Contact information
Type
Scientific
Primary contact
Dr Jean Louis Frossard
ORCID ID
Contact details
Division of Gastroenteorlogy
Geneva University Hospital
Geneve
1211
Switzerland
+41 223 72 93 40
jean-louis.frossard@hcuge.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001/1999
Study information
Scientific title
Acronym
Study hypothesis
To assess the effectiveness of combined written and oral information, compared with oral information alone on the quality of information before endoscopy and the level of anxiety.
Ethics approval
No ethics approval was required for this trial in 1999. There was no specific ethic committee at the Geneva University Hospital at the time but the trial was approved by the Head of the Division of Gastroenteorlogy.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Condition
Gastrointestinal endoscopy
Intervention
Patients randomized either to receiving, along with the appointment notice, an explanatory leaflet about the upcoming examination, or to oral information delivered by each patient's doctor.
The appointment letter was sent to the patient with or without the written information leaflet within one week before endoscopy for most participants. Patient consent to participate was obtained only upon his arrival for the endoscopic procedure.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Evaluation of quality of information rated on scales between 0 (none received) and 5 (excellent), assessed immediately after the endoscopy
Secondary outcome measures
Patients rated the following, using a questionnaire to be filled within 24 hours and sent back by mail in a prepaid envelope:
1. Their anxiety at the time of the procedure (between none and strong)
2. How tolerable the procedure was (between very easy and very hard)
3. Their pain during the procedure (between none and strong)
4. Whether any health problems occurred as a result of the procedure (none, minor, moderate or severe)
5. The procedure as a whole (between poor and excellent)
Overall trial start date
01/01/1999
Overall trial end date
01/04/1999
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients scheduled for an elective digestive endoscopy (upper gastrointestinal endoscopy or colonoscopy) within three months
2. Resident in Switzerland
3. Understand French language
4. Able to fill in the study questionnaire
Note: Both inpatients and outpatients were included
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
800
Participant exclusion criteria
1. Age <18 years
2. Pregnancy
3. Patients unable to give their own consent
4. Patients that had already undergone prior endoscopy
Recruitment start date
01/01/1999
Recruitment end date
01/04/1999
Locations
Countries of recruitment
Switzerland
Trial participating centre
Division of Gastroenteorlogy
Geneve
1211
Switzerland
Sponsor information
Organisation
Geneva University Hospital (Switzerland)
Sponsor details
Rue Micheli du Crest
Geneve
1211
Switzerland
+41 22 372 93 40
jean-louis.frossard@hcuge.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
This trial was internally funded by the Geneva University Hospital (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary