A study to investigate the effect of hypnotically induced nausea on gastric emptying rate of a standard meal in normal healthy volunteers
| ISRCTN | ISRCTN66392513 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66392513 |
| Protocol serial number | N0226111711 |
| Sponsor | Department of Health (UK) |
| Funder | South Manchester University Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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 Lesley A Houghton
Scientific
Scientific
University Department of Medicine
South Manchester University Hospitals NHS Trust
Withington Hospital
Nell Lane
Manchester
M20 2LR
United Kingdom
| Phone | +44 (0)161 291 4020/5813 (sec) |
|---|---|
| lahoughton@man.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled crossover study trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | A study to investigate the effect of hypnotically induced nausea on gastric emptying rate of a standard meal in normal healthy volunteers |
| Study objectives | To assess the effect of hypnotically induced nausea on gastric emptying rate of a standard meal in normal healthy volunteers and to validate a new technique for the induction of nausea in a laboratory setting. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nausea |
| Intervention | A randomised, placebo controlled crossover study design will be used - each subject will have their gastric emptying rate assessed on one visit in the control state and following hypnotic induction of nausea on the other. |
| Intervention type | Other |
| Primary outcome measure(s) |
To determine whether hypnotically induced nausea delays gastric emptying in normal healthy control subjects. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 21/01/2004 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 8 |
| Key inclusion criteria | Eight healthy volunteers determined by detailed medical history, physical examination, electrocardiogram (ECG) and negative pregnancy test. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/05/2002 |
| Date of final enrolment | 21/01/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Withington Hospital
Manchester
M20 2LR
United Kingdom
M20 2LR
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 |
Editorial Notes
16/04/2018: No publications found, verifying study status with principal investigator
14/03/2016: No publications found, verifying study status with principal investigator
