Colonoscopy, Hypnosis, Sedation
Conditions
Keywords
endoscopy, comfort, non-pharmacological
Brief summary
The purpose of this study is to determine whether a non-pharmacological intervention reduces consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce side effects. This non-pharmacological intervention may increase patient's comfort and security.
Detailed description
Sedative and analgesic drugs are used in most patients related to pain and anxiety during the colonoscopy. Analgesia and sedation has adverse effects such as central respiratory depression, obstruction of the upper airways, hypoxia, hypotension and bradycardia. Non-pharmacological interventions had beneficial effects during percutaneous vascular or renal procedures. In this study we test the hypothesis that the adjunction of hypnosis to pharmacological sedation will decrease the quantity of sedative drugs used and will reduce the patient's anxiety and discomfort.
Interventions
BEHAVIORALhypnosis
Hypnosis: induction of hypnosis by visual fixation and recollection of a pleasant memory, suggestion of relaxation, of self-control and post-hypnotic suggestion for bowel relaxation.
Standard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0.
BEHAVIORALStructured attention
Structured attention: verbal and nonverbal communication; attentive listening; provision of the perception of control; encouragement; use of emotionally neutral descriptors, focus on a sensations.
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients classified as ASA 1 to 3 * colonoscopy with anesthesiological support * capacity of consenting
Exclusion criteria
* pregnancy * colonoscopy with gastroscopy * emergency * psychotic diseases * deafness * incapacity to understand french * addiction of drugs and alcohol * psychoactive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total dose of propofol | the day of the colonoscopy, at the end |
Secondary
| Measure | Time frame |
|---|---|
| vital parameters | during all the procedure, every 5 minutes |
| patient's comfort | during the procedure every 10 minutes and 1 and 14 days after the colonoscopy |
| gastroenterologist's satisfaction and quality of the colonoscopy | the day of the procedure, at the end of the procedure |
| patient's satisfaction | between 5 minutes to 1 hour after the end of the procedure and 1 and 14 days after the colonoscopy |
| duration of the procedure | the day of the procedure |
| anxiety state | between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after the end of the procedure |
Countries
Switzerland
Outcome results
None listed