Hypnosis for Eye Surgery

Phase 1

• Conditions: Cataract

• Registration Number: NCT00176098
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-09
• Study Start: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Last Update Submitted: 2006-02-06
• Last Update Posted: 2006-02-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Cataract

Exclusion Criteria

• Uncorrected hearing disability
• Pharmacological beta-blockade

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of perioperative stress
Improvement of patient comfort and safety

Secondary Outcome Measures

Name	Time	Method
Correlation of hypnotic depth with bispectral index (BIS)

Trial Locations

Locations (1)

Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg; 🇩🇪 Mannheim, Germany