Written versus verbal patient information before gastrointestinal endoscopy: a randomized trial

ISRCTN	ISRCTN34382782
DOI	https://doi.org/10.1186/ISRCTN34382782
Secondary identifying numbers	001/1999

Submission date: 11/02/2008
Registration date: 26/02/2008
Last edited: 30/12/2020

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

Dr Jean Louis Frossard
Scientific

Division of Gastroenteorlogy
Geneva University Hospital
Geneve
1211
Switzerland

Phone	+41 223 72 93 40
Email	jean-louis.frossard@hcuge.ch

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Other
Scientific title	Written versus verbal patient information before gastrointestinal endoscopy: a randomized trial
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/1999
Completion date	01/04/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	800
Total final enrolment	577
Key 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
Key exclusion criteria	1. Age <18 years 2. Pregnancy 3. Patients unable to give their own consent 4. Patients that had already undergone prior endoscopy
Date of first enrolment	01/01/1999
Date of final enrolment	01/04/1999

Locations

Countries of recruitment

Switzerland

Study participating centre

Division of Gastroenteorlogy

Geneve
1211
Switzerland

Sponsor information

Geneva University Hospital (Switzerland)
Hospital/treatment centre

Rue Micheli du Crest
Geneve
1211
Switzerland

Phone	+41 22 372 93 40
Email	jean-louis.frossard@hcuge.ch
Website	http://www.hug-ge.ch
"ROR"	https://ror.org/01m1pv723

Funders

Funder type

Hospital/treatment centre

This trial was internally funded by the Geneva University Hospital (Switzerland)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/06/2008	30/12/2020	Yes	No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.