Children, OnlyNCT06251245
The Effects of Different Methods Used in Pediatric Oral Drug Administration
A study testing Oral Injector and Spoon in people with Children, Only and Fear, run by Acibadem University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Children, Only, Fear
- What is being tested?
- Oral Injector and Spoon
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 16 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Health Group, Ataşehir Hospital
Istanbul, Ataşehir, 34750
About this study
Official title: The Effects of Different Methods Used in Oral Drug Administration on Fear in Children With Fever
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.
Read the 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.
- Conditions
- Children, Only, Fear
- Being tested
- Oral Injector, Spoon
- Keywords
- oral medication administration, fear, children, pediatric nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral InjectorProcedure or surgery
- 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
SpoonProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Oral Injector) | Experimental | Children who use oral injectors to give oral medication will constitute the experimental group. Receives: Procedure: Oral Injector |
| Control group (Spoon) | Other | Children who use spoons to give oral medication will constitute the control group. Receives: Procedure: Spoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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.
Measured: 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
Change in child's oxygen saturation
This outcome obtained with patient monitor.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Nov 2023
- Primary completion16 Jun 2024
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Children, OnlyStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251245
- Sponsor's protocol ID
- ATADEK-2023/10
- Status last verified
- Mar 2025
- First submitted
- 2 Feb 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22554162Alessandrini 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.
PubMed 35987466Chiappini 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.
PubMed 27810155Talegaonkar 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.
PubMed 36965592Turgut 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.
PubMed 36905910
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Methods Used in Oral Drug Administration on Fear in Children With Fever
- ClinicalTrials.gov ID
- NCT06251245
- Acronym / sponsor ID
- ATADEK-2023/10
- Conditions
- Children, Only, Fear
- Keywords
- oral medication administration, fear, children, pediatric nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Oral Injector) | Experimental | Procedure: Oral InjectorChildren who use oral injectors to give oral medication will constitute the experimental group. |
| Control group (Spoon) | Other | Procedure: SpoonChildren who use spoons to give oral medication will constitute the control group. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Experimental Group (Oral Injector) |
| 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 | Procedure or surgery | Control group (Spoon) |
Primary outcome
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Results publication: PubMed 22554162Akram 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.
- Results publication: PubMed 35987466Alessandrini 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.
- Results publication: PubMed 27810155Chiappini 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.
- Results publication: PubMed 36965592Talegaonkar 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.
- Results publication: PubMed 36905910Turgut 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Injector and Spoon in people with Children, Only and Fear, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06251245, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.