- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06043479
Evaluation of the Effectiveness of the Training Given to Mothers With 0-5 Age Group Children for Fire Management
September 15, 2023 updated by: Demet Yıldırım, Okan University
The research was conducted in a randomized controlled design to evaluate the effectiveness of the fever management training given to mothers of children aged 0-5.
Study Overview
Detailed Description
The research was conducted between January 2023 and April 2023 in the Pediatric Ward of Gebze Fatih State Hospital.
The study included 120 mothers, with 60 in the intervention group and 60 in the control group, who had children aged 0-5 years old admitted to the hospital with a complaint of fever.
The data was collected using the 'Mother and Child Information Form,' 'Parent's Fever Management Scale (PFMS),' 'Fever Management Knowledge Statements Form (FMKSF),' and 'Follow-up Form.
The data were analyzed using appropriate statistical methods in the SPSS (Statistical Package for Social Sciences) for Windows 26.0 software package.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kocaeli̇
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Gebze, Kocaeli̇, Turkey, 41400
- .Demet Yildirim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Mothers with 0-5 age group children in fever
- Must be literate
Exclusion Criteria:
- Discharge before 3 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
The mothers were provided with a three-day training consisting of six sessions.
Two sessions were held each day, with each session lasting for 30 minutes.
|
The mothers were provided with a three-day training consisting of six sessions.
Two sessions were held each day, with each session lasting for 30 minutes.
|
|
No Intervention: Control group
Routine practices continued for the mothers for three days without providing any training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mother and Child Information Form
Time Frame: baseline
|
The form was prepared by the researchers based on a literature review.
It consists of 7 questions about the demographic characteristics of mothers and their children aged 0-5 years and mothers' fever management.
|
baseline
|
|
The Parent Fever Management Scale (PFMS)
Time Frame: baseline and 3 days and 1 month
|
The scale was developed by Walsh and colleagues (2008), aims to assess what parents do when their child's temperature rises.
Its validity and reliability have been established by Cinar et al. (2014).
The scale consists of 8 items, and scores can range from 8 to 40.
Higher scores on the scale indicate that parents engage in more fever management practices and have more concerns, fever phobia, and parental burden related to fever.
|
baseline and 3 days and 1 month
|
|
The Fever Management Knowledge Statements Form
Time Frame: baseline and 3 days and 1 month
|
The form is a set of 25 statements developed by researchers to measure mothers' knowledge about fever management.
These statements were created by reviewing the literature.
Afterward, the statements were refined based on the input from five experts.
|
baseline and 3 days and 1 month
|
|
The Follow-up Form
Time Frame: through study completion, an average of 3 month
|
The form was created by the researchers to track the participants' scores from the pre-test and post-test throughout the study.
|
through study completion, an average of 3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nadiye Barış Eren, Tarsus University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
April 30, 2023
Study Completion (Actual)
April 30, 2023
Study Registration Dates
First Submitted
June 21, 2023
First Submitted That Met QC Criteria
September 15, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 15, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Okan Uni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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