About this trial
This randomized controlled trial aims to evaluate the effects of play dough and picture books on physiological parameters, anxiety, and fear levels in children aged 3-6 undergoing nebulizer treatment. The trial will involve two groups: an intervention group engaging with play dough and picture books during treatment and a control group receiving standard care. Physiological data, including heart rate and oxygen saturation, will be monitored alongside behavioral assessments of anxiety and fear. This study seeks to determine whether these non-pharmacological interventions can alleviate distress in young children, contributing to more child-friendly treatment approaches in pediatric healthcare.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being in the 3-6 age group
Follow-up in the emergency department with upper or lower respiratory tract disease
Application of nebuliser therapy
Staying with the parent during the research
Disqualifiers
Having a disease that causes maladaptive behaviours (ADHD, Autism, etc.)
Having a chronic disease affecting the respiratory tract
Chronic diseases or serious infections affecting vital signs
Implementation of droplet or contact isolation
Trial design
Parallel
Treatments tested in this trial
play dough
Other intervention1. Children and families will be informed about the purpose of the study and their verbal and written consent will be obtained. 2. The first part of the Patient Information Form will be completed for children who accept the study. 3. The second part of the Patient Information Form will be completed five minutes before nebulizer treatment. 4. Five minutes before nebulizer treatment, play dough will be given to the child. 5. The child will be allowed to play with the play dough during the nebulizer treatment. 6. The second part of the Patient Information Form will be filled in at the 5th minute of the treatment and after the treatment is over. 7. The application will take approximately 15 minutes.
picture book reading
Other intervention1. Children and families will be informed about the purpose of the study and their verbal and written consent will be obtained. 2. The first part of the Patient Information Form will be completed for children who accept the study. 3. The second part of the Patient Information Form will be completed five minutes before nebulizer treatment. 4. Five minutes before nebulizer treatment, the child will be given a picture book. 5. Picture book will be read to the child during the treatment. 6. The second part of the Patient Information Form will be filled in at the 5th minute of the treatment and after the treatment is over. 7. The application will take approximately 15 minutes.
Treatment groups
Trial outcomes
Primary outcomes
Fear
The scale was developed for the age group of 4-10 years and is used in studies up to 3 years of age. It consists of five facial expressions ranging from neutral (0 points: no anxiety) to frightened face (4 points: severe anxiety). The child is asked to mark the degree of fear by choosing the most appropriate facial expression. As the score obtained from the scale increases, the child's level of fear increases.
Anxiety
The scale is in the form of a thermometer. The bottom part of the thermometer is labelled as 'Calm: Not tense or anxious (0 points)', and the top part is rated as "Very tense or anxious (10 points)". To assess the child's state of anxiety, the child is asked to mark how he/she feels 'right now' on the thermometer. As the score obtained from the scale increases, the anxiety level of the child increases.
Secondary outcomes
Pulse Rate
Maintaining and normalizing pulse rate within normal range (75-115 per minute)
Respiratory Rate
Maintaining and normalizing respiratory rate within normal range (20-25 per minute)
Saturation rate
Maintaining and normalizing saturation rate within normal range (95-100%)
Sponsors and contacts
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