Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/04/2016
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 R Lwin

ORCID ID

Contact details

Paediatric Liaison
Mulberry House
Royal Liverpool Children's NHS Trust
Liverpool
L12 2AP
United Kingdom
+44 (0)161 613 7077
rebekah.lwin@alderhey.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0206114330

Study information

Scientific title

An evaluation of a hospital information and skills training video for the preparation of children waiting for day surgery

Acronym

Study hypothesis

To establish whether a video-based pre-admission distance learning pack is more effective than standard hospital preparation leaflets alone in reducing anxiety to imminent planned surgery in children and their parents/carers? To establish if the video reduces anxiety and self-reported pain in children who have recently had planned surgery and their parents? To establish if the video is a user friendly and accessible method or pre-surgery preparation?

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Paediatric surgery

Intervention

Prospective, randomised, comparative study.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Self reported child fearfulness and anxiety pre and post surgery.
2. Self reported parent/carer anxiety pre and post surgery.
3. Self reported child post operative pain.
4. Adult reported child post operative pain.
All measures are questionnaires.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2002

Overall trial end date

31/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All parents of children awaiting planned surgery on the booked admissions programmed at AH. Male/female aged between 6 and 11 years of age.

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/11/2002

Recruitment end date

31/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool Children's NHS Trust
Liverpool
L12 2AP
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Liverpool Children's NHS Trust (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

Publication citations

Additional files

Editorial Notes

18/04/2016: No publications found, verifying study status with principal investigator