Back to resultsHypnosis for Eye Surgery
Primary Purpose
Cataract
Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Hypnoanalgesia; Hypnotic shielding
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract surgery, Hypnosis, C11.510.245, F04.754.424.771, Suggestion
Eligibility Criteria
Inclusion Criteria: Cataract Exclusion Criteria: Uncorrected hearing disability Pharmacological beta-blockade
Sites / Locations
- Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of HeidelbergRecruiting
Outcomes
Primary Outcome Measures
Reduction of perioperative stress
Improvement of patient comfort and safety
Secondary Outcome Measures
Correlation of hypnotic depth with bispectral index (BIS)
Full Information
NCT ID
NCT00176098
First Posted
September 12, 2005
Last Updated
February 6, 2006
Sponsor
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT00176098
Brief Title
Hypnosis for Eye Surgery
Official Title
Correlation of Stress, Patient Comfort and Safety to Bispectral Index in Patients Under Hypnosis for Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
4. Oversight
5. Study Description
Brief Summary
Perioperative stress for cataract surgery in the elderly is considerable even in the absence of pain. For these patients with a high comorbidity level, the perioperative situation comprising factors such as uncomfortable positioning, dull ambience, face cover, poor sedation, and anxiety might not only reduce intraoperative compliance but induce cardiac ischemia and hypertensive crises. Hypnosis is supposed to increase patient comfort, to shield the patient from organic stress and to improve intraoperative compliance without side effects even in old and very ill patients. In a controlled study, we, the investigators at the University of Heidelberg, compared phakoemulsification under topical anesthesia as usual (and placebo hypnosis) with either additional hypnosis or hypnoanalgesia without topical anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract surgery, Hypnosis, C11.510.245, F04.754.424.771, Suggestion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hypnoanalgesia; Hypnotic shielding
Primary Outcome Measure Information:
Title
Reduction of perioperative stress
Title
Improvement of patient comfort and safety
Secondary Outcome Measure Information:
Title
Correlation of hypnotic depth with bispectral index (BIS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cataract
Exclusion Criteria:
Uncorrected hearing disability
Pharmacological beta-blockade
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Frietsch, MD, PhD
Phone
+49 621 383 2903
Email
thomas.frietsch@urz.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Schoeler, MD
Phone
+49 621 383 2415
Email
michael.schoeler@anaes.ma.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Frietsch, MD, PhD
Organizational Affiliation
Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Frietsch, MD, PhD
Phone
+49 621 383 2903
Email
thomas.frietsch@urz.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Michael Schoeler, MD
12. IPD Sharing Statement
Learn more about this trial
Hypnosis for Eye Surgery
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