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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806832
• Other study ID #: 0087-08-EMC
• Status: Completed
• Phase: N/A
• First received: December 9, 2008
• Last updated: July 6, 2015
• Start date: December 2008
• Est. completion date: March 2010

Study information

• Verified date: July 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Pressure
• Cataract
• Heart Rate

Locations

Country	Name	City	State
Israel	Department of Ophthalmology, Ha'Emek MC	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		day of surgery	Yes
Secondary	heart rate		day of surgery	Yes