Non-pharmacological Intervention for Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-12-31

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.

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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.

Conditions

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Colonoscopy Sedation Hypnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard sedation

propofol and fentanyl

Group Type ACTIVE_COMPARATOR

standard sedation

Intervention Type DRUG

Standard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0.

structured attention-standard sedation

structured attention

Group Type ACTIVE_COMPARATOR

Structured attention

Intervention Type BEHAVIORAL

Structured attention: verbal and nonverbal communication; attentive listening; provision of the perception of control; encouragement; use of emotionally neutral descriptors, focus on a sensations.

hypnosis-standard sedation

hypnosis

Group Type EXPERIMENTAL

hypnosis

Intervention Type BEHAVIORAL

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.

Interventions

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hypnosis

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.

Intervention Type BEHAVIORAL

standard sedation

Standard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0.

Intervention Type DRUG

Structured 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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hypnotic state Disoprivan (propofol)and fentanyl psychological support

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No