- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01988064
Face to Face vs. Group Training Methods on Pulse Rate Taking in Patients With Cardiovascular Diseases.
Comparison of the Short-term Efficacy of Two Training Methods (Face to Face vs. Group Training) on Pulse Rate Taking in Patients With Cardiovascular Diseases, a Randomized Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pulse rate self-examination can provide a fairly good assessment of the patient's condition and helps the physician with drug dosage adjustment in patients with cardiac problems.
This study will be conducted in the Cardiology wards of Modarres and Loghman hospitals in Tehran. These are two educational general referral hospitals of Shahid Beheshti University of medical sciences covering northern and southern part of Tehran, the capital of Iran respectively.
After obtaining a written consent the patients will randomly assign into two groups using random number table. One group will receive a 20-minute face-to-face training session by a nurse on how to calculate the pulse rate in a minute and detect irregularities in the pulse rhythm whereas a 10-minute tutorial film with the same content will be shown to the other group.
Three practical test sessions are arranged for each patient, before the training session, right after the training session and at least 48 hours after the training session. The tests contain two parts and evaluate the patients' ability in calculating the exact pulse rate in a minute and detecting irregularities in the pulse rhythm.
A special data-collecting questionnaire is designed for this study. This questionnaire contains background information such as sex, age, and literacy level as well as the practical test results. Data gathering process will be performed by nurses in these hospitals. Nurses, who participate in this study, will attend in briefing sessions on how to fill the data-collecting questionnaires.
The sample size consists of 300 patients who admitted in Cardiology ward (200 in Modarres hospital and 100 in Loghman hospital). The data will be inserted to the computer and the variables will be compared within and between groups using SPSS software version 16.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tehran, Iran, Islamic Republic of
- Recruiting
- Cardiovascular research center, Modarres hospital.
-
Contact:
- Morteza Safi, Head
- Phone Number: +98 21 2208 3106
- Email: info@sbcvrc.org
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Contact:
- Phone Number: +98 935 909 9440
- Email: Mortezasaafi@yahoo.com
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Principal Investigator:
- Habibolah Saadat, Professor of cardiology
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Principal Investigator:
- Roxana Sadeghi, Fellowship of cardiology
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Sub-Investigator:
- Maryam Jannatipour, Resident of cardiology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients admitted in cardiology ward
- Literacy (ability to read and write)
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Face-to-face training
One-to-one face-to-face training on calculating the pulse rate and detecting pulse abnormalities performed by the nurse.
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One-to-one face-to-face training on calculating the pulse rate and detecting abnormalities.
|
Experimental: Group training
Group training using a tutorial film on calculating the pulse rate and detecting pulse abnormalities.
|
Group training using a tutorial film on calculating the pulse rate and detecting abnormalities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ability to calculated the pulse rate correctly and detected pulse irregularity
Time Frame: The outcome will be measured on three distinct time points; before the training session(base line), right after the training session, and at least 48 hours after the training session
|
The number of participants who can calculate the pulse rate correctly and detect pulse irregularity, and the participants' improvement in the ability to calculated the pulse rate correctly and detected pulse irregularity on the three time points, will be compared between the two groups.
|
The outcome will be measured on three distinct time points; before the training session(base line), right after the training session, and at least 48 hours after the training session
|
Collaborators and Investigators
Investigators
- Principal Investigator: Habibolah Saadat, Professor of cardiology, Cardiovascular research center, Modarres hospital, Shahid Beheshti University of Medical Sciences
Publications and helpful links
General Publications
- Munschauer FE 3rd, Sohocki D, Smith Carrow S, Priore RL. A community education program on atrial fibrillation: implications of pulse self-examination on awareness and behavior. J Stroke Cerebrovasc Dis. 2004 Sep-Oct;13(5):208-13. doi: 10.1016/j.jstrokecerebrovasdis.2004.08.001.
- Hwu YJ, Coates VE, Lin FY. A study of the effectiveness of different measuring times and counting methods of human radial pulse rates. J Clin Nurs. 2000 Jan;9(1):146-52. doi: 10.1046/j.1365-2702.2000.00350.x.
- Breckwoldt J, Schloesser S, Arntz HR. Perceptions of collapse and assessment of cardiac arrest by bystanders of out-of-hospital cardiac arrest (OOHCA). Resuscitation. 2009 Oct;80(10):1108-13. doi: 10.1016/j.resuscitation.2009.06.028. Epub 2009 Jul 25.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- sbcvrc-106-1014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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