FeverNCT06043479
Evaluation of the Effectiveness of the Training Given to Mothers With 0-5 Age Group Children for Fire Management
A study testing Fever Management Education in people with Fever, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fever
- What is being tested?
- Fever Management Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers with 0-5 age group children in fever
- Must be literate
Who cannot join
- Discharge before 3 days
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fever
- Being tested
- Fever Management Education
- Keywords
- Child, fever,, mother,, fever management,, education
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fever Management EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Fever Management Education |
| Control group | No intervention | Routine practices continued for the mothers for three days without providing any training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother and Child Information Form
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.
Measured: baseline
The Parent Fever Management Scale (PFMS)
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.
Measured: baseline and 3 days and 1 month
The Fever Management Knowledge Statements Form
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.
Measured: baseline and 3 days and 1 month
The Follow-up Form
The form was created by the researchers to track the participants' scores from the pre-test and post-test throughout the study.
Measured: through study completion, an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jan 2023
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control group and intervention group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Yıldırım, Okan University
- Investigators
- Nadiye Barış Eren, Study director, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043479
- Sponsor's protocol ID
- Okan Uni
- Status last verified
- Sep 2023
- First submitted
- 21 Jun 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Training Given to Mothers With 0-5 Age Group Children for Fire Management
- ClinicalTrials.gov ID
- NCT06043479
- Acronym / sponsor ID
- Okan Uni
- Conditions
- Fever
- Keywords
- Child, fever,, mother,, fever management,, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control group and intervention group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Fever Management EducationThe 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. |
| Control group | No intervention | –Routine practices continued for the mothers for three days without providing any training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mothers with 0-5 age group children in fever
- Must be literate
Key exclusion criteria (1 listed)
- Discharge before 3 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fever Management EducationThe 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. | Other | Intervention group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadiye Barış Eren study director
Tarsus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fever Management Education in people with Fever, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother and Child Information Form (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.