Non-pharmacological Intervention for Colonoscopy

NCT00913861 | Terminated

• 2 other identifiers: 08-238NAC 08-072
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy; Sedation; Hypnosis

Keywords

endoscopy; comfort; non-pharmacological

Outcome Measures

Primary Outcomes (1)

• total dose of propofol

  the day of the colonoscopy, at the end

Secondary Outcomes (6)

• 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

Study Arms (3)

standard sedation

ACTIVE COMPARATOR

propofol and fentanyl

Drug: standard sedation

structured attention-standard sedation

ACTIVE COMPARATOR

structured attention

Behavioral: Structured attention

hypnosis-standard sedation

EXPERIMENTAL

hypnosis

Behavioral: hypnosis

Interventions

hypnosis 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.

Also known as: hypnotic state

hypnosis-standard sedation

standard sedation DRUG

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

Also known as: Disoprivan (propofol)and fentanyl

standard sedation

Structured attention 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.

Also known as: psychological support

structured attention-standard sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients classified as ASA 1 to 3
• colonoscopy with anesthesiological support
• capacity of consenting

You may not qualify if:

• pregnancy
• colonoscopy with gastroscopy
• emergency
• psychotic diseases
• deafness
• incapacity to understand french
• addiction of drugs and alcohol
• psychoactive drugs

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Division of Anesthesiology, University Hospitals of Geneva

Geneva, Canton of Geneva, CH-1211, Switzerland

Location

MeSH Terms

Interventions

Hypnosis; Propofol

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nicole Cheseaux, MD

  Division of Anesthesiology, University Hospitals, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: June 4, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 3, 2014

Record last verified: 2014-06

Locations

CH (1)