Condition category
Surgery
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
14/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

No publication intended as of 14/01/10

Publication citations

Additional files

Editorial Notes