Clinical trial NCT05242939: Active and Passive Distraction Techniques
Official title: Comparison of Active and Passive Distraction Techniques in Reducing Anxiety and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Inhalation Therapy; Complications
Keywords: inhalation therapy
child
fear
cartoon
video game
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 99
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Treatment methods with nebulizers are used in the treatment of many diseases such as asthma, bronchitis, bronchiolitis and cystic fibrosis in children. Because inhalation therapy with a face mask is scary for children, it can be difficult to provide this therapy effectively and safely. Adaptation of the child and family is important for the success of inhalation therapy. Distraction techniques are among the most commonly used cognitive/behavioral methods. It determines the effect of "playing video games" and "watching cartoons" methods, which are active distraction methods during inhalation therapy, on the level of fear and anxiety.

Detailed description: Hospitalization can be a threatening and stressful experience for children. Unfamiliar with the environment and medical procedures and unaware of the reasons for hospitalization can result in children's anger, uncertainty, anxiety and feelings of helplessness. Anxiety and fear are the most frequently reported among these negative reactions. In addition, high levels of anxiety and fear can be harmful to children's physiological and psychological health. Excessive anxiety and fear also inhibit children's effectiveness in coping with medical treatment and increase their negative emotions. It is thought that the levels of anxiety and fear in children will increase even more when they apply to the emergency services, especially in acute situations. Children who present to the emergency department with respiratory distress and cough can be given inhalation therapy as a result of physical examination and other tests. Today, inhalation therapy with a nebulizer is one of the most common and frequently used methods. Treatment methods with nebulizers are used in the treatment of many diseases such as asthma, bronchitis, bronchiolitis and cystic fibrosis in children. Because inhalation therapy with a face mask is scary for children, it can be difficult to provide this therapy effectively and safely. Adaptation of the child and family is important for the success of inhalation therapy.

Evidence-based distraction methods can be used to provide effective inhalation and reduce fear of children. Recent research has focused on the use of non-pharmacological methods in the management of pain in children. Non-pharmacological methods used to manage pain and anxiety in children fall into three main groups; supportive methods, cognitive/behavioral methods, and physical methods. Distraction techniques are among the most commonly used cognitive/behavioral methods. It has been reported that distraction cards, watching cartoons, using kaleidoscope, and listening to music reduce pain, anxiety and fear levels. It is noteworthy that similar studies mostly focused on invasive applications. On the other hand, it is stated that studies on the effect of non-pharmacological methods in inhalation therapy, which is one of the common non-invasive procedures in children, are still limited. Another aim of this study is; This study determines the effect of "playing video games" and "watching cartoons" methods, which are active distraction methods during inhalation therapy, on the level of fear and anxiety.

Eligibility criteria: Inclusion Criteria:

1. Children aged 4-7 years
2. Children who have not undergone any painful procedures before the procedure
3. Parents with smartphones
4. Children and parents who can speak and understand Turkish
5. Children of parents who agreed to participate in the study and whose written consent form was obtained from them will be included in the study.

Exclusion Criteria:

1. Having a neurological disorder,
2. Congenital anomaly,
3. Growth and development retardation,
4. Hearing impaired,
5. Having visual impairment,
6. Having a chronic disease,
7. Using anti-epileptic drugs in the last 6 hours,
8. Children with suspected COVID-19 will not be included in the study.

Primary outcomes:
measure: Child Fear Scale (CFS) Measure
timeFrame: 1 year
measure: Child Anxiety Scale-State (CAS-S)
timeFrame: 1 year
Secondary outcomes:
measure: Pulse oximetry
timeFrame: 1 year
measure: Heartbeat
timeFrame: 1 year
measure: Respiratory
timeFrame: 1 year
measure: Spo2
timeFrame: 1 year
Other outcomes:
Locations:
city: Kepez
country: Turkey
facility: Akdeniz University
state: Antalya
Study officials:
affiliation: Akdeniz Univercity
name: Uğur Gül
role: PRINCIPAL_INVESTIGATOR
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