The Effects of Different Methods Used in Pediatric Oral Drug Administration

Children, Only Clinical Trial

Official title:

The Effects of Different Methods Used in Oral Drug Administration on Fear in Children With Fever

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251245
• Other study ID #: ATADEK-2023/10
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: March 2024
• Source: Acibadem University
• Contact: Zehra Kan Öntürk, Assist Prof
• Phone: +905426523411
• Email: zehrakan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Fever is known as a defense mechanism of the body; Increased body temperature in children is one of the symptoms that frighten parents and is among the most common reasons for hospitalization. Pharmacological agents such as paracetamol and ibuprofen are often used in fever management, and if possible, oral administration of the suspension form of the drugs is preferred to reduce invasive practices. However, reasons such as children not liking the taste of the medicine, rejecting the medicine, or spitting or vomiting may cause difficulties in administering the medicine orally. More than one different method is used to administer these drugs, depending on the patient's age, general condition and compliance with the treatment. These; They can be listed as spoon, oral injector, medicine glass. As a result of the examination of the drug administration materials, it was stated that children are fear of the injector when the drugs are given with a injector, they may aspirate, and they do not have appropriate equipment to administer the drug. It is important for nurses to understand children's fears and their causes, to develop interventions to reduce fear, and to minimize possible traumatic effects during the hospitilization process.

In this study, the sample will be divided into two groups: experimental and control, and oral antipyretic medicine will be given by two different methods. An oral injector will be used in the experimental group and an oral medicine spoon will be used in the control group.

Hypotheses of the Study:

H0: There is no significant difference in the effect of the use of spoons and oral injectors in oral medication administration in children on the level of fear in children and parents.

H1: There is a significant difference in the fear level of using spoons and oral injectors in oral medication administration in children.

H2: There is a significant difference in the parents' fear level of using spoons and oral injectors in oral medication administration in children.

H3: There is a significant difference in the heart rate and oxygen saturation of children using spoons and oral injectors for oral medication administration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Children, Only
• Fear

Intervention

Procedure:
• Oral Injector
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
• Spoon
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

Locations

Country	Name	City	State
Turkey	Acibadem Health Group, Atasehir Hospital	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. 20 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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