Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02977767
Brief Summary:
Tracheotomy is requested when upper aero-digestive tracts are obstructed. This obstruction can have a tumour, infectious, inflammatory, traumatic or nervous origin. Most tracheotomy surgeries are performed for tumour-induced obstruction. Tracheotomy allows the setting of a respiratory flux thanks to a cannula and excludes the upper airways. The cannula is washed every day from once to several times depending on the patient's secretions production and it is usually replaced every week. The second replacement takes place about 10 days after surgery. Patient education takes place at every replacement in order to empower him/her and in consequence to increase living comfort. This empowerment is achieved at the 4th or 5th replacement, at best. Because of the risks and complications related to tracheotomy and because of the concerned vital function, the cannula replacement leads to anxiety especially during the first replacements. Usual patient's anxiety management consists in reassuring the patient during the replacement. In other situations, patients' anxiety management would be drugs, however due to sedative and anxiolytic drugs' adverse events and to the need to maintain optimal breathing, they are not used in first intention. Our choice is to use conversational hypnosis during cannula replacement as it has already demonstrated interesting effects in pain and anxiety. Conversational hypnosis does not present an induction phase like in so-called hypnosis, it aims at leading the patient to perceive his/her world differently with only a slight consciousness alteration.
Detailed Description:
Once the informed consent form is signed and when the cannula replacement has to be performed, conversational hypnosis session will start right from the patient's room entrance and end when the nurse will come out. The care will consist in aspiration, cleaning and finally replacement of the cannula. Adverse events are expected to be related to the cannula replacement itself: patients will be followed-up during a maximum of 7 days with one follow-up visit which will take place 2 hours after cannula replacement and a second one which can take place from the day after the replacement up to just before the following replacement.
Study:
NCT02977767
Study Brief:
Protocol Section:
NCT02977767