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

NCT06668311 | Not Yet Recruiting

• 1 other identifier: Nebulizer Treatment
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Nebulizer Therapy

Keywords

nursing care; nubulizer therapy; pediatric emergency department

Outcome Measures

Primary Outcomes (2)

• 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.

  5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment

• 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.

  5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment

Secondary Outcomes (3)

• Pulse Rate

  5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment

• Respiratory Rate

  5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment

• Saturation rate

  5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment

Study Arms (3)

Play Dough Group

EXPERIMENTAL

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.

Other: play dough

Picture Book Reading group

EXPERIMENTAL

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.

Other: picture book reading

Control Group

NO INTERVENTION

Nebulizer treatment of the child will be performed by the routine protocols currently applied in the emergency department.

Interventions

play dough OTHER

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.

Play Dough Group

picture book reading OTHER

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.

Picture Book Reading group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Başkent University

Ankara, Beşevler, 60300, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 25012949 BACKGROUND

• 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.

  PMID: 16899849 BACKGROUND

• 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.

  PMID: 17411409 BACKGROUND

• 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.

  PMID: 26070582 BACKGROUND

• 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.

  PMID: 30651182 BACKGROUND

• 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.

  PMID: 33742204 BACKGROUND

Related Links

• Related Info
• Related Info
• Related Info

Central Study Contacts

İlçim Ercan Koyuncu, RN, MSc

CONTACT

+905534700629; ilcimercan@baskent.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: November 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)