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 design	Randomised placebo-controlled crossover study trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	To determine whether hypnotically induced nausea delays gastric emptying in normal healthy control subjects.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2002
Completion date	21/01/2004

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	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

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 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

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