The Effects of Different Methods Used in Pediatric Oral Drug Administration

Not Applicable

Completed

• Conditions: Fear; Children, Only
• Interventions: Procedure: Spoon; Procedure: Oral Injector

• Registration Number: NCT06251245
• Lead Sponsor: Acibadem University

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.

Detailed 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.

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-09
• Primary Completion: 2024-06-16
• Study Completion: 2024-06-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (Spoon)	Spoon	Children who use spoons to give oral medication will constitute the control group.
Experimental Group (Oral Injector)	Oral Injector	Children who use oral injectors to give oral medication will constitute the experimental group.

Primary Outcome Measures

Name	Time	Method
Change in child's heart rate	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	This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor.
Change in child's oxygen saturation	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	This outcome obtained with patient monitor.
Change in the child's fear level	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	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
Change in parent's fear level	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	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

Trial Locations

Locations (1)

Acıbadem Health Group, Ataşehir Hospital; 🇹🇷 Istanbul, Ataşehir, Turkey