A randomised controlled trial of a pre-assessment clinic for paediatric general surgery day cases

ISRCTN	ISRCTN86133721
DOI	https://doi.org/10.1186/ISRCTN86133721
Protocol serial number	C/N/12/10-01-95/SMITH/D
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South West (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Ian Harvey
Scientific

University of East Anglia
School of Health, Policy and Practice
Norwich
NR4 7TJ
United Kingdom

Phone	+44 (0)1603 456161
Email	ian.harvey@uea.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of a pre-assessment clinic for paediatric general surgery day cases
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Paediatric surgery
Intervention	1. Information given on the day of admission 1. Information given at the preassessment clinic before admission
Intervention type	Procedure/Surgery
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/1999

Participant type(s)	Patient
Age group	Child
Sex	All
Key inclusion criteria	Children listed for day case surgery at Bristol Children's Hospital.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	18/09/1995
Date of final enrolment	31/03/1999

University of East Anglia

Norwich
NR4 7TJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

21/11/2019: No publications found. Verifying results with principal investigator.