Contact information
Type
Scientific
Primary contact
Dr Ian Harvey
ORCID ID
Contact details
University of East Anglia
School of Health
Policy and Practice
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 456161
ian.harvey@uea.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C/N/12/10-01-95/SMITH/D
Study information
Scientific title
A randomised controlled trial of a pre-assessment clinic for paediatric general surgery day cases
Acronym
Study hypothesis
The aim of this study was to compare two methods of preparing children and their parents for day case surgery. The two methods that were compared were providing information on the day of surgery (previous practice) versus providing information before admission at a pre-assessment clinic.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Paediatric surgery
Intervention
1. Information given on the day of admission
1. Information given at the preassessment clinic before admission
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
1. Behavioural distress of the child around the time of the surgery
2. Behavioural disturbance of the child immediately after discharge from hospital and 4 months later
2.1. Vernon post-hospital behaviour scale
2.2. Rowe behavioural rating inventory
3. Likert-scale anxiety ratings of parent and child during the admission (completed by the parent prior to discharge)
4. Compliance of parents with home care instructions
Secondary outcome measures
Not provided at time of registration
Overall trial start date
18/09/1995
Overall trial end date
31/03/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children listed for day case surgery at Bristol Children's Hospital.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
18/09/1995
Recruitment end date
31/03/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South West (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
No publication intended as of 14/01/10