- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01659879
Multimedia Based Information to Parents in a Pediatric Acute Ward: A Randomized Controlled Trial
December 28, 2023 updated by: Norwegian University of Science and Technology
The aim of this study is to determine whether multimedia based health information presented in a pediatric acute ward to parents of children with breathing difficulties due to lower respiratory tract infections, is more effective than verbal information to reduce the parent's anxiety and to increase satisfaction with nursing care and health information.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The intervention website www.syktbarn.no is an open Norwegian online resource for parents of small children, and the site contains videos, audio clips, animations, illustrations, pictures and text materials regarding children's illnesses and normal development.
In addition, the parents can use an interactive symptom checker that will help them to decide what to do and when to seek medical advice when their child is sick.
The uniqueness of the website is the authentic video clips of sick children with common childhood symptoms like breathing difficulties, signs of dehydration, rash, cough and fever.
Study Type
Interventional
Enrollment (Actual)
101
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
-
-
-
Trondheim, Norway
- Department of Pediatrics, St. Olav's University 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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- parents of 0-15 years old children with breathing difficulties caused by LRTI (bronchiolitis, laryngitis or pneumonia) or asthma exacerbation
- ability to communicate and read Norwegian
Exclusion Criteria:
- parents of children with chronic diseases who have direct access to the acute ward, children with oxygen saturation less than 90 %, or other very sick children who need urgent treatment
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: multimedia information
Health information concerning the child's diagnosis, treatment and recovery time after evaluation by the pediatrician, using a 15 minutes long standardized health information package with multimedia elements from the Norwegian website www.syktbarn.no
(English version: www.childhealthguide.com)
|
|
Active Comparator: verbal information
Verbal health information by a nurse in the acute ward concerning the child's diagnosis, treatment and recovery time, after the evaluation by the pediatrician
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
parental anxiety
Time Frame: at discharge from the acute ward. An average stay in the acute ward is about 5 hours.
|
evaluated with the State-Trait Anxiety Inventory (STAI) (translated to Norwegian)
|
at discharge from the acute ward. An average stay in the acute ward is about 5 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
parental satisfaction with nursing care
Time Frame: at discharge from the acute ward. An average stay in the acute ward is about 5 hours.
|
evaluated with the Consumer Emergency Care Satisfaction Scale (CECSS)
|
at discharge from the acute ward. An average stay in the acute ward is about 5 hours.
|
Parental satisfaction with the health information given in the acute ward.
Time Frame: 1-2 weeks after discharge from the hospital. An average stay in the acute ward is about 5 hours, and an average stay in the children's department is 2 days.
|
Evaluated with a structured telephone interview 1-2 weeks after hospital discharge, performed by the main researcher.
|
1-2 weeks after discharge from the hospital. An average stay in the acute ward is about 5 hours, and an average stay in the children's department is 2 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Jon Skranes, MD, PhD, Norwegian University of Science and Technology
- Principal Investigator: Henrik Døllner, MD, PhD, St. Olavs Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
- an open online resource in Norwegian for parents of small children, containing videos, audio clips, animations, illustrations, pictures and text materials regarding children's illnesses and normal development
- an open online resource for parents of small children, containing videos, audio clips, animations, illustrations, pictures and text materials regarding children's illnesses and normal development
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
January 1, 2011
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
August 2, 2012
First Submitted That Met QC Criteria
August 3, 2012
First Posted (Estimated)
August 8, 2012
Study Record Updates
Last Update Posted (Actual)
December 29, 2023
Last Update Submitted That Met QC Criteria
December 28, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LBK-2010/12-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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