Clinical trial NCT06755918: Video Games and Mask Painting on During Nebulizer Application in Children
Official title: Effect of Video Games and Mask Painting on Anxiety and Treatment Compliance During Nebulizer Application in Children: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: NEBULIZATION
Children
Keywords: Nebulizer
Child
Anxiety
Treatment Compliance
Nursing
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 66
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is a randomized controlled experimental study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The clinical features of respiratory system diseases seen in childhood are generally moderate and improve in a short time. Respiratory system diseases are divided into two as upper respiratory system diseases and lower respiratory system diseases. The respiratory tract, from the mouth and nose, which are the upper respiratory tract, to the glottis (nasal mucosa, nasopharynx, oropharynx, sinuses, middle ear tonsils and epiglottis) and the infections that occur in these sections are called upper respiratory tract infections (URTI). Lower respiratory system diseases are considered as tuberculosis, asthma, cystic fibrosis and bronchopulmonary dysplasia. The most common diseases in children are respiratory tract diseases. The diseases that are considered as priorities for each age group vary. According to the Turkish Thoracic Society, the incidence of lower respiratory tract infections (LRTI) between the ages of 0-5 is 29%. According to TUIK 2022 data, upper respiratory tract infections are the most common infectious diseases experienced by children between the ages of 0-6 with a rate of 31.3%, and lower respiratory tract infections are the third with a rate of 6.9%. In children between the ages of 7-14, upper respiratory tract infections are the most common with a rate of 27.1%, and lower respiratory tract infections are the third with a rate of 5.3%.

Detailed description: The treatment of respiratory system diseases includes maintaining airway patency, using antibiotics and corticosteroids, and oxygen support. The most preferred is bronchodilator - vasoconstriction and bronchodilation (nebule therapy). Nebulizer use reduces symptoms by reducing wheezing, shortness of breath, and edema in the respiratory tract, and therapeutics (saline fluids, bronchodilators, epinephrine, anticholinergic agents, and corticosteroids) used are used as a treatment option. The use of nebulizer drugs is used as an emergency treatment method in both children and adults, especially in respiratory system diseases, all over the world and in Turkey. In addition, their use in the treatment of lung diseases is increasing. The main purpose of inhalation treatment is to send smaller amounts of medication directly to the respiratory tract as soon as possible, to deliver drug particles to the farthest lobes of the lungs, to eliminate airway stenosis in the respiratory system and to regulate the amount of mucus.

In children, the process of hospitalization, treatment, and the devices used can be traumatic. Many devices used in the hospital, such as the use of nebulizers, the sounds of the devices, unfamiliar people, unfamiliar environments, dependence on caregivers, unfamiliar tools and equipment, traumatic and painful invasive procedures, separation from family and friends, disruption of routines such as sleep, eating, playing, and school can affect children's anxiety levels and compliance with treatment. The pain and suffering they experience during procedures can be reduced by using distraction methods. One of the distraction methods is therapeutic play. Therapeutic play should be used as an effective method to minimize the negative effects of procedures and to support the child in developing effective coping methods. It has been observed in literature studies that children who use nebulizers together with therapeutic play have decreased fear, pain, anxiety and stress levels. In the study conducted by Kırkan et al. (2023), it was observed that nebulizer treatment with a toy nebulizer and a toy mask decreased children's anxiety levels. In another study conducted by Kurtuncu et al. (2019), it was observed that 3-dimensional nebulizer treatment reduced psychosocial symptoms seen in children. In another study, it was determined that education given with a toy-type nebulizer reduced anxiety levels in children. Therapeutic play allows effective cooperation with the child by understanding the child's behavior. Therapeutic play has an important measure in ensuring that children comply with treatment, display positive behavior, and improve care. This study, which can be easily applied by nurses in the hospital environment before, during, and after medical, invasive procedures, will also ensure children's compliance with treatment and is thought to contribute to the literature; will be conducted to examine the effects of video games and mask painting on anxiety and treatment compliance during nebulizer application in children.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 7-12
* Receiving the first nebulization treatment after hospitalization
* Able to speak and read Turkish
* Receiving nebulizer treatment
* Children who agree to participate in the study and children whose parents agree to participate in the study

Exclusion Criteria:

* Those who are allergic to paint
* Those who have a chronic disease and routinely use a nebulizer
* Those who are connected to any respiratory device (mechanical, etc.)
* Those who did not complete the intervention and wish to withdraw from the study
* Those who have any body function deficiency that prevents coloring or tablet games

Primary outcomes:
measure: Introductory Information Form
timeFrame: The introductory information form will be filled out by the researcher during the first nebule treatment of the children's hospitalization. (Approximately 5 minute)
measure: Child Anxiety Scale-State
timeFrame: After the nebulization process is completed, the child anxiety scale-state scale will be asked to be filled out by the child's parent and the child. (Approximately 10minute). Repeat measurements will be taken 24 hours after the first nebulizer treatment.
measure: Treatment Adherence Questionnaire
timeFrame: The treatment compliance questionnaire developed by the researchers will be filled out by the researcher. (Approximately 5 minute) Repeat measurements will be taken 24 hours after the first nebulizer treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
state: Meram
Study officials:
References: