Nursing CariesEWWFBFMCNCT06537206
Foot Bath on Fever Management in Children (EWWFBFMC)
A study testing Application Footbath in people with Nursing Caries, run by Atlas University at 2 sites in Turkey (Türkiye).
Trial summary
Reducing the dependency on medication in lowering fever, which is one of the most common symptoms in childhood, and developing safer and more feasible alternative methods are important for child health. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Application Footbath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Aug 2024to 30 Aug 2025
- 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child is between 1-5 years old. The child has presented to the emergency department with a fever of 38.3°C or higher.
- The child is a patient with "Green Area" (specific condition or disease). The child has no chronic illness. The child has not used any other antipyretic medication in the last 6 hours.
- The child has been administered 15 mg/kg of oral paracetamol as prescribed by the doctor.
- The child and their parent(s) have volunteered to participate in the study. Written consent from the parent(s) is obtained.
Who cannot join
- Individuals who have not agreed to participate voluntarily in the study.
- Children who have been unable to take paracetamol due to spillage or vomiting.
- Children with compromised skin integrity.
- Individuals who have undergone surgical procedures that would hinder the child's activity.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Atlas Üniversity
Kağıthane, Istanbul, 34098
Atlas University
Kâğıthane, Istanbul, 34098
About this study
Official title: Effect of Warm Water Foot Bath on Fever Management in Children: A Randomized Controlled Trial
Reducing the dependency on medication in lowering fever, which is one of the most common symptoms in childhood, and developing safer and more feasible alternative methods are important for child health. This study aims to evaluate the effect of warm water foot baths on vital signs and pain in children, and to scientifically investigate this effect through a randomized controlled trial.
Read the detailed description
Fever is one of the most common symptoms in childhood, especially in children under the age of five. While it is the most frequent reason for visits to healthcare institutions, it accounts for 25% of pediatric emergency visits. Lack of knowledge about fever in parents triggers fear, and the thought that it can cause seizures, disability, and brain damage induces anxiety and panic in many families. In the presence of anxiety and panic, families may quickly resort to early and incorrect treatment. Administering less medication than necessary for low fevers or high doses for high fevers, repeated use of antipyretics, and inappropriate use of antibiotics lead to ineffective management, resulting in an increase in repeated emergency visits and unnecessary crowding in emergency services. Published guidelines on high fever have emphasized focusing on pain and comfort rather than reducing fever in children. It is reported that foot baths, preferred in pain management, effectively reduce pain and increase comfort. Additionally, guidelines related to fever highlight that warm applications after medication administration can effectively lower persistent fever. Warm water foot bath therapy dilates blood vessels, increases blood circulation, releases heat as sweat, and supports increased oxygenation. Increased circulation improves tissue nutrition and reduces stress. Literature has shown that body temperature decreased in children who received a warm water foot bath. Similarly, studies reported that warm water foot baths were effective in reducing fever in individuals with complaints of high fever.
- Conditions
- Nursing Caries
- Being tested
- Application Footbath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application FootbathOther
The foot bath application for the experimental group will be applied with water at 38-40 degrees Celsius for an average of 10 minutes under thermometer control. Immediately afterward, the second physiological parameters will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Application Footbath | Experimental | The experimental group will then receive the first foot bath with water at 38-40°C for approximately 10 minutes. After this, the second set of physiological parameters will be measured at the 40th minute. The child will rest for 10 minutes, followed by measurement and recording of the third set of parameters at the 50th minute.
A second foot bath at 38-40°C will be applied for another 10 minutes. After this, the fourth set of physiological parameters will be measured, and the FLACC pain score (2nd measurement) will be recorded by the same nurse observer and parent at the 60th minute. The procedure will then be terminated. Receives: Other: Application Footbath |
| Control Group | No intervention | Approximately 10 minutes after the application of the antipyretic, the adaptation of the family and the child to the clinic will be awaited. Children and families who meet the sample selection criteria and verbally and in writing agree to participate in the study will be included. A data collection form will be applied to all members of the sample group, and the information will be recorded by the researcher on the form. (20th minute) The parents of the children and the observer nurse will be explained how to use the FLACC pain assessment scale. For inter-observer agreement, the nurse administering the antipyretic and the accompanying parent will simultaneously evaluate using the scale. Throughout the process, the parents of both groups will be with the child. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC SCORE
Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain
Measured: 0 minute
FLACC SCORE
Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain
Measured: 30 minute
FLACC SCORE
Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain
Measured: 50 minute
Secondary outcomes (5)
Heart Rate
Heart Rate
Measured: 0 minute
Heart Rate
Heart Rate
Measured: 30 minute
Heart Rate
Heart Rate
Measured: 40 minute
Heart Rate
Heart Rate
Measured: 50 minute
Heart Rate
Heart Rate
Measured: 60 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start30 Aug 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- 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
- Model description
- Randomized control
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Collaborators
- Koç University
- Responsible party
- Principal investigator, Sermin Dinc, Atlas University
- Investigators
- semin dinç, Principal investigator, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537206
- Sponsor's protocol ID
- E-2268639050.99-46589
- Acronym
- EWWFBFMC
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Warm Water Foot Bath on Fever Management in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06537206
- Acronym / sponsor ID
- EWWFBFMC / E-2268639050.99-46589
- Conditions
- Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Collaborators
- Koç University
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 5 Aug 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.
Reducing the dependency on medication in lowering fever, which is one of the most common symptoms in childhood, and developing safer and more feasible alternative methods are important for child health. This study aims to evaluate the effect of warm water foot baths on vital signs and pain in children, and to scientifically investigate this effect through a randomized controlled trial.
Detailed description
Fever is one of the most common symptoms in childhood, especially in children under the age of five. While it is the most frequent reason for visits to healthcare institutions, it accounts for 25% of pediatric emergency visits. Lack of knowledge about fever in parents triggers fear, and the thought that it can cause seizures, disability, and brain damage induces anxiety and panic in many families. In the presence of anxiety and panic, families may quickly resort to early and incorrect treatment. Administering less medication than necessary for low fevers or high doses for high fevers, repeated use of antipyretics, and inappropriate use of antibiotics lead to ineffective management, resulting in an increase in repeated emergency visits and unnecessary crowding in emergency services. Published guidelines on high fever have emphasized focusing on pain and comfort rather than reducing fever in children. It is reported that foot baths, preferred in pain management, effectively reduce pain and increase comfort. Additionally, guidelines related to fever highlight that warm applications after medication administration can effectively lower persistent fever. Warm water foot bath therapy dilates blood vessels, increases blood circulation, releases heat as sweat, and supports increased oxygenation. Increased circulation improves tissue nutrition and reduces stress. Literature has shown that body temperature decreased in children who received a warm water foot bath. Similarly, studies reported that warm water foot baths were effective in reducing fever in individuals with complaints of high fever.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control
| Arm | Type | Receives |
|---|---|---|
| Application Footbath | Experimental | Other: Application FootbathThe experimental group will then receive the first foot bath with water at 38-40°C for approximately 10 minutes. After this, the second set of physiological parameters will be measured at the 40th minute. The child will rest for 10 minutes, followed by measurement and recording of the third set of parameters at the 50th minute. A second foot bath at 38-40°C will be applied for another 10 minutes. After this, the fourth set of physiological parameters will be measured, and the FLACC pain score (2nd measurement) will be recorded by the same nurse observer and parent at the 60th minute. The procedure will then be terminated. |
| Control Group | No intervention | –Approximately 10 minutes after the application of the antipyretic, the adaptation of the family and the child to the clinic will be awaited. Children and families who meet the sample selection criteria and verbally and in writing agree to participate in the study will be included. A data collection form will be applied to all members of the sample group, and the information will be recorded by the researcher on the form. (20th minute) The parents of the children and the observer nurse will be explained how to use the FLACC pain assessment scale. For inter-observer agreement, the nurse administering the antipyretic and the accompanying parent will simultaneously evaluate using the scale. Throughout the process, the parents of both groups will be with the child. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The child is between 1-5 years old. The child has presented to the emergency department with a fever of 38.3°C or higher.
- The child is a patient with "Green Area" (specific condition or disease). The child has no chronic illness. The child has not used any other antipyretic medication in the last 6 hours.
- The child has been administered 15 mg/kg of oral paracetamol as prescribed by the doctor.
- The child and their parent(s) have volunteered to participate in the study. Written consent from the parent(s) is obtained.
Key exclusion criteria (4 listed)
- Individuals who have not agreed to participate voluntarily in the study.
- Children who have been unable to take paracetamol due to spillage or vomiting.
- Children with compromised skin integrity.
- Individuals who have undergone surgical procedures that would hinder the child's activity.
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 |
|---|---|---|
| Application FootbathThe foot bath application for the experimental group will be applied with water at 38-40 degrees Celsius for an average of 10 minutes under thermometer control. Immediately afterward, the second physiological parameters will be measured. | Other | Application Footbath |
Primary outcome
FLACC SCORE
Time frame: 0 minute
Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain
FLACC SCORE
Time frame: 30 minute
Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain
FLACC SCORE
Time frame: 50 minute
Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain
5 secondary outcomes
Heart Rate
Time frame: 0 minute
Heart Rate
Time frame: 30 minute
Heart Rate
Time frame: 40 minute
Heart Rate
Time frame: 50 minute
Heart Rate
Time frame: 60 minute
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 8 Dec 2025.
- 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.
semin dinç principal investigator
Atlas University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application Footbath in people with Nursing Caries, run by Atlas University at 2 sites 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 4 inclusion and 4 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
FLACC SCORE (time frame: 0 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2025.