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

NCT ID: NCT06668311

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Nebulizer Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

play dough

Intervention Type 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.

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.

Group Type EXPERIMENTAL

picture book reading

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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play dough

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.

Intervention Type OTHER

picture 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Ilcim Ercan Koyuncu

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Başkent University

Ankara, Beşevler, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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İlçim Ercan Koyuncu, RN, MSc

Role: CONTACT

+905534700629

Facility Contacts

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İlçim Ercan Koyuncu, RN, MSc

Role: primary

05534700629

Ayşe Ay, Asisst Prof

Role: backup

Nebahat Ayten, RN

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 25012949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16899849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17411409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26070582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30651182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33742204 (View on PubMed)

Other Identifiers

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Nebulizer Treatment

Identifier Type: -

Identifier Source: org_study_id

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