Use of Play Dough in Children Receiving Nebulizer Therapy
NCT ID: NCT05779826
Last Updated: 2023-05-03
Study Results
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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COMPLETED
NA
80 participants
INTERVENTIONAL
2021-10-01
2022-02-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Play Dough Group
Play dough was played while receiving nebulizer therapy for the children in play dough group.
Play dough
In the play dough group, play dough was used during the treatment of children receiving nebulizer therapy.
Routine Treatment Group
Play dough was not used for the children in the routine treatment group. Routine nebulizer treatment was applied to this group.
No interventions assigned to this group
Interventions
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Play dough
In the play dough group, play dough was used during the treatment of children receiving nebulizer therapy.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* The child has a behavior disorder or disease that causes maladaptive behavior
3 Years
6 Years
ALL
No
Sponsors
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Maltepe University
OTHER
Responsible Party
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Behice Ekici
Assistant Professor, PhD
Principal Investigators
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Aslıhan Aydoğmuş, MSc
Role: PRINCIPAL_INVESTIGATOR
Martyr Prof. Dr. İlhan Varank Sancaktepe Education and Research Hospital
Locations
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Maltepe University
Istanbul, Maltepe, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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A Guide To Aerosol Delivery Devices for Respiratory Therapists. American Association for Respiratory Care
Other Identifiers
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2023/02-23
Identifier Type: -
Identifier Source: org_study_id
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