The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety on Children

NCT06339112 | Completed

• 1 other identifier: 2024/10
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. The population of the study, planned as a randomized controlled experimental study, will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment. According to the power analysis performed for the sample size, the power of the sample was calculated with the G\*Power 3.1 program, in line with the literature (Durak 2019; Özsamuri 2020). While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. Child Information Form, Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data.

Conditions

Fear; Anxiety; Inhalant Use

Keywords

fear; anxiety; children; emergency

Outcome Measures

Primary Outcomes (2)

• fear

  Child Fear Scale is used to evaluate the anxiety/fear level of children. The scale uses cartoon faces consisting of five pictures and the anxiety/fear level is evaluated with numbers between "0" and "4". The first picture shows a score of "0", that is, "no anxiety/fear is felt", and the last picture shows a score of "4", that is, "the most severe anxiety/fear". As the score increases, the level of anxiety/fear also increases.

  1 day

• anxiety

  Child Anxiety Scale-The State scale resembles a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. This scale, for children ages 4 to 10, asks children, "Imagine that all your anxious or nervous emotions are in the bulb or bottom part of the thermometer," or "If you are a little anxious or nervous, the emotions might move up a little bit on the thermometer." If you're very, very anxious or nervous, emotions can run rampant. "Put a line on the thermometer that shows how anxious or angry you are." To measure state anxiety, the child is asked to indicate what he or she is feeling "right now." The score can vary between 0-10.

  1 day

Study Arms (3)

Playing with toy nebulizer

EXPERIMENTAL

The child who needs to take inhaler medication is taken to the observation room. Before starting the procedure, the child will be introduced to the toy nebulizer. The toy nebulizer is shown to the child as an example and allowed to play with it so that the level of fear can be reduced.

Other: Playing with toy nebulizer

Cartoon

EXPERIMENTAL

Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. 2-3 minutes before starting drug treatment, the child will be allowed to watch cartoons according to his age group and will be encouraged to do so throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application of the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.

Other: Cartoon

Control

NO INTERVENTION

Routine care will be provided.

Interventions

Playing with toy nebulizer OTHER

The child who needs to take inhaler medication is taken to the observation room. Before starting the procedure, the toy nebulizer is introduced to the child. The toy nebulizer is shown to the child as an example and allowed to play, thus reducing the level of fear. Inhaler medication is given through a mask for 10 minutes. Vital signs (pulse) before and after the application. , blood pressure, SPo2, respiration), the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.

Playing with toy nebulizer

Cartoon OTHER

Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. 2-3 minutes before starting drug treatment, the child will be allowed to watch cartoons according to his age group and will be encouraged to do so throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.

Cartoon

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child is between 4 and 6 years old,
• No communication problems (visual/auditory/mental),
• Oxygen saturation is 90% or above,
• The child does not have a disease that may affect his/her life,
• Parent and child volunteering to participate in the research.

You may not qualify if:

• Nebul drug administration
• The child has visual, hearing, and mental disabilities,
• Having taken medication with a nebulizer before

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus State Hospital

Mersin, Turkey (Türkiye)

Location

Related Publications (6)

• Conk, Z. Başbakkal, Z. Yılmaz, H. Bolışık, B. (2013). Pediatri Hemşireliği, Ankara:Akademisyen Tıp Kitabevi.

  BACKGROUND

• Erdinç, E. (2022). Evde Nebülizatör Tedavisi Kime? Nasıl?. ToraksDergisi, 3(2), 21-25. Retrieved from https://turkthoracj.org/content/files/sayilar/93/buyuk/pdf_Toraksder_197.pdf

  BACKGROUND

• Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.

  PMID: 19230769 BACKGROUND

• Zengin M, Yayan EH, Duken ME. The Effects of a Therapeutic Play/Play Therapy Program on the Fear and Anxiety Levels of Hospitalized Children After Liver Transplantation. J Perianesth Nurs. 2021 Feb;36(1):81-85. doi: 10.1016/j.jopan.2020.07.006. Epub 2020 Nov 3.

  PMID: 33158746 BACKGROUND

• Coskunturk AE, Gozen D. The Effect of Interactive Therapeutic Play Education Program on Anxiety Levels of Children Undergoing Cardiac Surgery and Their Mothers. J Perianesth Nurs. 2018 Dec;33(6):781-789. doi: 10.1016/j.jopan.2017.07.009. Epub 2018 Feb 3.

  PMID: 29398304 BACKGROUND

• 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.

  PMID: 33742204 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Emergencies

Condition Hierarchy (Ancestors)

Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Model Details: A randomized controlled experimental study

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 1, 2024
• Study Start: June 1, 2024
• Primary Completion: November 19, 2024
• Study Completion: November 19, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)