individual participant dataSharing planned: Yes
Related trials for Child
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
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 Interactive Doll and Interactive Robot in people with Child and Fear Anxiety, run by Aylin Kurt 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 4 inclusion and 2 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 17 Dec 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?
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 level of anxiety is evaluated using the Children Anxiety Meter-State (time frame: during the procedure). 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 Dec 2025.