Play Dough and Picture Books: Reducing Anxiety and Fear in 3-6-Year-Olds During Nebulizer Treatment
October 31, 2024 updated by: Ilcim Ercan Koyuncu, Baskent University
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: İlçim Ercan Koyuncu, RN, MSc
- Phone Number: +905534700629
- Email: ilcimercan@baskent.edu.tr
Study Locations
-
-
Beşevler
-
Ankara, Beşevler, Turkey, 60300
- Baskent University
-
Contact:
- İlçim Ercan Koyuncu, RN, MSc
- Phone Number: 05534700629
- Email: ilcimercan@hotmail.com
-
Contact:
- Ayşe Ay, Asisst Prof
-
Contact:
- Nebahat Ayten, RN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Play Dough Group
The child will be provided with play dough five minutes before the commencement of nebulizer treatment and will be allowed to continue playing with it throughout the treatment.
|
|
|
Experimental: Picture Book Reading group
Five minutes before the commencement of nebulizer treatment, the child will be provided with a picture book and will be allowed to continue reading it throughout the treatment.
|
|
|
No Intervention: Control Group
Nebulizer treatment of the child will be performed by the routine protocols currently applied in the emergency department.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fear
Time Frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
|
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.
|
5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
|
|
Anxiety
Time Frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
|
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.
|
5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulse Rate
Time Frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
|
Maintaining and normalizing pulse rate within normal range (75-115 per minute)
|
5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
|
|
Respiratory Rate
Time Frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
|
Maintaining and normalizing respiratory rate within normal range (20-25 per minute)
|
5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
|
|
Saturation rate
Time Frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
|
Maintaining and normalizing saturation rate within normal range (95-100%)
|
5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- DiBlasi RM. Clinical Controversies in Aerosol Therapy for Infants and Children. Respir Care. 2015 Jun;60(6):894-914; discussion 914-6. doi: 10.4187/respcare.04137.
- Goralski JL, Davis SD. Breathing easier: addressing the challenges of aerosolizing medications to infants and preschoolers. Respir Med. 2014 Aug;108(8):1069-74. doi: 10.1016/j.rmed.2014.06.004. Epub 2014 Jun 25.
- 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.
- Esposito-Festen J, Ijsselstijn H, Hop W, van Vliet F, de Jongste J, Tiddens H. Aerosol therapy by pressured metered-dose inhaler-spacer in sleeping young children: to do or not to do? Chest. 2006 Aug;130(2):487-92. doi: 10.1378/chest.130.2.487.
- Erzinger S, Schueepp KG, Brooks-Wildhaber J, Devadason SG, Wildhaber JH. Facemasks and aerosol delivery in vivo. J Aerosol Med. 2007;20 Suppl 1:S78-83; discussion S83-4. doi: 10.1089/jam.2007.0572.
- Supat B, Brennan JJ, Vilke GM, Ishimine P, Hsia RY, Castillo EM. Characterizing pediatric high frequency users of California emergency departments. Am J Emerg Med. 2019 Sep;37(9):1699-1704. doi: 10.1016/j.ajem.2018.12.015. Epub 2018 Dec 12.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 15, 2024
Primary Completion (Estimated)
November 15, 2024
Study Completion (Estimated)
November 15, 2025
Study Registration Dates
First Submitted
October 30, 2024
First Submitted That Met QC Criteria
October 30, 2024
First Posted (Actual)
October 31, 2024
Study Record Updates
Last Update Posted (Estimated)
November 1, 2024
Last Update Submitted That Met QC Criteria
October 31, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Nebulizer Treatment
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.