Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 6:01 AM
Study NCT ID:
NCT00806832
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
2008-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-06', 'studyFirstSubmitDate': '2008-12-09', 'studyFirstSubmitQcDate': '2008-12-09', 'lastUpdatePostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'day of surgery'}], 'secondaryOutcomes': [{'measure': 'heart rate', 'timeFrame': 'day of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medical clowns', 'Cataract surgery', 'Blood pressure', 'Heart rate'], 'conditions': ['Blood Pressure', 'Heart Rate']}, 'referencesModule': {'references': [{'pmid': '16199685', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing an elective, ambulatory cataract surgery (phacoemulsification technique)\n* Surgery planned to be performed under local anesthesia\n* Age \\> 40 years\n* Patients signed an informed consent\n\nExclusion Criteria:\n\n* Hypertensive patients who did not take their prescribed medications on the day of surgery\n* Uncontrolled hypertension during the month preceding the surgery\n* Patients with systolic and diastolic BP values of \\>190 and 100 mmHg respectively, measured 1hr prior to surgery\n* Patients not suitable for surgery under local anesthesia\n* Patients in whom the planned phacoemulsification technique was converted to either the ECCE or ICCE technique\n* Patients in whom an anterior vitrectomy had to be performed during surgery\n* Patients treated regularly by anti-anxiety or analgetic treatment'}, 'identificationModule': {'nctId': 'NCT00806832', 'briefTitle': 'The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia', 'orgStudyIdInfo': {'id': '0087-08-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medical clowns treatment', 'description': 'Patients scheduled for an elective cataract surgery will receive pre-operative conventional treatment and in addition will be exposed to medical clowns effect'}, {'label': 'Conventional treatment only', 'description': 'Patients scheduled for elective cataract surgery will receive only conventional pre-operative treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': "Department of Ophthalmology, Ha'Emek MC", 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Yaron Lang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dept. of Ophthalmology, Ha'Emek MC, Afula, Israel"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yaron Lang, MD', 'oldOrganization': 'Department of Ophthalmology, HaEmek MC, Afula, Israel'}}}}