The Effect of Distraction Methods Used During Inhalation... | NCT06510166

NCT06510166

Status Module

Oversight Module

Description Module

Detailed Description

In the literature, distraction techniques are generally used in invasive procedures. On the other hand, it is possible that studies on the effects of inhalation therapy and non-pharmacological methods, which are among the common non-invasive interventions in children, can still continue. Durak et al. (2021) stated that the developments in experimental groups, in which they were made to watch cartoons during inhalation treatment, were lower in adults than in control groups and in children. A similar study was published by Ozsamuri (2020), and children receiving mask and inhaler treatment consisted of watching cartoons, listening to music, and a control group. As a result of the study, intra-group comparisons show that the fear and anxiety scores of people in cartoon and music groups decreased compared to before the procedure . However, arranging emergency services for children and selling them with treatment materials have been shown to be effective in reducing children's fears. Negative reactions to the growth mask and nebulizer during inhaler therapy, causing incorrect inhalation patterns, and deterioration are reduced. Yanık and Ayyıldız (2019) conducted a study on the effectiveness of the training given with a toy-type nebulizer for children aged 3-6 years who received nebulizer therapy. During the therapy inhaler treatment, the scores of the people in the experimental group decreased, while the scores of the control group increased. Kırkan (2023) stated that the therapeutic play method applied with toy nebulizers and toy nebulizers in the activities he conducted with 3-8 year old children who received nebulizers is an effective method treatment in reducing fear and anxiety in the children's hospital. Distracting methods during inhaler treatment for children are beneficial for patients to have positive hospital experiences. This will reduce patients' fear of the hospital, prevent providers from experiencing stress, and ensure that people are satisfied. Adequate information during treatment procedures in children will improve fear, pain and anxiety management and increase the positive hospital experience. Rapid healing is important because of the reduced use of treatment materials, the effectiveness of human resources, and the increase in health knowledge.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
normal nebulizer + mask + distraction technique	Experimental	Inclusion criteria is below: Parent and child volunteer to participate in the study, The child is between 3-6 years old, Presentation due to upper and lower respiratory tract infection, Inhaler treatment will be applied with a nebulizer, No request for any other intravenous, intramuscular or invasive treatment, The child does not have any genetic, congenital, chronic or metabolic disease	Behavioral: Children's Fear and Anxiety normal nebulizer and mask+ distraction
toy type nebulizer + toy mask	Active Comparator	Inclusion criteria is below: Parent and child volunteer to participate in the study, The child is between 3-6 years old, Presentation due to upper and lower respiratory tract infection, Inhaler treatment will be applied with a nebulizer, No request for any other intravenous, intramuscular or invasive treatment, The child does not have any genetic, congenital, chronic or metabolic disease	Behavioral: Children's Fear and Anxiety a toy nebulizer and a toy mask
control group	No Intervention	Inclusion criteria is below: Parent and child volunteer to participate in the study, The child is between 3-6 years old, Presentation due to upper and lower respiratory tract infection, Inhaler treatment will be applied with a nebulizer, No request for any other intravenous, intramuscular or invasive treatment, The child does not have any genetic, congenital, chronic or metabolic disease

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Children's Fear and Anxiety normal nebulizer and mask+ distraction	Behavioral	Children in group 2 will receive their inhaler treatment with a normal nebulizer and mask, while at the same time one of the distraction techniques of their choice (drawing a picture, reading a story or watching an age-appropriate cartoon) will be applied.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changing the anxiety	Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.	'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'
changing the fear	Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.	'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Ondokuz Mayıs University		Samsun	Atakum	55139	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33742204	Background	Durak H, Uysal G. The Effect of Cartoon Watching and Distraction Card on Physiologic Parameters and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study. J Trop Pediatr. 2021 Jan 29;67(1):fmab018. doi: 10.1093/tropej/fmab018.
37940393	Background	Kirkan C, Kahraman A. Effect of therapeutic play using a toy nebulizer and toy mask on a child's fear and anxiety levels. J Pediatr Nurs. 2023 Nov-Dec;73:e556-e562. doi: 10.1016/j.pedn.2023.10.033. Epub 2023 Nov 7.

IPD Sharing Statement Module