Clinical trial NCT06510166: The Effect of Distraction Methods Used During Inhalation Therapy on Children's Fear and Anxiety
Official title: The Effect of Distraction Methods Used During Inhalation Therapy on Children's Fear and Anxiety: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child
Inhalation Therapy; Complications
Fear
Distraction Methods
Anxiety
Keywords: child
inhalation theraphy
fear
distraction methods
anxiety
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was aimed to examine the effects of distraction methods used during inhalation therapy on children's fear and anxiety.

Hypothesis:

Hypothesis 0 (H0): There is no difference between the fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques and toy type nebulizer + toy mask during inhaler treatment and the children in the control group.

Hypothesis 1 (H1): The fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques during inhaler treatment are lower than the children in the control group.

Hypothesis 2 (H2): The fear and anxiety levels of children who were applied a toy type nebulizer + toy mask during inhaler treatment are lower than the children in the control group.

Hypothesis 3 (H3): The fear and anxiety levels of children who were treated with a toy type nebulizer + toy mask during inhaler treatment were lower than those of children who were treated with a normal nebulizer + mask + distraction techniques.

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.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* Parent and child are not willing to participate in the study,
* The child is not between 3-6 years old,
* Presentation for a reason other than upper and lower respiratory tract infection,
* No inhaler treatment with a nebulizer,
* Request for any other intravenous, intramuscular or invasive treatment,
* The child has any genetic, congenital, chronic or metabolic disease

Primary outcomes:
measure: changing the anxiety
timeFrame: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'
measure: changing the fear
timeFrame: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
state: Atakum
Study officials:
References:
citation: 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.
citation: 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.