The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia

Completed

• Conditions: Blood Pressure; Heart Rate

• Registration Number: NCT00806832
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Cataract surgery is the most prevalent surgical procedure. Since most candidates are elderly patients, hypertension is common among these patients. Preoperative anxiety and tension may cause elevation of patient's heart rate and blood pressure and thus expose them to serious potential complications such as stroke and myocardial infarction. Medical clowns are known to reduce preoperative anxiety of both children and their parents. It is possible therefore that medical clown may have such a beneficial effect also on patients scheduled for cataract surgery under local anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-11
• Primary Completion: 2009-04
• Study Completion: 2010-03
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-06
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing an elective, ambulatory cataract surgery (phacoemulsification technique)
• Surgery planned to be performed under local anesthesia
• Age > 40 years
• Patients signed an informed consent

Exclusion Criteria

• Hypertensive patients who did not take their prescribed medications on the day of surgery
• Uncontrolled hypertension during the month preceding the surgery
• Patients with systolic and diastolic BP values of >190 and 100 mmHg respectively, measured 1hr prior to surgery
• Patients not suitable for surgery under local anesthesia
• Patients in whom the planned phacoemulsification technique was converted to either the ECCE or ICCE technique
• Patients in whom an anterior vitrectomy had to be performed during surgery
• Patients treated regularly by anti-anxiety or analgetic treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure	day of surgery

Secondary Outcome Measures

Name	Time	Method
heart rate	day of surgery

Trial Locations

Locations (1)

Department of Ophthalmology, Ha'Emek MC; 🇮🇱 Afula, Israel