Foot Bath on Fever Management in Children (EWWFBFMC)

NCT06537206 | Completed

• 1 other identifier: E-2268639050.99-46589
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Nursing Caries

Outcome Measures

Primary Outcomes (3)

• FLACC SCORE

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

  0 minute

• FLACC SCORE

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

  30 minute

• FLACC SCORE

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

  50 minute

Secondary Outcomes (5)

• Heart Rate

  0 minute

• Heart Rate

  30 minute

• Heart Rate

  40 minute

• Heart Rate

  50 minute

• Heart Rate

  60 minute

Other Outcomes (15)

• Respiration Rate

  0 minute

• Respiration Rate

  30 minute

• Respiration Rate

  40 minute

Study Arms (2)

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.

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.

Interventions

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.

Application Footbath

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atlas University: lead
• Koç University: collaborator

Study Sites (2)

Atlas Üniversity

Kağıthane, Istanbul, 34098, Turkey (Türkiye)

Location

Atlas University

Kâğıthane, Istanbul, 34098, Turkey (Türkiye)

Location

Study Officials

• semin dinç

  Atlas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized control

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: August 30, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 8, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)