Protocol summary

Study aim
Determining the effect of bright light therapy on depression and sleep quality during pregnancy
Design
Clinical trial with control group, community based and pragmatic, with parallel, double blind, and randomized groups
Settings and conduct
The place of the study was the selected health service centers affiliated to Tehran University of Medical Sciences, such as Akbarabad, Ayat, Farmanfarmai’yan and Imam Mohammad Bagher clinics. Samples will be assigned to one of the two groups, intervention or control, by simple randomization or drawing. Before the study starts, participants are informed that they are randomly assigned to one of two groups, intervention or control. Due to the similarity of the lamps used in intervention or control groups, the researcher, participants, evaluator and data analyzer may not detect the types of lamps, and only the designer and manufacturer of the lamps can distinguish them.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18–35 years of age, 14–28 weeks pregnant, mild depression and moderate depression from Beck Depression Inventory. exclusion criteria:History of any known medical and obstetric complications of pregnancy, History of known chronic diseases and other psychiatric disorders, History of hospital admission due to known psychological problems, History of known ocular diseases and eye surgery in a recent year.
Intervention groups
The intervention group received therapy with the bright light (9000 lux) and the control group with the dark red light (100 lux) during the first 30min after waking up at the morning for 5 weeks. This light is emitted from light boxes, which include a frame, stand and LED lamps. These equipments are purchased from Aj Teb Co. and designed and manufactured by a member of the research team
Main outcome variables
Depression Score, Sleep Quality Score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190706044118N1
Registration date: 2020-01-12, 1398/10/22
Registration timing: registered_while_recruiting

Last update: 2020-01-12, 1398/10/22
Update count: 0
Registration date
2020-01-12, 1398/10/22
Registrant information
Name
Omecolsom Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7728 5091
Email address
fatemehazizi18965@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of bright light therapy on depression and sleep quality during pregnancy
Public title
Effect of phototherapy on depression and sleep quality during pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18–35 years of age 14–28 weeks pregnant Single-fetal pregnancy Spontaneous pregnancy Score of 10_17 (mild depression) and score of 18 _29 (moderate depression) frome Beck depression inventory
Exclusion criteria:
History of any known medical and obstetric complications, such as gestational diabetes, placenta previa, placental apruptio or preeclampsia in the present pregnancy History of other known psychiatric disorders such as bipolar disorder History of hospital admission due to known psychological problems History of known chronic diseases such as epilepsy History of known ocular diseases History of eye surgery in a recent year History of using antidepressants in the past 2 months Recent history of suicide attempt Having Shift-work (Morning and Night Shifts) History of Previous bright light therapy Having drug addiction, smoking, alcohol and psychotropic substances The occurrence of any horrible event during the last 6 months
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples were under intervention or control through simple randomization in one of two groups. Simple randomization is performed individually by simple drawing and randomization unit, in such a way that 35 numbers from 1 to 70 are randomly selected and assigned to the intervention group and the rest of the numbers will be assigned to the control group. .
Blinding (investigator's opinion)
Double blinded
Blinding description
Before the study starts, participants are informed that they are randomly assigned to one of two groups, A or B, and also that they may be treated with a illuminant light (9000 LUX), which, according to some studies, have been effective in treating depressive symptoms, or weak light (100LUX). Due to the similarity of the lamps used in Groups A and B, the researcher, participants, evaluator and data analyzer may not detect the types of lamps, and only the designer and manufacturer of the lamps, i.e. Mr. Radfar (Ph.D. in Medical physics) can distinguish between the lamps. All of the above have been addressed in the Ethical Committee, and considering all of these aspects, the Code of Ethics has been issued, which is attached to the relevant section
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Schole of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Science
Street address
School of Nursing and Midwifery, Dr Mirkhani Ave (Eastern Nusrat), Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.TUMS.FNM.REC.1398.058

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
f32
ICD-10 code description
Major depressive disorder, single episode, mild

Primary outcomes

1

Description
Depression score in Beck Questionnaire
Timepoint
Before the study, immediately and 4 weeks after the end of intervention
Method of measurement
Beck Depression Inventory

2

Description
sleep quality score in Pittsburgh questionnaire
Timepoint
Before the study, immediately and 4 weeks after the end of intervention
Method of measurement
Pittsburg Standard Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention in this group will be light therapy (9000 lux) for 5 weeks, for 30 minutes daily for the first 30 minutes when they are awake at home. This light is emitted by light boxes, which include a frame, stand and LED lamps. The equipment is purchased from AjTeb Company and designed and manufactured by a member of the research team, Dr. Radfer (Ph.D. in Medical Physics, Optics) and also Laboratory of Research and Technology Center of Tehran University will calculate appropriate distance from the light device to provide light intensity determined in this research with Luxmeter device. The samples will be asked to be placed in front of this device with measured distance.
Category
Treatment - Devices

2

Description
Control group: Interventions in this group will be treated with Dim Red light (100 lux) for 5 weeks, 30 minutes daily for the first 30 minutes when they are awake at home. This light is emitted by light boxes, which include a frame, stand and LED lamps. The equipment is purchased from AjTeb Company and designed and manufactured by a member of the research team, Dr. Radfer (Ph.D. in Medical Physics, Optics) and also Laboratory of Research and Technology Center of Tehran University will calculate appropriate distance from the light device to provide light intensity determined in this research with Luxmeter device. The samples will be asked to be placed in front of this device with measured distance.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbarabad Health Services Center
Full name of responsible person
Ms. Kermanchi
Street address
Next to Former region 10 Education, West Mahbob Mogaz Ave, Navab Ave
City
Tehran
Province
Tehran
Postal code
1353688973
Phone
+98 21 5514 9454
Fax
+98 21 5513 9791
Email
nahidmashhod@gmail.com
Web page address
https://health.tums.ac.ir

2

Recruitment center
Name of recruitment center
Ayate Health Services Center
Full name of responsible person
Mr. Dr. Karimi
Street address
Opposite Shariati Park, Shariati Town, Mahan Street, behind Ghaleh Morghi garrison
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
+98 21 5585 4000
Email
jamal.karimi48@gmail.com
Web page address
https://health.tums.ac.ir

3

Recruitment center
Name of recruitment center
Farmanfarmaeyan Health Service Center
Full name of responsible person
Ms. Dr. Varmarziyary
Street address
In front of meli Bank, It's not reached the crossroads Roshdiyeh, Azerbaijan Street
City
Tehran
Province
Tehran
Postal code
1318618311
Phone
+98 21 6692 8488
Email
R.var89580@gmail.com
Web page address
https://health.tums.ac.ir

4

Recruitment center
Name of recruitment center
Imam Mohammad Bagher Health Service Center
Full name of responsible person
Ms. Dr. Ahadpor
Street address
Behdasht street after school first Alley, Morteza Gard town, Azadegan right, Turn east, Western Azadegan
City
Tehran
Province
Tehran
Postal code
1898664619
Phone
+98 21 5519 3878
Email
azam2000a@Yahoo.com
Web page address
https://health.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Sixth Floor of assistance Research and Technology, Central University Organization, Corner of Qods Ave., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6670 6142
Fax
+98 21 6670 6141
Email
msahrai@sina.tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Fatemeh Vasegh Rahimparvar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Dr Mirkhani Ave (Eastern Nusrat), Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6694 1669
Fax
+98 21 6642 7255
Email
vaseghrh@tums.ac.ir
Web page address
http://fmn.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Fatemeh Vasegh Rahimparvar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Dr Mirkhani Ave (Eastern Nusrat), Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6694 1669
Fax
+98 21 6642 7255
Email
vaseghrh@tums.ac.ir
Web page address
http://fmn.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omecolsom Azizi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Dr Mirkhani Ave (Eastern Nusrat), Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 7728 5091
Fax
Email
fatemehazizi18965@gmail.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
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