NCT05779826

Brief Summary

The aim of this study is to present the results of the effect of playing with play dough on treatment compliance in children aged 3-6 years receiving nebulizer therapy. In the randomized controlled study, 80 children who were hospitalized in the pediatric ward of a public hospital and met the inclusion criteria were equally divided into 2 groups. Play dough was played while receiving nebulizer therapy for the children in group 1 (research group). Play dough was not used for the children in the 2nd group. The compliance of the children in the two groups to the treatment was evaluated with the Child's Adherence to Nebulizer Treatment Evaluation Form (CANTEF).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

February 24, 2023

Last Update Submit

April 28, 2023

Conditions

Keywords

Nebulizer TherapyChildPlay DoughAdherence to treatmentNursingPlay

Outcome Measures

Primary Outcomes (1)

  • Identifying the child's adherence with nebulizer therapy

    The child's behavior during nebulizer therapy was assessed using the Child's Nebulizer Treatment Compliance Evaluation Form. In this form, body temperature, pulse, respiratory rate, saturation, respiratory function, and behaviors were evaluated. When assessing behaviors, she is "irritable", "crying", "not allowing her vital signs to be taken", "very active, not sitting up", "wanting to go to her parent's lap", "yelling and screaming" ', 'not communicating with the researcher', 'removing the mask from his face' criteria were evaluated. The answers were evaluated as "yes" or "no". Children with a high rate of yes answers were considered non-adherent to treatment.

    Children's behavior and vital signs were evaluated 5 minutes before the treatment. evaluated for 15 minutes during treatment. Evaluation was done every 5 minutes.

Study Arms (2)

Play Dough Group

EXPERIMENTAL

Play dough was played while receiving nebulizer therapy for the children in play dough group.

Other: Play dough

Routine Treatment Group

NO INTERVENTION

Play dough was not used for the children in the routine treatment group. Routine nebulizer treatment was applied to this group.

Interventions

In the play dough group, play dough was used during the treatment of children receiving nebulizer therapy.

Play Dough Group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent's consent to participate in the study
  • Stable clinical status
  • The child's motor skills should be at a level to be able to play with play dough and should be developed according to his age,
  • The child's ability to speak and understand Turkish.

You may not qualify if:

  • Any physical or mental disability that prevents the child from playing with play dough
  • The child has a behavior disorder or disease that causes maladaptive behavior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University

Istanbul, Maltepe, Turkey (Türkiye)

Location

Related Publications (10)

  • Ari A. Drug delivery interfaces: A way to optimize inhalation therapy in spontaneously breathing children. World J Clin Pediatr. 2016 Aug 8;5(3):281-7. doi: 10.5409/wjcp.v5.i3.281. eCollection 2016 Aug 8.

    PMID: 27610343BACKGROUND
  • Caleffi CC, Rocha PK, Anders JC, Souza AI, Burciaga VB, Serapiao Lda S. Contribution of structured therapeutic play in a nursing care model for hospitalised children. Rev Gaucha Enferm. 2016 Jun;37(2):e58131. doi: 10.1590/1983-1447.2016.02.58131. Epub 2016 May 31. English, Portuguese.

    PMID: 27253598BACKGROUND
  • 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: 26070582BACKGROUND
  • 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: 25012949BACKGROUND
  • Hoiseth M, Keitsch MM, Holm Hopperstad M. Interactions between caregivers and young children: exploring pedagogical tact in nebulizer treatment. Qual Health Res. 2014 Dec;24(12):1622-34. doi: 10.1177/1049732314549017. Epub 2014 Sep 5.

    PMID: 25192760BACKGROUND
  • Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs. 2012 Dec;27(6):652-81. doi: 10.1016/j.pedn.2011.08.001. Epub 2011 Oct 13.

    PMID: 21925588BACKGROUND
  • Lima KY, Santos VE. [Play as a care strategy for children with cancer]. Rev Gaucha Enferm. 2015 Jun;36(2):76-81. doi: 10.1590/1983-1447.2015.02.51514. Portuguese.

    PMID: 26334412BACKGROUND
  • Shinta Devi NLP, Nurhaeni N, Hayati H. Effect of Audiovisual Distraction on Distress and Oxygenation Status in Children Receiving Aerosol Therapy. Compr Child Adolesc Nurs. 2017;40(sup1):14-21. doi: 10.1080/24694193.2017.1386966.

    PMID: 29166200BACKGROUND
  • Stewart MW. Therapeutic Play Intervention. J Perianesth Nurs. 2016 Oct;31(5):452-6. doi: 10.1016/j.jopan.2016.07.001. No abstract available.

    PMID: 27667353BACKGROUND
  • Ari A. A path to successful patient outcomes through aerosol drug delivery to children: a narrative review. Ann Transl Med. 2021 Apr;9(7):593. doi: 10.21037/atm-20-1682.

    PMID: 33987291BACKGROUND

Related Links

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Aslıhan Aydoğmuş, MSc

    Martyr Prof. Dr. İlhan Varank Sancaktepe Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 22, 2023

Study Start

October 1, 2021

Primary Completion

February 15, 2022

Study Completion

February 27, 2022

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations