The Effects of Different Methods Used in Pediatric Oral Drug Administration
NCT ID: NCT06251245
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2023-11-15
2024-06-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental Group (Oral Injector)
Children who use oral injectors to give oral medication will constitute the experimental group.
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
Control group (Spoon)
Children who use spoons to give oral medication will constitute the control group.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* It is time for the child to sleep at the time of medication administration.
3 Years
6 Years
ALL
No
Sponsors
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Acibadem University
OTHER
Responsible Party
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Zehra Kan Onturk
Principal Investigator
Locations
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Acıbadem Health Group, Ataşehir Hospital
Istanbul, Ataşehir, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ATADEK-2023/10
Identifier Type: -
Identifier Source: org_study_id
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