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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hypnosis for Eye Surgery

NCT00176098

Cataract

UNKNOWN PHASE1/PHASE2

The Relationship Between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients

NCT06861764

Cohort Studies

COMPLETED

Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.

NCT05036538

Preoperative Stress Postoperative Cognitive Dysfunction Postoperative Delirium

RECRUITING NA

The Experience of Loneliness Among Patients During the Perioperative Period

NCT01203761

Anxiety Depression

UNKNOWN

Relationship Between Perioperative Sleep Disturbance and Postoperative Delirium

NCT05457387

Postoperative Delirium

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure Heart Rate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Conventional treatment only

Patients scheduled for elective cataract surgery will receive only conventional pre-operative treatment

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No