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Completed

NCT Number: NCT06251245

The Effects of Different Methods Used in Pediatric Oral Drug Administration

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.

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Key information

Conditions

Children, Only Fear

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acıbadem Health Group, Ataşehir Hospital

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Change in the child's fear level

    Time frame: 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

  2. Change in parent's fear level

    Time frame: 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

  3. Change in child's heart rate

    Time frame: 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.

  4. Change in child's oxygen saturation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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