Non-pharmacological Intervention for Colonoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?

Conditions
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Colonoscopy, Sedation, Hypnosis

Intervention / Treatment
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* Behavioral: hypnosis
* Drug: standard sedation
* Behavioral: Structured attention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard sedation<br>propofol and fentanyl | Drug: standard sedation<br>* Standard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0.<br>* Other names: Disoprivan (propofol)and fentanyl;|
| Active Comparator: structured attention-standard sedation<br>structured attention | Behavioral: Structured attention<br>* Structured attention: verbal and nonverbal communication; attentive listening; provision of the perception of control; encouragement; use of emotionally neutral descriptors, focus on a sensations.<br>* Other names: psychological support;|
| Experimental: hypnosis-standard sedation<br>hypnosis | Behavioral: hypnosis<br>* 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.<br>* Other names: hypnotic state;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total dose of propofol |  | the day of the colonoscopy, at the end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastroenterologist's satisfaction and quality of the colonoscopy |  | the day of the procedure, at the end of the procedure | 
| 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 | 
| anxiety state |  | between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopy, comfort, non-pharmacological