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

ISRCTN ISRCTN69643568
DOI https://doi.org/10.1186/ISRCTN69643568
Secondary identifying numbers N0060131616
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
03/11/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
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 Trottie Kirwan
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePilot 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
Study objectivesDoes 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPain
InterventionShort 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 typeOther
Primary outcome measureImproved pain control and toleration of regular dressing change and debridement of burns with reduced anxiety and awareness.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2003
Completion date30/09/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants10
Key inclusion criteriaMinimum 10 consenting adults suitable to trial criteria and protocols.
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/04/2003
Date of final enrolment30/09/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Chelsea & Westminster Hospital
London
SW10 9NH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

Chelsea and Westminster Healthcare NHS Trust (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