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Nursing CariesNCT05779826

Use of Play Dough in Children Receiving Nebulizer Therapy

A study testing Play dough in people with Nursing Caries and Nebulizer Therapy, run by Maltepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 3 to 6 years
Conditions the study is for
Nursing Caries, Nebulizer Therapy
What is being tested?
Play dough
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2021to 27 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Maltepe University

    Istanbul, Maltepe

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Playing Dough on Children's Adaptation to Nebulizer Treatment Children 3-6 Years Old Child Service: Randomized Controlled Study

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).

Read the detailed description

Mask use is generally preferred in children receiving nebulizer therapy. Wearing a mask and the noise made by the nebulizer device cause fear and stress in the child, leading to maladaptive behaviors such as crying, shouting, and trying to remove the mask. The aim of this study is to distract the child who receives nebulizer treatment by playing play dough and to present the results regarding compliance with the treatment.

Methods: This study was conducted in a single-center randomized controlled design. The sample size of the study was calculated in the program of G*Power 3.1.9.2 (Heinrich Heine University Düsseldorf, Germany). The sample size was found to be 35 children for each group. The research was conducted with a total of 80 children. There were 40 children in each group (research and control group). This study was carried out in the pediatric service of a public hospital in Istanbul between October 2021 and February 2022.

Procedures: The participants were divided into groups, the area to be played with play dough was prepared, vital signs were collected, data were collected with CANTEF and all recordings were made by the 1st researcher. She has 3 years of experience as a first research nurse.

In this study, the following procedure was applied respectively. Parents of children aged 3-6 years who are hospitalized in the pediatric service and who will be treated with nebulizers and who meet the sampling criteria will be informed about the study, and verbal and written consent will be obtained. A face-to-face interview method will be used to determine the socio-demographic and clinical characteristics of the children in data collection, and the data will be recorded in the Sick Child Diagnosis Form (SCDF) by the researcher. In order to evaluate the compliance of the children to the nebulizer treatment, the vital signs and behaviors will be evaluated by the researcher and the data will be recorded in the Child's Adherence to the Nebulizer Treatment Evaluation Form. For the random assignment of children to groups, children with an odd number of patient protocol numbers will form the research group, and children with an even number will form the control group. For example, the child with the protocol number 278861 was included in the research group, and the child with the protocol number 236724 was included in the control group. In this study, all evaluations were made in the same way for the children in the research and control groups. SCDF was filled in by obtaining information from the mother or father in the research group. 5 minutes before the nebulizer treatment, an area was created to play with play dough, the child was brought to a sitting position, vital signs were taken, his behavior was evaluated and recorded in the CANTEF. Nebulizer treatment was started at the beginning of the treatment (0. min), vital signs and behaviors were evaluated and recorded in the CANTEF, 5 minutes after the beginning of the treatment, vital signs and behaviors were evaluated and recorded in the CANTEF, 10 minutes after the start of the treatment, vital signs and behaviors were evaluated and recorded in the CANTEF, at the end of the treatment (15. min), the nebulizer treatment was terminated, the game activity was finished, and the behaviors were evaluated and recorded in the CANTEF. In the control group, the same procedures were performed in the same way without playing the play dough.

Instruments: Data were collected with the Sick Child Diagnosis Form (CSDFF) and the Child's Adherence to Nebulizer Treatment Evaluation Form (CANTEF). The forms were developed by the researchers based on the literature. The Sick Child Diagnosis Form (SCDF) is prepared for the child's age, gender, nationality, school attendance, whether he or she has been given nebulizer treatment before, if so, his reactions, reason for applying to the emergency department, diagnosis, whether he has a chronic disease, behavioral disorder such as attention deficit and hyperactivity disorder or not. It is a form consisting of 11 questions, which includes information about whether there is a diagnosed disease for respiratory diseases and whether there is a drug that he constantly uses if these diseases exist. While the first four questions determine the socio-demographic data of the child, the other seven questions describe the clinical features. Child's Adherence to Nebulizer Treatment Evaluation Form was prepared by the researcher and consultant to evaluate the vital signs and behaviors of children 5 minutes before the treatment, at the beginning of the treatment, 5 minutes after the start of the treatment, 10 minutes after the start of the treatment, and at the end of the treatment. In the evaluation of vital signs, there are 5 criteria: radial pulse, temporal fever, respiratory rate, respiratory function and SPO2. There are 10 behavioral criteria in the evaluation section of the child's behavior. For each behavioral criterion, there are two options, "yes" and "no". The 9th behavioral criterion will be evaluated from the beginning of the treatment (0. min). The 10th behavioral criterion will be evaluated only for the children in the research group. In the study, console type pulse oximeter, temporal thermometer and surgical mask were used in the research and control groups. In the research group, play dough was used during the treatment of children receiving nebulizer therapy.

Being tested
Play dough
Keywords
Nebulizer Therapy, Child, Play Dough, Adherence to treatment, Nursing, Play
Medical subject headings
Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Play doughOther

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

Study groups in NCT05779826
Study groupRoleWhat they receive
Play Dough GroupExperimentalPlay dough was played while receiving nebulizer therapy for the children in play dough group.
Receives: Other: Play dough
Routine Treatment GroupNo interventionPlay dough was not used for the children in the routine treatment group. Routine nebulizer treatment was applied to this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2023
  2. Study start1 Oct 2021
  3. Primary completion15 Feb 2022
  4. Study completion27 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05779826
Sponsor's protocol ID
2023/02-23
Status last verified
Apr 2023
First submitted
24 Feb 2023
Last updated
3 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27610343
  • 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.

    PubMed 27253598
  • 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.

    PubMed 26070582
  • 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.

    PubMed 25012949
  • 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.

    PubMed 25192760
  • 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.

    PubMed 21925588
  • 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.

    PubMed 26334412
  • 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.

    PubMed 29166200
  • 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.

    PubMed 27667353
  • 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.

    PubMed 33987291

Questions about this trial

What is this clinical trial studying?

A study testing Play dough in people with Nursing Caries and Nebulizer Therapy, run by Maltepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identifying the child's adherence with nebulizer therapy (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05779826, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.

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