Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-29 @ 4:59 AM
Study NCT ID:
NCT06537206
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2024-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foot Bath on Fever Management in Children (EWWFBFMC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Respiration Rate', 'timeFrame': '0 minute', 'description': 'Respiration Rates'}, {'measure': 'Respiration Rate', 'timeFrame': '30 minute', 'description': 'Respiration Rates'}, {'measure': 'Respiration Rate', 'timeFrame': '40 minute', 'description': 'Respiration Rates'}, {'measure': 'Respiration Rate', 'timeFrame': '50 minute', 'description': 'Respiration Rates'}, {'measure': 'Respiration Rate', 'timeFrame': '60 minute', 'description': 'Respiration Rates'}, {'measure': 'SpO2', 'timeFrame': '0 minute', 'description': 'Saturation Level'}, {'measure': 'SpO2', 'timeFrame': '30 minute', 'description': 'Saturation Level'}, {'measure': 'SpO2', 'timeFrame': '40 minute', 'description': 'Saturation Level'}, {'measure': 'SpO2', 'timeFrame': '50 minute', 'description': 'Saturation Level'}, {'measure': 'SpO2', 'timeFrame': '60 minute', 'description': 'Saturation Level'}, {'measure': 'Fever', 'timeFrame': '0 minute', 'description': 'Body Temparature'}, {'measure': 'Fever', 'timeFrame': '30 minute', 'description': 'Body Temparature'}, {'measure': 'Fever', 'timeFrame': '40 minute', 'description': 'Body Temparature'}, {'measure': 'Fever', 'timeFrame': '50 minute', 'description': 'Body Temparature'}, {'measure': 'Fever', 'timeFrame': '60 minute', 'description': 'Body Temparature'}], 'primaryOutcomes': [{'measure': 'FLACC SCORE', 'timeFrame': '0 minute', 'description': 'Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain'}, {'measure': 'FLACC SCORE', 'timeFrame': '30 minute', 'description': 'Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain'}, {'measure': 'FLACC SCORE', 'timeFrame': '50 minute', 'description': 'Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain'}], 'secondaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': '0 minute', 'description': 'Heart Rate'}, {'measure': 'Heart Rate', 'timeFrame': '30 minute', 'description': 'Heart Rate'}, {'measure': 'Heart Rate', 'timeFrame': '40 minute', 'description': 'Heart Rate'}, {'measure': 'Heart Rate', 'timeFrame': '50 minute', 'description': 'Heart Rate'}, {'measure': 'Heart Rate', 'timeFrame': '60 minute', 'description': 'Heart Rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nursing Caries']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n* The child has been administered 15 mg/kg of oral paracetamol as prescribed by the doctor.\n* The child and their parent(s) have volunteered to participate in the study. Written consent from the parent(s) is obtained.\n\nExclusion Criteria:\n\n* Individuals who have not agreed to participate voluntarily in the study.\n* Children who have been unable to take paracetamol due to spillage or vomiting.\n* Children with compromised skin integrity.\n* Individuals who have undergone surgical procedures that would hinder the child\'s activity.'}, 'identificationModule': {'nctId': 'NCT06537206', 'acronym': 'EWWFBFMC', 'briefTitle': 'Foot Bath on Fever Management in Children (EWWFBFMC)', 'organization': {'class': 'OTHER', 'fullName': 'Atlas University'}, 'officialTitle': 'Effect of Warm Water Foot Bath on Fever Management in Children: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'E-2268639050.99-46589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Application Footbath', 'description': '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.\n\nA 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.', 'interventionNames': ['Other: Application Footbath']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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.\n\nA 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': [{'name': 'Application Footbath', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Application Footbath']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Kağıthane', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Atlas Üniversity'}, {'zip': '34098', 'city': 'Kâğıthane', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Atlas University', 'geoPoint': {'lat': 41.07944, 'lon': 28.96472}}], 'overallOfficials': [{'name': 'semin dinç', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlas University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlas University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Koç University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sermin Dinc', 'investigatorAffiliation': 'Atlas University'}}}}