Non-pharmacological Intervention for Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00913861
Recruitment Status : Terminated (affiliation's change of the principal investigator need a new review bord)
First Posted : June 4, 2009
Last Update Posted : June 3, 2014
Information provided by (Responsible Party):
Cheseaux Nicole, University Hospital, Geneva

May 22, 2009
June 4, 2009
June 3, 2014
May 2009
December 2014   (Final data collection date for primary outcome measure)
total dose of propofol [ Time Frame: the day of the colonoscopy, at the end ]
Same as current
Complete list of historical versions of study NCT00913861 on Archive Site
  • gastroenterologist's satisfaction and quality of the colonoscopy [ Time Frame: the day of the procedure, at the end of the procedure ]
  • vital parameters [ Time Frame: during all the procedure, every 5 minutes ]
  • patient's comfort [ Time Frame: during the procedure every 10 minutes and 1 and 14 days after the colonoscopy ]
  • anxiety state [ Time Frame: between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after the end of the procedure ]
  • patient's satisfaction [ Time Frame: between 5 minutes to 1 hour after the end of the procedure and 1 and 14 days after the colonoscopy ]
  • duration of the procedure [ Time Frame: the day of the procedure ]
Same as current
Not Provided
Not Provided
Non-pharmacological Intervention for Colonoscopy
Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Colonoscopy
  • Sedation
  • Hypnosis
  • Behavioral: 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.
    Other Name: hypnotic state
  • Drug: standard sedation
    Standard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0.
    Other Name: Disoprivan (propofol)and fentanyl
  • Behavioral: 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.
    Other Name: psychological support
  • Active Comparator: standard sedation
    propofol and fentanyl
    Intervention: Drug: standard sedation
  • Active Comparator: structured attention-standard sedation
    structured attention
    Intervention: Behavioral: Structured attention
  • Experimental: hypnosis-standard sedation
    Intervention: Behavioral: hypnosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
NAC 08-072
Not Provided
Not Provided
Cheseaux Nicole, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Nicole Cheseaux, MD Division of Anesthesiology, University Hospitals, Geneva
University Hospital, Geneva
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP