Clinical trial NCT06668311: Play Dough and Picture Books: Reducing Anxiety and Fear in 3-6-Year-Olds During Nebulizer Treatment
Official title: The Impact of Play Dough and Picture Books on Physiological Parameters, Anxiety, and Fear in 3-6-Year-Old Children During Nebulizer Treatment: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nebulizer Therapy
Keywords: nursing care
nubulizer therapy
pediatric emergency department
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 25
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: 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: Inclusion Criteria:

* 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
* To be able to speak and understand Turkish
* Parents' consent to participate in the study

Exclusion Criteria:

* 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
* Having a physical disability that will prevent him/her from playing with playdough
* Having a cognitive disability that prevents reading books

Primary outcomes:
measure: Fear
timeFrame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
measure: Anxiety
timeFrame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
Secondary outcomes:
measure: Pulse Rate
timeFrame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
measure: Respiratory Rate
timeFrame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
measure: Saturation rate
timeFrame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Başkent University
state: Beşevler
Study officials:
References:
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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.