Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
03/11/2015
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 Trottie Kirwan

ORCID ID

Contact details

Dept of Anaesthetics
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0060131616

Study information

Scientific title

Pilot study to assess the feasibility and patient numbers required prior to a randomised controlled trial of the effect of visual distraction for painful procedures in the burns unit

Acronym

Study hypothesis

Does the use of 2D video glasses with DVD film images and stereo sound during dressing changes for patients with burns decrease the intensity of their experience of pain and anxiety?

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

Treatment

Patient information sheet

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

Condition

Pain

Intervention

Short visual analogue scale patient rated scores for pain and anxiety, an appropriate questionnaire and short concluding taped interview after intervention. Quantitative methods will be used.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Improved pain control and toleration of regular dressing change and debridement of burns with reduced anxiety and awareness.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Minimum 10 consenting adults suitable to trial criteria and protocols.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2003

Recruitment end date

30/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Chelsea & Westminster Hospital
London
SW10 9NH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Chelsea and Westminster Healthcare 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