Written versus verbal patient information before gastrointestinal endoscopy: a randomized trial
| ISRCTN | ISRCTN34382782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34382782 |
| Protocol serial number | 001/1999 |
| Sponsor | Geneva University Hospital (Switzerland) |
| Funder | This trial was internally funded by the Geneva University Hospital (Switzerland) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Division of Gastroenteorlogy
Geneva University Hospital
Geneve
1211
Switzerland
| Phone | +41 223 72 93 40 |
|---|---|
| jean-louis.frossard@hcuge.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Evaluation of quality of information rated on scales between 0 (none received) and 5 (excellent), assessed immediately after the endoscopy |
| Key secondary outcome measure(s) |
Patients rated the following, using a questionnaire to be filled within 24 hours and sent back by mail in a prepaid envelope: |
| Completion date | 01/04/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
1211
Switzerland
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? |
|---|---|---|---|---|---|
| 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.
