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 |
| Protocol serial number | N0060131616 |
| Sponsor | Department of Health |
| Funder | Chelsea and Westminster Healthcare NHS Trust (UK) |
- 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
Scientific
Dept of Anaesthetics
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Improved pain control and toleration of regular dressing change and debridement of burns with reduced anxiety and awareness. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 10 |
| Key inclusion criteria | Minimum 10 consenting adults suitable to trial criteria and protocols. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Chelsea & Westminster Hospital
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
