Studies on the behavioural effects of fear: pilot study of the effects of inhaled carbon dioxide on subjective emotions and physiological measures in patients with irritable bowel syndrome (IBS)
| ISRCTN | ISRCTN94637457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94637457 |
| Secondary identifying numbers | N0264149443 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 01/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof D J Nutt
Scientific
Scientific
C/O Research & Effectiveness Department
Level 1, The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 928 3473 |
|---|---|
| r&eoffice@ubht.swest.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | To explore whether traditional anxiolytic lorazepam administered orally prior to the procedure can attenuate fear and anxiety. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Irritable bowel syndrome (IBS) |
| Intervention | Single, blind, placebo controlled trial of inhaled carbon dioxide with traditional anxiolytic lorazepam administered orally prior to the procedure. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lorazepam |
| Primary outcome measure | Measurable fear using subjective ratings |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2004 |
| Overall study end date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Sample group: 12 patients with IBS and 12 healthy volunteers |
| Participant inclusion criteria | Patients with irritable bowel syndrome (IBS) |
| Participant exclusion criteria | History of cardiovascular or respiratory disease |
| Recruitment start date | 01/08/2004 |
| Recruitment end date | 01/08/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
United Bristol Healthcare NHS Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No |
