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

July 6, 2015 updated by: HaEmek Medical Center, Israel

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Locations

Israel
- - Afula, Israel, 18101
    - Department of Ophthalmology, Ha'Emek MC

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will include patients from the town of Afula and its surrounding region who are scheduled for cataract surgery in Ha'Emek Medical Center.

Description

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 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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Medical clowns treatment Patients scheduled for an elective cataract surgery will receive pre-operative conventional treatment and in addition will be exposed to medical clowns effect
Conventional treatment only Patients scheduled for elective cataract surgery will receive only conventional pre-operative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood pressure Time Frame: day of surgery	day of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
heart rate Time Frame: day of surgery	day of surgery

Collaborators and Investigators

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

Sponsor

HaEmek Medical Center, Israel

Investigators

Principal Investigator: Yaron Lang, MD, Dept. of Ophthalmology, Ha'Emek MC, Afula, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.

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

December 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 9, 2008

First Submitted That Met QC Criteria