Protocol summary

Summary
This study is aiming to identify the prevalence of psychological distress among preclinical medical student then it will explore the possible causes of stress by identifying the main stressor factors. Then it will be followed by an intervention program to help the students cope with these stressors in order to decrease, if not eliminate, the psychological distress that they feel. This will make this study a comprehensive approach towards the problem of psychological distress among medical students. The selection of the preclinical students is determined in order to identify the problem at early stages in order to help the students to cope with their future stress in clinical years as the studies showed that the stress levels as persistent throughout the years of medical education as well as in physicians under-training

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050627756N1
Registration date: 2016-08-14, 1395/05/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-14, 1395/05/24
Registrant information
Name
Maher Fuad
Name of organization / entity
Universiti Putra Malaysia
Country
Malaysia
Phone
+60 3-8946 6000
Email address
gs33742@mutiara.upm.edu.my
Recruitment status
Recruitment complete
Funding source
The study is funded by initiative RUGS 3 of Universiti Putra malaysia
Expected recruitment start date
2014-01-18, 1392/10/28
Expected recruitment end date
2014-06-18, 1393/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
STRESS, ANXIETY AND DEPRESSION AMONG PRECLINICAL MEDICAL STUDENTS OF UNIVERSITI PUTRA MALAYSIA AND THE EFFECT OF MINDFULNESS ON DASS-21 SCORES
Public title
STRESS, ANXIETY AND DEPRESSION AMONG PRECLINICAL MEDICAL STUDENTS OF UNIVERSITI PUTRA MALAYSIA AND THE EFFECT OF MINDFULNESS ON DASS-21 SCORES
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Students with mild, moderate and high distress scores; Preclinical undergraduate medical students; Willing to participate Exclusion Criteria:Students who do not give their consent to participate in the study; Clinical undergraduate students; Extremely severe distress scores will be referred to psychiatrist evaluation.
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A baseline cross sectional study is conducted to determine the students with high stress, anxiety and depression scores

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics Committee of the Universiti Putra Malaysia (JKEUPM)
Street address
Pejabat Timbalan Naib Canselor (penyedidikan dan Inovasi) Universiti Putra Malaysia
City
Serdang
Postal code
43400
Approval date
2013-08-26, 1392/06/04
Ethics committee reference number
UPM/TNCPI/RMC/JKEUPM/1.4.18.1/F1

Health conditions studied

1

Description of health condition studied
Stress, Anxiety and Depression
ICD-10 code
Z56.3
ICD-10 code description
Stressful work schedule

Primary outcomes

1

Description
Stress and Anxiety
Timepoint
Baseline and after 8 weeks
Method of measurement
DASS-21 and GHQ-12

Secondary outcomes

1

Description
Depression
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
PHQ-9, SSKM-20

Intervention groups

1

Description
The intervention group will receive the One-Day Mindfulness program (ODM) which consist of two sessions (Morning and afternoon sessions) The morning session explains the ABC of stress, anxiety and depression (SAD). It explains the definition, and types. Then the basic mechanism and the benefit of mindfulness will be explained. Students will be trained in Mindful Stretching & Muscle Relaxation as well as a training to anchor attention by labeling their actions and to pay attention to hearing, touching and seeing (HTC Method) the surrounding environment to help them appreciate it. Students are trained also in deep and mindful breathing as well as mindful imagery. The afternoon session included teaching the student on how to apply mindfulness in their daily life in order to Transform their thoughts (especially the negative one) into happy one. The session will involve a movie, a song and the application of mindful STOP technique which enabled the students to access mindfulness anytime and anywhere.
Category
Treatment - Other

2

Description
The control group is the wait-listed group and they will receive the intervention at the end of the study.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Putra Malaysia, faculty of Medicine and Health Sciences
Full name of responsible person
Dr. Maher D. Fuad
Street address
Serdang
City
Serdang

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Putra Malaysia
Full name of responsible person
Associate Prof. Dr. Normala Ibrahim
Street address
Faculty of Medicine and Health Science, University of Putra Malaysia
City
Serdang
Grant name
Grant code / Reference number
RUGS initiative 3
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Putra Malaysia
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Dr. Maher D. Fuad Fuad
Position
PhD candidate
Other areas of specialty/work
Street address
K-10-3A Subang Olives Residence, Jalan kemajuan Subnag, SS16
City
Subang Jaya
Province
Selangor
Postal code
47500
Phone
0060350366626
Fax
Email
maherazawi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Dr. Maher D. Fuad Fuad
Position
PhD Candidate
Other areas of specialty/work
Street address
K-10-3A Subang Olives resoidence, jalan kemajuan Subang, SS16
City
Subang Jaya
Province
Selangor
Postal code
47500
Phone
0060350366626
Fax
Email
maherazawi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Universiti Putra malaysia
Full name of responsible person
Dr. maher D. Fuad Fuad
Position
PhD candidate
Other areas of specialty/work
Street address
K-10-3A Suabng Olives Residence, jalan kemajuan subang, Ss16
City
Subang jaya
Province
selangor
Postal code
47500
Phone
0060350366626
Fax
Email
maherazawi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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