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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806832
First Posted: December 11, 2008
Last Update Posted: July 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
HaEmek Medical Center, Israel
  Purpose
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.

Condition
Blood Pressure Heart Rate

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: day of surgery ]

Secondary Outcome Measures:
  • heart rate [ Time Frame: day of surgery ]

Estimated Enrollment: 100
Study Start Date: December 2008
Study Completion Date: March 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806832


Locations
Israel
Department of Ophthalmology, Ha'Emek MC
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Yaron Lang, MD Dept. of Ophthalmology, Ha'Emek MC, Afula, Israel
  More Information

Publications:
Responsible Party: Yaron Lang, MD, Department of Ophthalmology, HaEmek MC, Afula, Israel
ClinicalTrials.gov Identifier: NCT00806832     History of Changes
Other Study ID Numbers: 0087-08-EMC
First Submitted: December 9, 2008
First Posted: December 11, 2008
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by HaEmek Medical Center, Israel:
Medical clowns
Cataract surgery
Blood pressure
Heart rate

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases