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

NCT00806832 | Completed

• 1 other identifier: 0087-08-EMC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Heart Rate

Keywords

Medical clowns; Cataract surgery; Blood pressure; Heart rate

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  day of surgery

Secondary Outcomes (1)

• heart rate

  day of surgery

Study Arms (2)

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 Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Department of Ophthalmology, Ha'Emek MC

Afula, 18101, Israel

Location

Related 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. doi: 10.1542/peds.2005-0466.

  PMID: 16199685 BACKGROUND

Study Officials

• Yaron Lang, MD

  Dept. of Ophthalmology, Ha'Emek MC, Afula, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 11, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: March 1, 2010
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

IL (1)