The Effects of Different Methods Used in Pediatric Oral Drug Administration

NCT06251245 | Completed

• 1 other identifier: ATADEK-2023/10
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of the use of spoons and oral injectors on the level of fear in children with fever in oral medication administration.

Conditions

Children, Only; Fear

Keywords

oral medication administration; fear; children; pediatric nursing

Outcome Measures

Primary Outcomes (4)

• Change in the child's fear level

  Child Fear Scale is used to measure the level of fear in children. This scale consists of five different facial expressions ranging from 0 = this face is not afraid at all to 4 = the most fear possible. The child and the parents are asked to look at these faces and choose the most appropriate expression to describe their fear. It is used in both children and parents to evaluate fear before and during the procedure

  at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed

• Change in parent's fear level

  Child Fear Scale is used to measure the level of fear in children. This scale consists of five different facial expressions ranging from 0 = this face is not afraid at all to 4 = the most fear possible. The child and the parents are asked to look at these faces and choose the most appropriate expression to describe their fear. It is used in both children and parents to evaluate fear before and during the procedure

  at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed

• Change in child's heart rate

  This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor.

  at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed

• Change in child's oxygen saturation

  This outcome obtained with patient monitor.

  at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed

Study Arms (2)

Experimental Group (Oral Injector)

EXPERIMENTAL

Children who use oral injectors to give oral medication will constitute the experimental group.

Procedure: Oral Injector

Control group (Spoon)

OTHER

Children who use spoons to give oral medication will constitute the control group.

Procedure: Spoon

Interventions

Oral Injector PROCEDURE

* Admission of a child with fever to the pediatric inpatient ward * Obtaining parental consent * Completing the patient identification data collection form * Obtaining the child's consent * Applying the "Child Fear Scale" to the child * Measuring the child's pulse and SpO2 * Applying the "Child Fear Scale" to the parent * Explaining the procedure using the educational therapeutic play method before oral medication administration * Administering the "Child Fear Scale" to the child and parent before oral medication administration * Measurement of the child's pulse and SpO2 * • Experimental Group (Giving the medicine orally to the child with an Oral Injector) * Application of the "Child Fear Scale" to the child and parent after oral medication administration * Measurement of the child's pulse and SpO2

Experimental Group (Oral Injector)

Spoon PROCEDURE

* Admission of a child with fever to the pediatric inpatient ward * Obtaining parental consent * Completing the patient identification data collection form * Obtaining the child's consent * Applying the "Child Fear Scale" to the child * Measuring the child's pulse and SpO2 * Applying the "Child Fear Scale" to the parent * Explaining the procedure using the educational therapeutic play method before oral medication administration * Administering the "Child Fear Scale" to the child and parent before oral medication administration * Measurement of the child's pulse and SpO2 * Control Group (Giving the medicine orally to the child with an oral medication spoon) * Application of the "Child Fear Scale" to the child and parent after oral medication administration * Measurement of the child's pulse and SpO2

Control group (Spoon)

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-6 and their parents,
• Children with fever,
• Children who have been ordered to take oral medication for fever in their treatment,
• Able to express himself cognitively,
• Able to speak and understand Turkish

You may not qualify if:

• Children who have a disease that may prevent them from expressing their fear
• It is time for the child to sleep at the time of medication administration.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem Health Group, Ataşehir Hospital

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

Location

Related Publications (5)

• Akram G, Mullen AB. Paediatric nurses' knowledge and practice of mixing medication into foodstuff. Int J Pharm Pract. 2012 Jun;20(3):191-8. doi: 10.1111/j.2042-7174.2011.00179.x. Epub 2011 Nov 9.

  PMID: 22554162 BACKGROUND

• Alessandrini E, Walsh J, Salunke S. Usability of administration devices for oral and respiratory medicines: Views from a UK primary school. Eur J Pharm Biopharm. 2022 Sep;178:150-158. doi: 10.1016/j.ejpb.2022.08.006. Epub 2022 Aug 17.

  PMID: 35987466 BACKGROUND

• Chiappini E, Venturini E, Remaschi G, Principi N, Longhi R, Tovo PA, Becherucci P, Bonsignori F, Esposito S, Festini F, Galli L, Lucchesi B, Mugelli A, Marseglia GL, de Martino M; Italian Pediatric Society Panel for the Management of Fever in Children. 2016 Update of the Italian Pediatric Society Guidelines for Management of Fever in Children. J Pediatr. 2017 Jan;180:177-183.e1. doi: 10.1016/j.jpeds.2016.09.043. Epub 2016 Oct 31.

  PMID: 27810155 BACKGROUND

• Talegaonkar S, Chitlangia A, Pradhan V, More S, Salunke S. Uncovering caregiver concerns: 5 key issues that still remain unresolved in administration of oral medicines for children in India. Eur J Pharm Biopharm. 2023 Jun;187:166-174. doi: 10.1016/j.ejpb.2023.03.009. Epub 2023 Mar 23.

  PMID: 36965592 BACKGROUND

• Turgut MA, Turkmen AS. The effect of lighted toy on reducing pain and fear during blood collection in children between 3 and 6 years: A randomized control trial. J Pediatr Nurs. 2023 May-Jun;70:111-116. doi: 10.1016/j.pedn.2023.02.009. Epub 2023 Mar 9.

  PMID: 36905910 BACKGROUND

MeSH Terms

Interventions

spoon protein, Drosophila

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: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 9, 2024
• Study Start: November 15, 2023
• Primary Completion: June 16, 2024
• Study Completion: June 16, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)