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

ISRCTN ISRCTN86133721
DOI https://doi.org/10.1186/ISRCTN86133721
Secondary identifying numbers C/N/12/10-01-95/SMITH/D
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
21/11/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific titleA randomised controlled trial of a pre-assessment clinic for paediatric general surgery day cases
Study objectivesThe 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) studiedPaediatric surgery
Intervention1. Information given on the day of admission
1. Information given at the preassessment clinic before admission
Intervention typeProcedure/Surgery
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date18/09/1995
Completion date31/03/1999

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaChildren listed for day case surgery at Bristol Children's Hospital.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment18/09/1995
Date of final enrolment31/03/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South West (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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