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IRCT20210502051162N1 IRCT 2021-08-25 Shahid Beheshti University of Medical Sciences Therapy with low level Laser therapy in patients under methadone maintenance treatment Therapeutic effects of low level Laser therapy in reducing anxiety, depression, and substance abuse craving in patients under methadone maintenance treatment Compared with the control group 2021-09-06 anticipated 80 Complete https://irct.ir/trial/56050 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups. The randomization tool used will be a table of random numbers. In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 8. In each block, 4 individuals will be in intervention group and 4 will be in control group. A total of 10 blocks will be considered for the study. It will be used to blinding, similar devices without labels and only with code. In the intervention group, patients will be treated with a low level laser device, and in the control group, the device will be on their head, but it will be off, Blinding description: Clinical caregivers and patients will be unaware and blind to the type of treatment. It will be used to hide similar devices, without labels and only with code. In the intervention group, patients will be treated with a low level light device, and in the control group, the device will be on their head, but it will be off. Patients will be aware that they will be randomly assigned to one of the two treatment groups, but will not know which treatment will be offered in that group. Patients will be placed in one of two groups using a random number table. The clinician also knows that patients will be treated in two different ways, but will not know which method will work for each patient. The data collector, analyst and outcome assessor will collect and analyze information based on groups 1 and 2, and will not be aware of the type of treatment provided in the groups. They will be kept blind. N/A Addiction. Intervention 1: Intervention group: This group is treated with low level Laser therapy for 2 weeks and 3 sessions per week. The time of exposure to light is 4 minutes in both places of the forehead. This treatment involves the use of a light emitting diode with a maximum wavelength of 810 nm with a full width of up to 40 nm. Creates radiation of 250 mW/cm2 when applied to 4 mm of skin. Intervention 2: Control group: In this group, the laser device is on their head but it is off. They are placed under the device for 2 weeks and 3 sessions every week. Are placed. The time to stay under the device is 4 minutes in both places of the forehead. Yes - There is a plan to make this available What will be shared: Only part of the data such as information about the main outcome or the like can be shared. When: Access period starts 6 months after the results are published To whom: Our data will only be available to researchers working in academia Conditions: Any statistical analysis is allowed Where to obtain: helia helali 09127103907 heliahelali1990@yahoo.com How to obtain: Upon request, information will be sent via email or phone as soon as possible Comments:
public Helia Helali
Fereshteh, Bosnia-Herzegovina Street, Koohyar Street, Second Dead End, No. 22.Bell 4 East
tehran Iran (Islamic Republic of) 1965715551 +98 21 2205 7254 heliahelali1990@yahoo.com Shahid Beheshti University of Medical Sciences scientific helia helali
Fereshteh, Bosnia-Herzegovina St., Koohyar St., Second Dead End No. 22 4 East
tehran Iran (Islamic Republic of) 1965715551 +98 21 2205 7254 heliahelali1990@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients on methadone treatment who have been in treatment for at least three months Age over 18 years Admission will be regardless of gender or ethnicity 18 years 60 years Both Patients treated with other methods of quitting addiction Methadone maintenance treatment less than 3 months We excluded patients who were not between the ages of 18 and 60 Anyone with a history of psychosis and other psychiatric disorders (bipolar, etc.) A history of violent behavior, a history of moving or attempting suicide in the past F11 Opioid related disorders Treatment - Devices Treatment - Devices Intervention group: This group is treated with low level Laser therapy for 2 weeks and 3 sessions per week. The time of exposure to light is 4 minutes in both places of the forehead. This treatment involves the use of a light emitting diode with a maximum wavelength of 810 nm with a full width of up to 40 nm. Creates radiation of 250 mW/cm2 when applied to 4 mm of skin. Control group: In this group, the laser device is on their head but it is off. They are placed under the device for 2 weeks and 3 sessions every week. Are placed. The time to stay under the device is 4 minutes in both places of the forehead. Anxiety rate. Timepoint: After the end of treatment and one month after the last treatment. Method of measurement: HAM-A Through a questionnaire (Hamilton Anxiety measure scale). Depression rate. Timepoint: After the end of treatment and one month after the last treatment. Method of measurement: HAM-D Through a questionnaire (Hamilton depression measure scale). Opioid craving scale. Timepoint: After the end of treatment and one month after the last treatment. Method of measurement: OCS Through a questionnaire (opioid craving scale). Shahid Beheshti University of Medical Sciences Approved 2021-06-07 Ethics Committee of Shahid Beheshti University of Medical Sciences Tehran, Evin, Shahid Shahriari Square Tehran Tehran Iran (Islamic Republic of)