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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04243291
Other study ID # 40609
Secondary ID 04-01-18-1972FR
Status Completed
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date March 30, 2022

Study information

Verified date May 2022
Source Universiti Putra Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study mainly to investigate the prevalence of road crash involvement and its associated factors (fatigue, demographic factors, sleep quality, and mental health status, number of working hours) among medical doctors in Malaysia.


Description:

The incidence reports of road crash involvement among medical doctors in Malaysia have steadily increased in frequency by 28%. Despite the gravity of the situation, there is an obvious absence of further information regarding the causes of such occurrence. A deeper look into literature regarding the phenomenon worldwide indicates that the prevalence of road crash involvement among doctors are less reported on, much less the factors associated with it. hence, investigators constructed a research to investigate the prevalence of road crash involvement and its associated factors (fatigue, demographic factors, sleep quality, and mental health status, number of working hours) among medical doctors in Malaysia. It is a cross sectional study where the study population consists of Malaysian Medical Association (MMA) members who are fully or partially registered with the Malaysian Medical Council (MMC) and their contacts. Respondents will be selected via non probability random sampling among MMA registered member list and their network. The sample will be doctors who are partially or fully registered with the Malaysian Medical Council and following the inclusion and exclusion criteria. The participants who are eligible will need to answer via an online survey link. Inclusion criteria - Malaysian citizen - Full or partial registration with MMC - Work a minimum of six (6) months in public healthcare sector in Malaysia. Doctors who have just been working for less than six months are still adapting to the duties and atmosphere of the hospital, and the responsibilities they hold are also different from those of a senior doctor making them not suitable to include in this study. Exclusion criteria - Medical doctors currently on a long leave. As investigators only have a short period of data collection, so investigators will exclude this group of subject. - Does not self-commute to work CALCULATED SAMPLE SIZE = 288. This study will be in collaboration with Malaysian Medical Associations (MMA) on recruiting sample for this research along with other medical NGOs. MMA will help in dissemination of information throughout their website as well as distribute/email the questionnaires to all MMA members and their contacts. The questionnaire will be created by using Google Form and then saved on Google Drive. Then MMA will share the form to all their members through email. All responses will be saved in the file stored in Google Drive. Once enough sample acquired, the form will be closed and results will be download for data analysis. Data entry and analysis will be undertaken by using the 'Statistical Package for Social Sciences' (SPSS) programme, Version 22.0. The statistical significance level is taken at the p value <0.05 with 95% of confidence intervals (CI). The continuous variables will be summarised by using means and standard deviation (SD) and predominantly categorised as required and presented as the number (n) and percentage (%). The statistics analysis will utilise the Pearson Chi-square test for obtaining the statistical difference of the categorical variables. Lastly, logistic regression analysis will be used to describe the strength of association between the outcome and factors of interest, adjusting for covariates or confounders. It also allows one to determine the important factors affecting the outcome and generate the final model for the factors being studied as the predictor for the outcomes. Study Instrument: Questionnaire/scoring & Pilot study This study's approval for ethical clearance will be obtained from Medical Research Ethics Committee (MREC), "University Putra Malaysia" (UPM). Informed consent will be obtained from each study participant and it will be stated at the beginning of the questionnaire.


Recruitment information / eligibility

Status Completed
Enrollment 375
Est. completion date March 30, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Malaysian citizen - Full or partial registration with MMC - Work a minimum of six (6) months in public healthcare sector in Malaysia. Doctors who have just been working for less than six months are still adapting to the duties and atmosphere of the hospital, and the responsibilities they hold are also different from those of a senior doctor making them not suitable to include in this study. Exclusion Criteria: - Medical doctors currently on a long leave. As we only have a short period of data collection, so we will exclude this group of subject. - Does not self-commute to work

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Malaysia Universiti Putra Malaysia Seri Kembangan Selangor

Sponsors (1)

Lead Sponsor Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (10)

Aneesa AR, Suhazeli A, Nur Asyikin M, Munawar S, Nur Asyraf M , Siti Illiana M, et al. Post Call MVA Survey: An 18 Hour Online Survey. In: 17th Islamic Association of Malaysia (IMAM) Annual Scientific Conference (ASC). Penang, Malaysia; 2015.

Azhar A. Commuting Accidents : What Does Research Shows ? COMMUTING ACCIDENTS PREVENTION SEMINAR MONASH UNIVERSITY MALAYSIA 9 - 10 DECEMBER 2014. 2014.

Barger LK, Cade BE, Ayas NT, Cronin JW, Rosner B, Speizer FE, Czeisler CA; Harvard Work Hours, Health, and Safety Group. Extended work shifts and the risk of motor vehicle crashes among interns. N Engl J Med. 2005 Jan 13;352(2):125-34. — View Citation

Fruchtman Y, Moser AM, Perry ZH. Fatigue in medical residents--lessons to be learned. Med Lav. 2011 Sep-Oct;102(5):455-63. — View Citation

Marcus CL, Loughlin GM. Effect of sleep deprivation on driving safety in housestaff. Sleep. 1996 Dec;19(10):763-6. — View Citation

Owens JA. Sleep loss and fatigue in healthcare professionals. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):92-100; quiz 101-2. Review. — View Citation

Pertubuhan Keselamatan Sosial. Laporan Tahunan Perkeso. 2015.

Steele MT, Ma OJ, Watson WA, Thomas HA Jr, Muelleman RL. The occupational risk of motor vehicle collisions for emergency medicine residents. Acad Emerg Med. 1999 Oct;6(10):1050-3. — View Citation

Veasey S, Rosen R, Barzansky B, Rosen I, Owens J. Sleep loss and fatigue in residency training: a reappraisal. JAMA. 2002 Sep 4;288(9):1116-24. Review. — View Citation

World Health Organization Western Pacific Region. Human Resource s for health country profiles : Malaysia. 2014.

Outcome

Type Measure Description Time frame Safety issue
Primary The Prevalence of Road Crash Involvement among Medical Doctors Self reported in sociodemographic questionnaire Since joining medical profession ( anywhere from one year up to 20 years )
Primary fatigue among Medical Doctors Checklist Individual Strength Questionnaire (CISQ) Since joining medical profession ( anywhere from one year up to 20 years )
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