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IRCT20190706044118N1 IRCT 2020-01-12 Tehran University of Medical Sciences Effect of phototherapy on depression and sleep quality during pregnancy The effect of bright light therapy on depression and sleep quality during pregnancy 2019-07-23 anticipated 70 Complete https://irct.ir/trial/40614 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Depression. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Dr. Seyedeh Fatemeh Vasegh Rahimparvar
School of Nursing and Midwifery, Dr Mirkhani Ave (Eastern Nusrat), Tohid Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6694 1669 vaseghrh@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Seyedeh Fatemeh Vasegh Rahimparvar
School of Nursing and Midwifery, Dr Mirkhani Ave (Eastern Nusrat), Tohid Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6694 1669 vaseghrh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 35 years Female 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 f32 Major depressive disorder, single episode, mild Treatment - Devices Treatment - Devices 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. 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. Depression score in Beck Questionnaire. Timepoint: Before the study, immediately and 4 weeks after the end of intervention. Method of measurement: Beck Depression Inventory. 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. Tehran University of Medical Sciences Approved 2019-06-25 Schole of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Science School of Nursing and Midwifery, Dr Mirkhani Ave (Eastern Nusrat), Tohid Square Tehran Tehran Iran (Islamic Republic of)