Blood PressureNCT00806832
The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia
An observational study of Blood Pressure and Heart Rate, run by HaEmek Medical Center, Israel at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Blood Pressure, Heart Rate
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: day of surgery
Secondary outcomes (1)
heart rate
Measured: day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Yaron Lang, MD, Principal investigator, Dept. of Ophthalmology, Ha'Emek MC, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806832
- Sponsor's protocol ID
- 0087-08-EMC
- Status last verified
- Jul 2015
- First submitted
- 9 Dec 2008
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16199685
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT00806832
- Acronym / sponsor ID
- 0087-08-EMC
- Conditions
- Blood Pressure, Heart Rate
- Keywords
- Medical clowns, Cataract surgery, Blood pressure, Heart rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure
Time frame: day of surgery
1 secondary outcome
heart rate
Time frame: day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
- Background: PubMed 16199685Vagnoli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Lang, MD principal investigator
Dept. of Ophthalmology, Ha'Emek MC, Afula, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Heart Rate, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00806832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.