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ISRCTN
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ISRCTN86133721
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of a pre-assessment clinic for paediatric general surgery day cases
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Scientific title
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Acronym
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N/A
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Serial number at source
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C/N/12/10-01-95/SMITH/D
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Paediatric surgery
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Participants - inclusion criteria
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Children listed for day case surgery at Bristol Children's Hospital.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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18/09/1995
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Anticipated end date
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31/03/1999
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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1. Information given on the day of admission
1. Information given at the preassessment clinic before admission
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive South West (UK)
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Trial website
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Publications
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No publication intended as of 14/01/10
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Contact name
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Dr
Ian
Harvey
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Address
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University of East Anglia
School of Health, Policy and Practice
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City/town
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Norwich
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Zip/Postcode
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NR4 7TJ
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Country
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United Kingdom
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Tel
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+44 (0)1603 456161
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Email
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ian.harvey@uea.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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14/01/2010
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Date ISRCTN assigned
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23/01/2004
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