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IRCT20230815059151N1 IRCT 2023-10-14 Shahid Beheshti University of Medical Sciences Investigating the effect of low-level laser in reducing obsessive-compulsive symptoms Therapeutic effects of low-level laser therapy in reducing obsessive compulsive disorder symptoms in bipolar patient treatment Compared with the control group 2023-10-23 anticipated 30 Complete https://irct.ir/trial/72085 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The patients and the researcher are blinded in the study and the third party arranges the samples in two groups in such a way that in terms of age and sex, level of education, marital status, duration of the onset of the disease, the amount of previous hospitalization, the type of drug and the equivalent dose, they are almost identical. There is a similar one in another group. This third party will also place the laser device on the patient's head. N/A Obsessive compulsive disorder. Intervention 1: Intervention group: The intervention group will be formed by patients who receive laser therapy as an adjuvant treatment in the first four weeks of outpatient visits. This group is treated with low-power laser for 9 sessions over a period of 4 weeks. 24 semi-conductor lasers with a power of 100 mW are used for laser treatment of patients, which are placed on a helmet. 12 of the lasers have a visible wavelength of 630 nm and the other 12 have a wavelength of 810 nm. The laser beam is pulsed with a frequency of 75 Hz and a duty cycle of 20 percent for 10 to 20 minutes to the scalp area of the patients. According to the diameter of the laser beam on the skull surface of the patients, which is 0.21 cm2, the power density and energy density applied to the patients in each session are 0.9 W/cm2 and 56.5 J/cm2, respectively. Intervention 2: Control group: The control group is treated with a silent laser device with zero intensity in the first 4 weeks of outpatient visits for 9 sessions. Yes - There is a plan to make this available What will be shared: Main outcome information and aggregate data can be shared after de-identifying individuals. When: Immediately after printing the results To whom: All researchers working in academic and scientific institutions and people working in the industry and all those interested Conditions: By observing the ethical principles, it is possible to use the data for future research or other purposes. Where to obtain: By phone or e-mail address (Ali_md07@yahoo.com) with the person responsible for the study How to obtain: Providing explanations for where and how to use data by explaining ethical protocols Comments:
public Ali Faghfouri
Unit 4, No 85, Hayamanesh st, Dabestan, seyyed khandan, Tehran, iran
Tehran Iran (Islamic Republic of) 1631668115 +98 21 8846 9459 ali_md07@yahoo.com Shahid Beheshti University of Medical Sciences scientific Ali Faghfouri
Unit 4, No 85, Hayamanesh st, Dabestan, seyyed khandan, Tehran, iran
Tehran Iran (Islamic Republic of) 1631668115 +98 21 8846 9459 ali_md07@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients undergoing OCD treatment are referred to a psychiatric clinic as outpatients Age above 18 years No claustrophobia Patients should be in drug stabilization for at least 2 months The patient is not psychotic 18 years no limit Both Patients with a history of neurological disease such as epilepsy Having other neurological disorders such as parkinsonism Traumatic brain injury Brain stroke pregnancy Acute and chronic physical illness Cases receiving antidepressant treatment or ECT (convulsive therapy with electroshock). F42 Obsessive-compulsive disorder Treatment - Other N/A Intervention group: The intervention group will be formed by patients who receive laser therapy as an adjuvant treatment in the first four weeks of outpatient visits. This group is treated with low-power laser for 9 sessions over a period of 4 weeks. 24 semi-conductor lasers with a power of 100 mW are used for laser treatment of patients, which are placed on a helmet. 12 of the lasers have a visible wavelength of 630 nm and the other 12 have a wavelength of 810 nm. The laser beam is pulsed with a frequency of 75 Hz and a duty cycle of 20 percent for 10 to 20 minutes to the scalp area of the patients. According to the diameter of the laser beam on the skull surface of the patients, which is 0.21 cm2, the power density and energy density applied to the patients in each session are 0.9 W/cm2 and 56.5 J/cm2, respectively. Control group: The control group is treated with a silent laser device with zero intensity in the first 4 weeks of outpatient visits for 9 sessions. OCD severity based on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Timepoint: Measuring the level of obsessive compulsive disorder before the start of treatment and then at the end of treatment and one month after the last treatment in an outpatient visit to a psychiatric clinic. Method of measurement: Yale-Brown Obsessive Compulsive Scale Questionnaire (Y-BOCS). Shahid Beheshti University of Medical Sciences Approved 2023-06-27 Ethics committee of Shahid Beheshti University of Medical Sciences 6th floor,Building No. 2,Shahid Beheshti University of Medical Science,Shahid Arabi,Yemen St,Shahid Chamran Highway,Tehran Tehran Tehran Iran (Islamic Republic of)