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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00806832
First received: December 9, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted

December 9, 2008
December 9, 2008
December 2008
April 2009   (final data collection date for primary outcome measure)
Blood pressure [ Time Frame: day of surgery ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
heart rate [ Time Frame: day of surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia
The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia

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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.
  • Blood Pressure
  • Heart Rate
Not Provided
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact: Yaron Lang, MD 972-54-4449060 ylang@012.net.il
Israel
 
NCT00806832
0087-08-EMC
No
Yaron Lang, MD, Department of Ophthalmology, HaEmek MC, Afula, Israel
HaEmek Medical Center, Israel
Not Provided
Principal Investigator: Yaron Lang, MD Dept. of Ophthalmology, Ha'Emek MC, Afula, Israel
HaEmek Medical Center, Israel
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP