Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000528459
Ethics application status
Approved
Date submitted
12/11/2015
Date registered
22/04/2016
Date last updated
22/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized controlled trial comparing knowledge transfer regarding preoperative information to children and parents: Interactive web-based format (Anesthesia Web) vs. conventional brochure information
Scientific title
A randomized controlled trial comparing knowledge transfer regarding preoperative information to children and parents: Interactive web-based format (Anesthesia Web) vs. conventional brochure information
Secondary ID [1] 287757 0
N/A
Universal Trial Number (UTN)
U1111-1176-4809
Trial acronym
AWBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knowledge transfer of preoperative information 296633 0
Condition category
Condition code
Anaesthesiology 296869 296869 0 0
Other anaesthesiology
Surgery 297269 297269 0 0
Other surgery
Public Health 297270 297270 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The goal of this work is to, in a prospective, randomized study, examine whether there are differences in transfer of knowledge between printed and web-based information to children and relatives before anesthesia and surgery.

a). The web-site includes information about the body and how it works, how it is being in hospital and what happens before, during and after anesthesia and surgery.
The system is interactive and contains age-specific information i.e. cartoons, web-books, videos and interviews with children in different ages. The information for children is available in Swedish, English, Spanish and Arabic. The information for adults is available in over 25 different languagues.
b) The information is administred to the families on the pre-anaesthetic meeting 2-3 weeks before the day of surgery.
c) The information for children and parents have the same contains in general but in addition ,for the parents, information is provided about how to prepare the child for the hospital visit, when to talk to them, what to say etc.
d) The information is available and free internet. The families get a card with the web-adress.
e) The web-site contains data about i.e. the number of the visitors’ entries, what specific parts which have visitors, how often and for how long time, country and choice of languages. These data can be seen in trends over the days, seasons and years
Intervention code [1] 293155 0
Other interventions
Comparator / control treatment
Conventional printed brochure information

The information is administred to the families on the pre-anaesthetic meeting 2-3 weeks before the day of surgery.
Control group
Active

Outcomes
Primary outcome [1] 296598 0
Aggregated score by the children regarding answers to control questions at the day of surgery, prior to anesthesia induction.

The questions where designed specifically for this study. Same answers can be found in both medias (webb and broschure).
The questions includes:
1. Knowledge of specific terms often used at the hospital.
2. Fasting procedures iv-procedures
3. Sterile and safety procedures
4. Pain management
Timepoint [1] 296598 0
The questions will be asked prior the anaesthesia induction, on the day of surgery at the ward.
Secondary outcome [1] 318851 0
None
Timepoint [1] 318851 0
n/a

Eligibility
Key inclusion criteria
All children between 3-12 years who are scheduled for outpatient surgery.
Minimum age
3 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children or relatives who cannot understand Swedish, English, Spanish or Arabic. ASA risk class 3 and 4.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The power analysis is based on the ability to detect a 20 % difference in aggregated points of the answers to the preoperative control questions (p < 0.05). The power analysis resulted in the need of a total sample size of 200 patients (100 patients in each group). To handle a greater difference than the expected 20 % an interim analysis is included after a total of 120 patients, when with a requested p-value < 0.02.

Traditional non-parametric statistics will be used to compare the total aggregate points between the two study groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/10/2015
Date of last participant enrolment
Anticipated
2/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 7330 0
Sweden
State/province [1] 7330 0
Stockholm

Funding & Sponsors
Funding source category [1] 292378 0
Government body
Name [1] 292378 0
ALF Avtal om lakarutbildning och forskning
Country [1] 292378 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
Head of Department Inger Mossberg
Paediatric Anaesthesia/Intesive Care/ECMO services
ALB/Karolinska University Hospital-Solna
171 76 Stockholm
Country
Sweden
Secondary sponsor category [1] 291064 0
None
Name [1] 291064 0
None
Address [1] 291064 0
N/A
Country [1] 291064 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293849 0
Region EPN, Stockholm
Ethics committee address [1] 293849 0
Ethics committee country [1] 293849 0
Sweden
Date submitted for ethics approval [1] 293849 0
16/06/2015
Approval date [1] 293849 0
10/08/2015
Ethics approval number [1] 293849 0
EPN 2015/1162-31

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61242 0
Ms Gunilla Loof
Address 61242 0
Department of Paediatric Anaesthesia and Intensive care
Astrid Lindgren Childrens hospital
Karolinska University hospital
171 76 Stockholm
Sweden
Country 61242 0
Sweden
Phone 61242 0
+46-708-624033
Fax 61242 0
+46-8-5177 7265
Email 61242 0
[email protected]
Contact person for public queries
Name 61243 0
Gunilla Loof
Address 61243 0
Department of Paediatric Anaesthesia and Intensive care
Astrid Lindgren Childrens hospital
Karolinska University hospital
171 76 Stockholm
Sweden
Country 61243 0
Sweden
Phone 61243 0
+46-708-624033
Fax 61243 0
+46-8-5177 7265
Email 61243 0
[email protected]
Contact person for scientific queries
Name 61244 0
Gunilla Loof
Address 61244 0
Department of Paediatric Anaesthesia and Intensive care
Astrid Lindgren Childrens hospital
Karolinska University hospital
171 76 Stockholm
Sweden
Country 61244 0
Sweden
Phone 61244 0
+46-708-624033
Fax 61244 0
+46-8-5177 7265
Email 61244 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.