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 |
| Protocol serial number | N0264149443 |
| Sponsor | Department of Health |
| Funders | United Bristol Healthcare NHS Trust (UK), NHS R&D Support Funding (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lorazepam |
| Primary outcome measure(s) |
Measurable fear using subjective ratings |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 24 |
| Key inclusion criteria | Patients with irritable bowel syndrome (IBS) |
| Key exclusion criteria | History of cardiovascular or respiratory disease |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 01/08/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
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? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No |
