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OpenTrials
Completed

NCT Number: NCT00806832

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.

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Key information

Conditions

Blood Pressure Heart Rate

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Ha'Emek MC

Afula, 18101, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood pressure

    Time frame: day of surgery

Secondary outcomes

  1. heart rate

    Time frame: day of surgery

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Dec 11, 2008
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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