NCT06599853

Brief Summary

Fever is a common symptom of childhood, especially between the ages of one and five, and is the main reason for emergency room visits. These emergency room visits are due to parents incorrect information and practices regarding fever management. This situation causes an increase in parental anxiety and failure to provide fever management. In line with this information, this study was planned to evaluate the effects of education given to parents of children presenting to the emergency room with fever on parental anxiety level and fever management.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 9, 2024

Last Update Submit

September 17, 2024

Conditions

Keywords

EmergencyFeverParentsEducationChildAnxiety

Outcome Measures

Primary Outcomes (3)

  • Introductory Information Form

    This form was prepared by the researcher in line with the literature. This form consists of three sections. The parent sociodemographic form, the child sociodemographic form and the form, which includes questions on parental fever-related knowledge and practices, consists of a total of 35 questions.

    one months

  • State/Trait Anxiety Inventory (SAI)

    The scale was developed by Spielber and others in 1964 to determine anxiety levels. The Turkish validity and reliability of the scale was carried out by Öner and Le Compte in 1985. The scale provides information about what is felt at that moment and consists of 20 items in Likert type, scored from 1 to 4. 1 is not at all, 2 is a little, 3 is very much and 4 is completely agree, and the individual marks one of these. A value of 1 indicates high anxiety, while a value of 4 indicates low anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 in the SAI are reversed. When calculating the scale score, the total score of the reversed items is subtracted from the total of the correct statements and a fixed score of 50 is added to this number. The total score obtained from the scale varies between 20 and 80. As the score increases, it indicates that anxiety is high, and as the score decreases, it indicates that anxiety decreases.

    one months

  • Parental Fever Management Scale-Turkish Version (PFMS-TR)

    The scale was developed by Walsh and Edwards in 2008 to assess parents' fever management practices. The Turkish validity and reliability of the scale was conducted by Cınar et al. in 2013. The scale consists of 8 items and is a Likert-type scale with items rated as "(1) never, (2) rarely, (3) sometimes, (4) often, (5) always". The lowest possible score for the scale is 8 and the highest is 40. A higher score indicates more fever management practices, and a lower score indicates less fever management practices. The Cronbach Alpha reliability coefficient of the scale is 0.75.

    one months

Secondary Outcomes (5)

  • State/Trait Anxiety Inventory (SAI)

    three months

  • Visual Analog Scale (VAS) - Satisfaction Scale for Fire Education Application

    three months

  • Parental Fever Management Scale-Turkish Version (PFMS-TR)

    three months

  • Parental Fever Management Scale-Turkish Version (PFMS-TR)

    two months

  • State/Trait Anxiety Inventory (SAI)

    two months

Study Arms (2)

Group to be trained

EXPERIMENTAL

Parents in the experimental group were randomly assigned. Parents in the experimental group will be trained with parent fever management training material via home visits. Repeated measurements will be made one month after the training and at 3 months. Parent fever management training material was created by the researcher according to the literature. Opinions of experts in the field were obtained for the suitability of the training booklet.

Other: Fever Education

Control group

NO INTERVENTION

No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group.

Interventions

Another aspect of this research that is different from other studies is that a retention test will be applied to the participants after the pre-test and post-test, and the long-term effect of the training given will be examined. In this direction, it is aimed to reduce the inappropriate use of emergency services, the use of unnecessary tests and the increasing health system costs. It is aimed to prevent crowding in the emergency department by reducing the inappropriate use of emergency services.

Also known as: It is planned to conduct a survey with the first post-test and a retention test 3 months after the training is given to the parents.
Group to be trained

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having a child between the ages of 1-5
  • Able to read, understand and have no problems speaking Turkish
  • Having a green triage code in the emergency room triage application

You may not qualify if:

  • Children diagnosed with or receiving treatment for chronic diseases
  • Children with a history of febrile convulsions
  • Children dependent on home mechanical ventilation
  • Parents with psychiatric diagnoses will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Karadeniz Technical University Faculty of Medicine Pediatric Emergency Unit

Trabzon, Kanuni Campus, 61080, Turkey (Türkiye)

RECRUITING

Karadeniz Technical University Faculty of Medicine Pediatric Emergency Unit

Trabzon, 61080, Turkey (Türkiye)

RECRUITING

Karadeniz Technical University Faculty of Medicine Pediatric Emergency Unit

Trabzon, 61080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

FeverEmergenciesAnxiety Disorders

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesMental Disorders

Study Officials

  • Merve YETİMOĞLU, Nursing

    Karadeniz Technical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

merve yetimoğlu, Nursing

CONTACT

Hacer KOBYA BULUT, Doç. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The research was planned as a randomized controlled study with experimental and control groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nursing

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

April 1, 2024

Primary Completion

September 30, 2024

Study Completion

November 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations