NCT06043479

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

June 21, 2023

Last Update Submit

September 15, 2023

Conditions

Keywords

Childfever,mother,fever management,education

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    through study completion, an average of 3 month

Study Arms (2)

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.

Other: Fever Management Education

Control group

NO INTERVENTION

Routine practices continued for the mothers for three days without providing any training.

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers with 0-5 age group children in fever
  • Must be literate

You may not qualify if:

  • Discharge before 3 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

.Demet Yildirim

Gebze, Kocaeli̇, 41400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nadiye Barış Eren

    Tarsus University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: control group and intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

June 21, 2023

First Posted

September 21, 2023

Study Start

January 1, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations