Evaluation of factors related to depression and mental health and determining the effect of sleep and wake training workshop on these factors and immunological factors in students of Shiraz University of Medical Sciences in 96
1) Determining the demographic characteristics of volunteer students of Shiraz University of Medical Sciences in the study group 2) Determining and comparing the mean scores of psychological profile (using Beck Anxiety and Depression Questionnaire, Petersburg Sleep Quality Questionnaire) Volunteer students of Shiraz University of Medical Sciences before and after the workshop At the end of the sixth month in the study group 3) Determining and comparing the immunological profile with the following tests in volunteer students of Shiraz University of Medical Sciences before and after the workshop and at the end of the sixth month in the study group Human IL-1β Human IL-8 Human IFN-γ
Design
A controlled clinical trial with parallel, double-blind, randomized groups on 48 students was used for computerized randomization.
Settings and conduct
In this study, samples were collected and workshops were held in the medical school.
Participants/Inclusion and exclusion criteria
Student satisfaction, study at Shiraz University of Medical Sciences, absence of specific diseases including infectious diseases, diabetes, heart disease, psychological problems and such cases (with the diagnosis of the relevant doctor)
Intervention groups
Depression and anxiety questionnaires were filled out for the subjects before and after the intervention, and these individuals participated in two workshops.For the control group, the questionnaires were filled only at the same time and no training workshop was held.
Main outcome variables
Changing the level of safety factors after training workshops
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140622018187N10
Registration date:2020-08-08, 1399/05/18
Registration timing:retrospective
Last update:2020-08-08, 1399/05/18
Update count:0
Registration date
2020-08-08, 1399/05/18
Registrant information
Name
Sedighe Forouhari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 987136474257
Email address
foruharis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-05-21, 1397/02/31
Trial completion date
2018-08-22, 1397/05/31
Scientific title
Evaluation of factors related to depression and mental health and determining the effect of sleep and wake training workshop on these factors and immunological factors in students of Shiraz University of Medical Sciences in 96
Public title
Evaluation of factors related to depression and mental health and determining the effect of sleep and wake training workshop on these factors and immunological factors in students of Shiraz University of Medical Sciences in 96
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Student satisfaction, study at Shiraz University of Medical Sciences, absence of specific diseases including infectious diseases, diabetes, heart disease, psychological problems and such cases (with the diagnosis of the relevant doctor)
Exclusion criteria:
Dissatisfaction with research cooperation at any time during the research process, occurrence of any unexpected physical and psychological events
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Students will be divided into two equal groups based on simple random assignment based on simple research assignment, so that there will be about 24 people in each workshop group to provide better group and workshop training. It should be noted that randomization will be done based on a table of random numbers using a computer.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study and the patient and the researcher are unaware of how the groups are assigned.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Fatemeh School of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Approval date
2018-08-07, 1397/05/16
Ethics committee reference number
96-01-106-14782
Health conditions studied
1
Description of health condition studied
depression and anxiety
ICD-10 code
f32
ICD-10 code description
F30-39
Primary outcomes
1
Description
Depression
Timepoint
Before and after the workshop and 3 and 6 months after the workshop
Method of measurement
Beck Anxiety and Depression Inventories
2
Description
Anxiety
Timepoint
Before and after the workshop and 3 and 6 months after the workshop
Method of measurement
Beck Anxiety and Depression Inventories
3
Description
Blood safety factors
Timepoint
Before and 6 months after the workshop
Method of measurement
Immunological tests
4
Description
Sleep Quality
Timepoint
Before and after the workshop and 3 and 6 months after the workshop
Method of measurement
Petersburg Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Medical School
Full name of responsible person
Sedighe Forouhari
Street address
Shiraz
City
Fars
Province
Fars
Postal code
۷۱۵۳۸۱۳۳۱۱
Phone
+98 71 3726 6811
Email
foruharis@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Unes Ghasemi
Street address
Technology and Research Office, Research Deputy , Shiraz University of Medical Science, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
president@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Ph.D , Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1647 4257
Email
forouharism@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Foruhari
Position
Ph.D , Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1647 4257
Email
forouharism@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Ph.D , Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1647 4257
Email
forouharism@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available