Clinical trial NCT06251245: The Effects of Different Methods Used in Pediatric Oral Drug Administration
Official title: The Effects of Different Methods Used in Oral Drug Administration on Fear in Children with Fever
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children, Only
Fear
Keywords: oral medication administration
fear
children
pediatric nursing
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the child's fear level
timeFrame: 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
measure: Change in parent's fear level
timeFrame: 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
measure: Change in child's heart rate
timeFrame: 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
measure: Change in child's oxygen saturation
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Health Group, Ataşehir Hospital
state: Ataşehir
Study officials:
References:
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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.