Non-pharmacological Intervention for Colonoscopy

Not Applicable

Terminated

• Conditions: Colonoscopy; Sedation; Hypnosis
• Interventions: Drug: standard sedation; Behavioral: Structured attention; Behavioral: hypnosis

• Registration Number: NCT00913861
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-03
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard sedation	standard sedation	propofol and fentanyl
structured attention-standard sedation	Structured attention	structured attention
hypnosis-standard sedation	hypnosis	hypnosis

Primary Outcome Measures

Name	Time	Method
total dose of propofol	the day of the colonoscopy, at the end

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Anesthesiology, University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland