Clinical trial NCT06537206: Foot Bath on Fever Management in Children (EWWFBFMC)
Official title: Effect of Warm Water Foot Bath on Fever Management in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nursing Caries
Lead sponsor: Atlas University
Sponsor class: OTHER
Collaborators: name: Koç University
First posted: 2024-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sequential Assignment
Primary purpose: SUPPORTIVE_CARE

Brief 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. This study is planned to evaluate the effect of warm water foot baths on vital signs and pain in children and to scientifically examine this effect with 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 health institutions, it constitutes 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 fever or high doses for high fever, repeated use of antipyretics, and inappropriate use of antibiotics lead to ineffective management, causing 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. In a study by Ishita et al. (2017), it was observed that body temperature decreased in children who had a warm water foot bath. Similarly, studies by Sunar (2017) and Retnam and Sophia (2018) reported that warm water foot baths were effective in reducing fever in individuals with complaints of high fever.

Eligibility criteria: Inclusion Criteria:

* 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 "Yeşil alan" (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.

Exclusion Criteria:

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.

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Primary outcomes:
measure: FLACC SCORE
timeFrame: 0 minute
measure: FLACC SCORE
timeFrame: 30 minute
measure: FLACC SCORE
timeFrame: 50 minute
Secondary outcomes:
measure: Heart Rate
timeFrame: 0 minute
measure: Heart Rate
timeFrame: 30 minute
measure: Heart Rate
timeFrame: 40 minute
measure: Heart Rate
timeFrame: 50 minute
measure: Heart Rate
timeFrame: 60 minute
Other outcomes:
measure: Respiration Rate
timeFrame: 0 minute
measure: Respiration Rate
timeFrame: 30 minute
measure: Respiration Rate
timeFrame: 40 minute
measure: Respiration Rate
timeFrame: 50 minute
measure: Respiration Rate
timeFrame: 60 minute
measure: SpO2
timeFrame: 0 minute
measure: SpO2
timeFrame: 30 minute
measure: SpO2
timeFrame: 40 minute
measure: SpO2
timeFrame: 50 minute
measure: SpO2
timeFrame: 60 minute
measure: Fever
timeFrame: 0 minute
measure: Fever
timeFrame: 30 minute
measure: Fever
timeFrame: 40 minute
measure: Fever
timeFrame: 50 minute
measure: Fever
timeFrame: 60 minute
Locations:
Study officials:
affiliation: Atlas University
name: semin dinç
role: PRINCIPAL_INVESTIGATOR
References: