Clinical trial NCT05779826: Use of Play Dough in Children Receiving Nebulizer Therapy
Official title: The Effect of Playing Dough on Children's Adaptation to Nebulizer Treatment Children 3-6 Years Old Child Service: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Nebulizer Therapy
Keywords: Nebulizer Therapy
Child
Play Dough
Adherence to treatment
Nursing
Play
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Identifying the child's adherence with nebulizer therapy
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University
state: Maltepe
Study officials:
affiliation: Martyr Prof. Dr. İlhan Varank Sancaktepe Education and Research Hospital
name: Aslıhan Aydoğmuş, MSc
role: PRINCIPAL_INVESTIGATOR
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