Video and Brochure and Discharge Instructions for Childhood Fever in the Pediatric Emergency Department

September 3, 2023 updated by: Aylin Kurt, Bartın Unıversity
This study was designed to evaluate whether adding Video discharge instructions to usual verbal information improves understanding of the information provided to caregivers of patients presenting to pediatric emergency departments for high fever. As secondary goals, it was aimed to assess whether video discharge instructions increase satisfaction with information received and reduce repeat visits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The research will be carried out in a randomized controlled manner. There will be three groups in the research: those who received video (intervention), brochure (intervention) and verbal (control) discharge instructions. A power analysis was performed based on the number of children in both groups, in another study in which the scales to be used in the research were used. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 48 cases in each group would be sufficient for 80% power. Children who meet the research criteria will be assigned a random number to the intervention and control groups via http://www.randomize.org/ by numbering the order of arrival at the hospital. Research data will be collected using Descriptive Information Form and Parental Fever Management Scale and Post-Discharge Data Collection Form.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Bartın, Turkey, 74100
        • Bartin Maternity and Pediatrics Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The child is between 1 month and 18 years old
  • Parent's consent to participate in the research
  • Parent's completion of all pre-and post-education follow-up

Exclusion Criteria:

  • The child is not between 1 month and 18 years old
  • The child does not undergo day surgery.
  • Parent's refusal to participate in the research
  • Parent not completing all pre- and post-education follow-up

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: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: discharge instructions with video
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups. Before parents in the control group are discharged from the pediatric emergency service, a short 2-minute video will be shown to the American Academy of Pediatrics (2020) guidelines (intervention group with video) giving the same information about high fever to patients in addition to the verbal instructions. Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups. All patients will also receive a discharge report with instructions on post-treatment treatment.
Other: discharge instructions with video
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups. Before parents in the control group are discharged from the pediatric emergency service, a short 2-minute video will be shown to the American Academy of Pediatrics (2020) guidelines (intervention group with video) giving the same information about high fever to patients in addition to the verbal instructions. Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups. All patients will also receive a discharge report with instructions on post-treatment treatment.
Placebo Comparator: verbal discharge instructions only
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups. Parents in the control group will receive the usual verbal information and advice on high fever management in accordance with the guidelines of the American Academy of Pediatrics (2020) prior to discharge from the pediatric emergency service. Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups. All patients will also receive a discharge report with instructions on post-treatment treatment.
Other: verbal discharge instructions only
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups. Parents in the control group will receive the usual verbal information and advice on high fever management in accordance with the guidelines of the American Academy of Pediatrics (2020) prior to discharge from the pediatric emergency service. Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups. All patients will also receive a discharge report with instructions on post-treatment treatment.
Experimental: discharge instructions with pamphlet
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups. Before the parents in the control group are discharged from the pediatric emergency service, in the second group (intervention group with brochure) in accordance with the guidelines of the American Academy of Pediatrics (2020), the parents will be told with the brochure giving the same information about fever in addition to the verbal instructions. Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups. All patients will also receive a discharge report with instructions on post-treatment treatment.
Other: discharge instructions with pamphlet
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups. Before the parents in the control group are discharged from the pediatric emergency service, in the second group (intervention group with brochure) in accordance with the guidelines of the American Academy of Pediatrics (2020), the parents will be told with the brochure giving the same information about fever in addition to the verbal instructions. Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups. All patients will also receive a discharge report with instructions on post-treatment treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The parents in the groups who received discharge instructions with a video and brochure, three days later, had a lower "Parental Fever Management Scale" score average than the control group.
Time Frame: 3 days
As a result of the answers given to the scale, the total score varies between 8 and 40. The increase in the total score of the scale indicates that parents developed high anxiety and fever phobia during the care of their children's febrile illnesses.
3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The parents in the groups who received discharge instructions with a video and brochure, after three days, had higher scores on the "Fever Management Approach Scale" compared to the control group.
Time Frame: 3 days
The scores that the participants can get vary between 6-36. Evaluation is defined as the participants with a score below 21 approaching the fire with fear, while the participants with a score above 20 contribute to fever management in children with a functional approach. Parents who receive discharge instructions with videos and brochures are expected to have an average score above 20.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bartın Unıversity

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-SBB-0645

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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