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
Secondary identifying numbers N0226111711
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

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)
Email lahoughton@man.ac.uk

Study information

Study designRandomised placebo-controlled crossover study trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA study to investigate the effect of hypnotically induced nausea on gastric emptying rate of a standard meal in normal healthy volunteers
Study objectivesTo 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) studiedNausea
InterventionA 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 typeOther
Primary outcome measureTo determine whether hypnotically induced nausea delays gastric emptying in normal healthy control subjects.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/2002
Completion date21/01/2004

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants8
Key inclusion criteriaEight healthy volunteers determined by detailed medical history, physical examination, electrocardiogram (ECG) and negative pregnancy test.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/05/2002
Date of final enrolment21/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Withington Hospital
Manchester
M20 2LR
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

South Manchester University Hospitals 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

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