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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01988064
Other study ID # sbcvrc-106-1014
Secondary ID
Status Recruiting
Phase N/A
First received November 4, 2013
Last updated November 13, 2013
Start date October 2013
Est. completion date June 2014

Study information

Verified date November 2013
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients admitted in cardiology ward

- Literacy (ability to read and write)

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Face-to-face training
One-to-one face-to-face training on calculating the pulse rate and detecting abnormalities.
Group training
Group training using a tutorial film on calculating the pulse rate and detecting abnormalities.

Locations

Country Name City State
Iran, Islamic Republic of Cardiovascular research center, Modarres hospital. Tehran

Sponsors (1)

Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 No
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