Back to resultsVideo and Brochure and Discharge Instructions for Childhood Fever in the Pediatric Emergency Department
Primary Purpose
Fever, Child, Only
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
discharge instructions with pamphlet
discharge instructions with video
verbal discharge instructions only
Sponsored by
About this trial
This is an interventional other trial for Fever
Eligibility Criteria
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
Sites / Locations
- Bartin Maternity and Pediatrics Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
discharge instructions with video
verbal discharge instructions only
discharge instructions with pamphlet
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05929131
Brief Title
Video and Brochure and Discharge Instructions for Childhood Fever in the Pediatric Emergency Department
Official Title
Video and Brochure and Discharge Instructions for Childhood Fever in the Pediatric Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bartın Unıversity
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Child, Only
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
discharge instructions with video
Arm Type
Experimental
Arm Description
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.
Arm Title
verbal discharge instructions only
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
discharge instructions with pamphlet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
discharge instructions with pamphlet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
discharge instructions with video
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
verbal discharge instructions only
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Bartin Maternity and Pediatrics Hospital
City
Bartın
ZIP/Postal Code
74100
Country
Turkey
12. IPD Sharing Statement
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Video and Brochure and Discharge Instructions for Childhood Fever in the Pediatric Emergency Department
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