Protocol summary

Study aim
The determin effect of natural circadian sunlight shifts on plasma melatonin and the depression and anxiety levels in submarine personnel’s.
Design
The study population consisted of two groups: control group: 26 each. No criteria for having a physical or mental illness; Awareness of the company; No use of drugs effective on the level of melatonin; lack of psychiatric disorders; lack of alcohol and other substance abuse; aged 21 to 30 years; randomly divided into two experimental and Control groups.
Settings and conduct
The experimental group uses artificial light from a natural cycle, such as sunlight, between 6am and 6pm for 5 days a week. From 6am, they automatically turn on and vary in intensity from the sun, while the control group will continue to experience their constant artificial light during the same period. The location of the research was a sub-surface work environment.
Participants/Inclusion and exclusion criteria
Participants are Iran's submarine personnel. They are healthy in terms of mental and physical health, gender-matched and healthy people between the ages of 21 to 30 years.
Intervention groups
The experimental group received natural light cycles such as sunlight between 6:00 AM and 6:00 PM for 5 days a week. For this purpose, four automatic light-emitting diodes were installed in the workshops, containing 400 light-hearted light-emitting diodes, such as sunlight, with intensity of radiation. From 6:00 AM it automatically became clear that the approximate time of sunrise and sunset was increased and the intensity of the sun was increased, and then the intensity of radiation shrank at a rate of about 68 lux per hour, and as a result, the light at 6 o'clock It was gone from noon.
Main outcome variables
Plasma levels of melatonin, depression scores and anxiety scores decreased significantly in the experimental group compared to the control group.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161112030846N2
Registration date: 2018-06-03, 1397/03/13
Registration timing: retrospective

Last update: 2018-06-03, 1397/03/13
Update count: 0
Registration date
2018-06-03, 1397/03/13
Registrant information
Name
Khodabakhsh Ahmadi
Name of organization / entity
Behavioral Sciences Research Center, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26127289
Email address
kh_ahmady@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
This study was funded by a grant from Baqiyatallah University of Medical Sciences.
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
2016-01-21, 1394/11/01
Actual recruitment end date
2017-01-20, 1395/11/01
Trial completion date
empty
Scientific title
Effect of Radiance-Dimmer Devices Simulating Natural Sunlight Rhythm on the Plasma Melatonin Levels and Anxiety and Depression Scores of the Submarine Personnel
Public title
Determining the effect of dim regulation by devices radiating according to natural circadian sunlight shifts
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Underground employees who use artificial light only during the period of their presence No specific disease or chronic physical and mental illness Male Have at least 21 and a maximum of 30 years
Exclusion criteria:
Taking medications that could affect serum melatonin levels including Having depression or any other major psychiatric disorders on DSM IV Having significant acute or chronic systemic disorders including type I diabetes mellitus, uncontrolled thyroid disorders, kidney/prostate/bladder problems which cause excessive urination, congestive heart failure, angina pectoris or other major cardiovascular disorders, hepatitis, asthma or severe respiratory allergies, stroke, Parkinson’s disease, Alzheimer’s disease, schizophrenia, epilepsy, oncologic disorders if less than 1 year since end of treatment, or chronic infections Use of hypnotics, melatonin, stimulants, or other medications that may affect melatonin levels (e.g. β blockers, drugs that affect prostaglandin synthesis, or drugs that activate hepatic melatonin metabolism) and unwillingness or inability to discontinue the occasional use of these medications for at least 4 weeks before beginning of the study
Age
From 21 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
Actual sample size reached: 52
Randomization (investigator's opinion)
Randomized
Randomization description
The members of the two bunch of staff were randomly divided into two experimental and control groups. Participants in the two groups did not differ significantly in terms of demographic characteristics such as gender, age, and educational level. In each group, 26 patients were tested and controlled.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
SheikhBahaie St. Mollasadra Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2017-02-15, 1395/11/27
Ethics committee reference number
IR.BMSU.REC.1395.232

Health conditions studied

1

Description of health condition studied
Anxiety and Depressive
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Anxiety
Timepoint
3 TIMES: Initiation, Middle and End of the study period
Method of measurement
Cattell’s Anxiety Scale Questionnaire (IPAT)

2

Description
Depression
Timepoint
3 TIMES: Initiation, Middle and End of the study period
Method of measurement
Minnesota Multiple Personality Inventory (MMPI)

3

Description
plasma melatonin hormone
Timepoint
3 TIMES: Initiation, Middle and End of the study period
Method of measurement
Blood examination

Secondary outcomes

empty

Intervention groups

1

Description
experimental group, In order to lighting the environment, 4 automatic optic devices were installed at the halls where personnel from the case group were working in, containing lamps expelling sunlight and moonlit with radiant intensity were 400 lox. These optic devices were automatic and turned on since 6 am automatically , which were approximate time of sunrise, and in a modal that conformities with increment of natural radiance of sunlight, 68 lox added to their radiant intensity every hour, so that radiant intensity of these optic regulators reach to its radiant proxy at 12:00 o’clock which means 400 lox for each regulator device, and subsequently reducing their radiant intensity at a rate about 68 lox an hour, and at a result, the light would have been turned off at 6 o’clock PM, almost conformed with approximate time of the sunset.
Category
Prevention

2

Description
Control group: the control group continued their experience with constant artificial light during the same time period. After this time, the study variables were reanalyzed and compared to the baseline values.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Marine Forces
Full name of responsible person
Majid Hazrati
Street address
Marin Force
City
Bandarabas
Province
Hormozgan
Postal code
1435916471
Phone
+98 21 8248 2148
Email
majidhazrti@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Hassan Saadat
Street address
Sheikh Bahaie st. Mollasadra Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2148
Email
saadat350@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Khodabakhsh Ahmadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sheikhbahaie St. Mollasadra Ave.
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2712
Fax
Email
kh_ahmady@bmsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Khodabakhsh Ahmadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sheikhbahaie St. Mollasadra Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2712
Fax
Email
kh_ahmady@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Khodabakhsh Ahmadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sheikh bahaie st. Mollasadra ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2148
Email
kh_ahmady@bmsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Article is publishedWill be published in paper.
When the data will become available and for how long
2018
To whom data/document is available
Researchers and academics
Under which criteria data/document could be used
It is possible to mention the source of the research article
From where data/document is obtainable
An article that will be published will be available.
What processes are involved for a request to access data/document
An article that will be published will be available.
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