ArrythmiaNCT01988064
Face to Face vs. Group Training Methods on Pulse Rate Taking in Patients With Cardiovascular Diseases.
A study testing Face-to-face training and Group training in people with Arrythmia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to compare the efficacy of group training using a tutorial film and one-to-one face-to-face training in calculating the pulse rate and detecting irregularity in the pulse rhythm in patients with cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arrythmia
- What is being tested?
- Face-to-face training and Group training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIran
- Study dates
- Oct 2013to Jun 2014
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted in cardiology ward
- Literacy (ability to read and write)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Cardiovascular research center, Modarres hospital.
Tehran, Tehran Province
Morteza Safi, Head, +98 21 2208 3106, info@sbcvrc.org
+98 935 909 9440, Mortezasaafi@yahoo.com
About this study
Official title: 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.
The aim of this study is to compare the efficacy of group training using a tutorial film and one-to-one face-to-face training in calculating the pulse rate and detecting irregularity in the pulse rhythm in patients with cardiovascular diseases.
Read the 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.
- Conditions
- Arrythmia
- Being tested
- Face-to-face training, Group training
- Keywords
- pulse rate, patient education, training
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face trainingOther
One-to-one face-to-face training on calculating the pulse rate and detecting abnormalities.
Group trainingOther
Group training using a tutorial film on calculating the pulse rate and detecting abnormalities.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face training | Experimental | One-to-one face-to-face training on calculating the pulse rate and detecting pulse abnormalities performed by the nurse. Receives: Other: Face-to-face training |
| Group training | Experimental | Group training using a tutorial film on calculating the pulse rate and detecting pulse abnormalities. Receives: Other: Group training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to calculated the pulse rate correctly and detected pulse irregularity
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArrythmiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeed Alipour Parsa, Shahid Beheshti University of Medical Sciences
- Investigators
- Habibolah Saadat, Professor of cardiology, Principal investigator, Cardiovascular research center, Modarres hospital, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988064
- Sponsor's protocol ID
- sbcvrc-106-1014
- Status last verified
- Nov 2013
- First submitted
- 4 Nov 2013
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17903977Hwu 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.
PubMed 11022503Breckwoldt 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.
PubMed 19632755
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01988064
- Acronym / sponsor ID
- sbcvrc-106-1014
- Conditions
- Arrythmia
- Keywords
- pulse rate, patient education, training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 20 Nov 2013 (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.
The aim of this study is to compare the efficacy of group training using a tutorial film and one-to-one face-to-face training in calculating the pulse rate and detecting irregularity in the pulse rhythm in patients with cardiovascular diseases.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-face training | Experimental | Other: Face-to-face trainingOne-to-one face-to-face training on calculating the pulse rate and detecting pulse abnormalities performed by the nurse. |
| Group training | Experimental | Other: Group trainingGroup training using a tutorial film on calculating the pulse rate and detecting pulse abnormalities. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted in cardiology ward
- Literacy (ability to read and write)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-face trainingOne-to-one face-to-face training on calculating the pulse rate and detecting abnormalities. | Other | Face-to-face training |
| Group trainingGroup training using a tutorial film on calculating the pulse rate and detecting abnormalities. | Other | Group training |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Background: PubMed 17903977Munschauer 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.
- Background: PubMed 11022503Hwu 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.
- Background: PubMed 19632755Breckwoldt 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.
Related trials for Arrythmia
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Southeast Asian Brugada Syndrome Cohort
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
Habibolah Saadat, Professor of cardiology principal investigator
Cardiovascular research center, Modarres hospital, Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face training and Group training in people with Arrythmia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Nov 2013. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT01988064, which also lists 3 linked publications.
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 20 Nov 2013.