Evaluation of the Effect of Conversational Hypnosis When Changing Tracheal Cannula in Adult Patients (HYPNO-TRACH)
January 4, 2024 updated by: Centre Hospitalier Universitaire de la Réunion
Evaluation of the Effect of Conversational Hypnosis When Changing Tracheal Cannula in Adult Patients: a Pilot Study
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.
Study Overview
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients hospitalised in the Ear, Nose, Throat - specialties surgery department
- aged of 18 years old and more
- having a tracheotomy following an upper aero-digestive tracts obstruction
- presenting a tracheal cannula which can be replaced by paramedical staff
- able to communicate to give their consent
- member or beneficiary of a social security assurance
- having given a signed informed consent form
Exclusion Criteria:
- patients presenting a hearing loss (preventing from hearing properly the words pronounced during conversational hypnosis)
- who do not understand French
- who are under curators/guardianship
- presenting dementia
- autonomous in their cannula replacement
- having already participated in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Conversational hypnosis
Use of conversational hypnosis during the tracheal cannula replacement
|
Conversational hypnosis starts since the enter of the nurse in patient's room and last since the nurse leaves the room.
Change of canula is performed under conversational hypnosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to change the tracheal cannula using conversational hypnosis
Time Frame: On the patient's scope, time measured from the moment the nurse says "now we start" according to the conversational hypnosis protocol to the time the new cannula is fixed around the patient's neck, assessed up to 1 hour (3600 seconds).
|
Once the written informed consent form is obtained, the tracheal cannula change to perform in the frame of the study can be performed.
As the patient will be scoped, the time to change the cannula will be monitored: the nurse will use an indicator on the scope to mark the start of the cannula change (when the sentence "now we start" is pronounced according to the conversational hypnosis protocol) and an indicator is placed on the scope when the new cannula is fixed around the patient's neck.
The time between the two indicators will be reported in the Case Report Form in seconds.
|
On the patient's scope, time measured from the moment the nurse says "now we start" according to the conversational hypnosis protocol to the time the new cannula is fixed around the patient's neck, assessed up to 1 hour (3600 seconds).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daw-Horng WU, MD, CHU La Réunion
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2018
Primary Completion (Estimated)
November 1, 2019
Study Completion (Estimated)
March 1, 2020
Study Registration Dates
First Submitted
November 23, 2016
First Submitted That Met QC Criteria
November 28, 2016
First Posted (Estimated)
November 30, 2016
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2016/CHU/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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