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Play Dough and Picture Books: Reducing Anxiety and Fear in 3-6-Year-Olds During Nebulizer Treatment

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06668311
Enrollment
25
Registered
2024-10-31
Start date
2024-11-15
Completion date
2025-11-15
Last updated
2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nebulizer Therapy

Keywords

nursing care, nubulizer therapy, pediatric emergency department

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.

Interventions

1. 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.

OTHERpicture book reading

1. 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.

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fear5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatmentThe 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.
Anxiety5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatmentThe 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

MeasureTime frameDescription
Pulse Rate5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatmentMaintaining and normalizing pulse rate within normal range (75-115 per minute)
Respiratory Rate5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatmentMaintaining and normalizing respiratory rate within normal range (20-25 per minute)
Saturation rate5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatmentMaintaining and normalizing saturation rate within normal range (95-100%)

Countries

Turkey (Türkiye)

Contacts

Primary Contactİlçim Ercan Koyuncu, RN, MSc
ilcimercan@baskent.edu.tr+905534700629

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026