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Completed

NCT Number: NCT06537206

Foot Bath on Fever Management in Children (EWWFBFMC)

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.

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Key information

Conditions

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlas Üniversity, Kağıthane, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 "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.

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.

Treatment and study plan

Application Footbath

Other

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.

Primary outcomes

  1. FLACC SCORE

    Time frame: 0 minute

    Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain

  2. FLACC SCORE

    Time frame: 30 minute

    Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain

  3. FLACC SCORE

    Time frame: 50 minute

    Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain

Secondary outcomes

  1. Heart Rate

    Time frame: 0 minute

    Heart Rate

  2. Heart Rate

    Time frame: 30 minute

    Heart Rate

  3. Heart Rate

    Time frame: 40 minute

    Heart Rate

  4. Heart Rate

    Time frame: 50 minute

    Heart Rate

  5. Heart Rate

    Time frame: 60 minute

    Heart Rate

Other outcomes

  1. Respiration Rate

    Time frame: 0 minute

    Respiration Rates

  2. Respiration Rate

    Time frame: 30 minute

    Respiration Rates

  3. Respiration Rate

    Time frame: 40 minute

    Respiration Rates

  4. Respiration Rate

    Time frame: 50 minute

    Respiration Rates

  5. Respiration Rate

    Time frame: 60 minute

    Respiration Rates

  6. SpO2

    Time frame: 0 minute

    Saturation Level

  7. SpO2

    Time frame: 30 minute

    Saturation Level

  8. SpO2

    Time frame: 40 minute

    Saturation Level

  9. SpO2

    Time frame: 50 minute

    Saturation Level

  10. SpO2

    Time frame: 60 minute

    Saturation Level

  11. Fever

    Time frame: 0 minute

    Body Temparature

  12. Fever

    Time frame: 30 minute

    Body Temparature

  13. Fever

    Time frame: 40 minute

    Body Temparature

  14. Fever

    Time frame: 50 minute

    Body Temparature

  15. Fever

    Time frame: 60 minute

    Body Temparature

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Collaborators

  • Koç University

Registry information

Official study title

Effect of Warm Water Foot Bath on Fever Management in Children: A Randomized Controlled Trial

Acronym: EWWFBFMC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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