Clinical trial NCT06769802: The Effect of Using Nebula Bear on Anxiety and Fear During Nebulizer Application in Children
Official title: The Effect of Using Nebula Bear on Anxiety and Fear During Nebulizer Application in Children: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Children
Nebulizer Therapy
Keywords: Child
Nebulizer Therapy
Nebulizer
Nursing
Fear
Anxiety
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was planned as a pre-test, post-test parallel group (invertion-control), randomized controlled experimental research type.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many respiratory system diseases are treated with inhalers. Providing inhaler treatment is provided by nebulizer devices. Taking the exact and effective dose of inhaler treatment affects the patient's recovery process. The use of nebulizer devices in children differs from that in adults. For children, the nebulizer may seem foreign and scary, which may cause them to reject inhaler treatment. Therefore, it is important to reduce anxiety and fear in children during nebulizer treatment. Since it is thought that the nebulizer bear, which is planned to be used in the study to reduce these negative situations caused by nebulizer treatment, may be effective in reducing anxiety and fear in children, it is thought that the study will have a positive physical and psychological contribution to children and parents.

Detailed description: Especially in the first years of their lives, children are vulnerable to respiratory system diseases because their lungs and their relationships are adequately examined. The first 5 years of childhood are the period when the lower respiratory tract is at a high rate. It threatens all classified characteristics of lower respiratory tract diseases such as pneumonia and bronchiolitis, and is the most important cause of morbidity and mortality, especially for developmental diseases. Lower respiratory tract lines are recorded to be responsible for a large portion of emergency department visits and treatment admissions. Even in a developed country such as the United States, bronchiolitis occurs most commonly among young infants in a region. Pneumonia accounts for 13% of the cases seen in young children. The countries with the highest death rates were determined as the Central African Republic, Chad and Somalia. Moreover, with crowded populations and high mortality rates, it is known that almost one-third of lower respiratory tract infection deaths in children under 5 years of age occur in India and Nigeria. A systematic review of pneumonia in children noted aspects of serious illness in infants and young children and a high-range group, emphasizing that infants had a high initial recovery and hospitalization rate of pneumonia.It was reported that 13,800 children under the age of 5 died every day worldwide in 2020, and a total of 5 million children under the age of 5 died in the world in 2020. When the investigators look at the deaths caused by infectious diseases in Turkey, the investigators see that deaths caused by pneumonia and sepsis are at the forefront and the number of pneumonia cases doubled from 2016 to 2019.While respiratory tract infections are a major problem in children, the SARS-CoV-2 virus, which caused the Covid-19 infection that emerged in 2019 and affected the whole world, has caused high mortality rates in patients with severe disease, the elderly and patients with low immune systems. Administration of medication with nebulizers can be applied to all age categories, including children. Children's psychomotor skills vary depending on their developmental period and age. For this reason, there is no single type of nebula device that they can use in every period. When choosing a nebula device, the child's tolerance as well as his psychomotor skills should be taken into consideration. Effective treatment becomes difficult, especially in infants and children, due to the reactions observed during nebula intake. Multiple steps are required to use nebule devices correctly, and many children do not achieve adequate response to treatment because they cannot use the correct technique. Because children vary in their ability to cooperate with treatments, this can lead to significant dose changes and potentially affect the effectiveness of inhalation treatments. Being hospitalized and encountering unfamiliar equipment such as a nebulizer device can create fear and anxiety for the child. Children taking medication with a nebulizer can be aggressive, angry and resistant. Studies have found that 50% of babies and young children cry during inhaler therapy. Most pediatric procedures are traumatic, painful and stressful for children. Nurses should apply atraumatic care to minimize the traumatic effects of hospitalization on the child. In this context, it is important for pediatric nurses to reduce the child's stress, anxiety and fear during nebulizer application. The higher the child's anxiety, the less ability he or she will have to cope. Studies emphasize that it is important to encourage effective coping methods to minimize anxiety in children experiencing a medical condition.In a study by Zhang et al., where they investigated the effect of interactive play on children's aerosol therapy experience, compliance was found to increase significantly. Interactive games have been shown to clearly reduce tension in children and improve adherence to treatment. With the help of technology, games can be created to increase motivation and distract during treatment. A review of the literature shows that the age range of 6-12 is commonly considered and that the most used technologies are computer-based games and that games are generally designed to distract or motivate in physical rehabilitation. Robots, devices with hand-held interfaces and voice interactive technologies are still little used. In the study conducted by Logan et al. with an interactive SR teddy bear, it was found that children's joy and agreeableness levels were higher compared to a normal plush animal. A systematic review shows that the use of tangible interactive devices has decreased even more since 2011. However, recent research shows that toys with tangible user interfaces are more effective than traditional devices and even tactile handheld devices. Children are selective and eager to learn from others. When the studies on children's interaction with robots are examined; It shows that young children easily establish relationships with robots as guides in an unfamiliar environment. Combining physical spaces in a technological game is perceived as easier and more fun than screen-based activities. Concrete objects to be used in the game can be toys that children are familiar with. As a result, when the literature was examined, it was determined that nebulizer treatment caused anxiety and fear in children and it was seen that studies on this subject were needed. In the light of this information, a randomized controlled study was planned based on the studies in the literature. The aim of this study was to examine the effect of nebulizer treatment on anxiety and fear in children.

Eligibility criteria: Inclusion Criteria:

Are between the ages of 4-6, Parent's ability to read and write Turkish, Accompanied by their parents, Children who are willing to participate in the research will be included in the research, They receive the first nebule treatment of their hospitalization.

Exclusion Criteria:

Have mental disabilities or communication problems, Visual or hearing impairment, Those who have any body function deficiency Children who routinely use nebulizers

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Primary outcomes:
measure: Parent and Child Information Form
timeFrame: It will be filled out by the parent within the first 60 minutes of the child's hospitalization. (Approximately 5 minute.)
measure: Child Fear Scale
timeFrame: It will be filled out by the researcher and parent 5 minutes before the procedure and 5 minutes after the procedure (Approximately 10 minute).
measure: Children's Anxiety Meter-State (CAM-S)
timeFrame: It will be filled out by the child 5 minutes before the procedure and 5 minutes after the procedure (Approximately 5 minute).
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
state: Meram
Study officials:
References: