Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
126 participants
INTERVENTIONAL
2025-09-01
2026-09-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The two different methods to be used will be designed to attract the attention and interest of the age groups of the children to be included in the research. In this way, it is thought that the child will focus his/her attention and curiosity on the two different methods to be used and the level of fear and anxiety will be affected during the inhalation treatment. This will increase the child's compliance and cooperation with the treatment and will encourage the child.
When the international and national literature was scanned, no study was found that investigated the effects of the two different distraction methods covered in the research during inhalation treatment. With the two different distraction methods to be used, inhalation treatment, which is a source of fear and anxiety for children, will become fun.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Inhalation Therapy on Children's Fear and Anxiety Levels and Physiological Parameters
NCT06486610
The Ventriloquist Puppet Method for Children Under The Inhaler Treatment
NCT06162598
The Effect of Distraction During Blood Collection on the Fear and Anxiety Levels of Children
NCT06476418
Effects of Active and Passive Distraction Methods on Children's Pain, Fear and Anxiety
NCT06826352
The Effect of Watching Informative Animation on Fear and Anxiety in Children
NCT05861232
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Movable and 3D book: Movable and 3D book that will be suitable and specially designed for inhalation therapy will be used. The book will include materials that children frequently encounter in inhalation therapy (mask, nebulizer, drug models used for treatment, a model of the nurse administering the treatment, and a model of the environment where inhalation therapy is performed). The book is aimed to attract children's attention by being made in an animated and three-dimensional form. The prepared book is presented to the opinions of experts in the field of child health and improvements will be made in line with the feedback. The final version of the book, which is specially designed and suitable for inhalation therapy, will be converted into two different formats and made ready for use in research. The aim of preparing it in two formats is to increase the child's interest in the book by giving him the right to choose. It is thought that this innovative book will have significant effects on children's fear and anxiety levels.
Hand Puppet: A hand puppet that is specially designed for inhalation therapy will be used. Hand puppets that aim to make inhalation therapy fun will be prepared (by playing with children the situations of different characters receiving inhalation therapy in the form of a game). The hand puppets that will be designed with the researcher, preschool teacher and child development specialist who receive play therapy will be prepared in a hypoallergenic form. In order to provide children with the right to choose, different forms will be prepared and children's ideas will be given importance. It is thought that the hand puppet that is specially designed for inhalation therapy will have significant effects on children's fear and anxiety levels.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Moving and 3D Book Group
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled. During the inhaler treatment, the researcher will ensure that the child spends time with a moving and 3D book that will be specially designed and suitable for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes.
Moving and 3D Book
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled out. During the inhaler treatment, the child will spend time with a moving and 3D book that will be specially designed for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled out again. Filling out the forms will take an average of 5-10 minutes.
Hand Puppet Group
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and parent will be introduced and the purpose of the study will be explained and the scales will be filled. During the inhaler treatment, the researcher will ensure that the child spends time with a hand puppet that will be specially designed and suitable for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes.
Hand Puppet
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled out. During the inhaler treatment, the child will spend time with a hand puppet that will be specially designed for inhalation treatment by the researcher. After the treatment is completed.
Control Group
The data collector will be taken to the environment where the child will receive inhalation treatment and the routine procedures will be continued. Then, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Moving and 3D Book
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled out. During the inhaler treatment, the child will spend time with a moving and 3D book that will be specially designed for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled out again. Filling out the forms will take an average of 5-10 minutes.
Hand Puppet
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled out. During the inhaler treatment, the child will spend time with a hand puppet that will be specially designed for inhalation treatment by the researcher. After the treatment is completed.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Not having a developmental disability
* Not having a history of sedative, analgesic or narcotic substance use within 24 hours before application
* Receiving inhalation therapy for the first time
* Not having a chronic disease
* Children who are accompanied by their mother or father during the procedure will be included in the study.
Exclusion Criteria
* having a chronic disease
4 Years
6 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ataturk University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
ARZU SARIALİOĞLU
Associate professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ataturk University Nursing of Faculty
Erzurum, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B.30.2.ATA.0.01.00/136
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.