Hypnosis for Eye Surgery

February 6, 2006 updated by: Heidelberg University

Correlation of Stress, Patient Comfort and Safety to Bispectral Index in Patients Under Hypnosis for Cataract Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Mannheim, Germany, 68167
        • Recruiting
        • Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg
        • Contact:
        • Sub-Investigator:
          • Michael Schoeler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 95 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cataract

Exclusion Criteria:

  • Uncorrected hearing disability
  • Pharmacological beta-blockade

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of perioperative stress
Improvement of patient comfort and safety

Secondary Outcome Measures

Outcome Measure
Correlation of hypnotic depth with bispectral index (BIS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Study Chair: Thomas Frietsch, MD, PhD, Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2006

Last Update Submitted That Met QC Criteria

February 6, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TF-KliMa-2005-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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