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IRCT20220614055175N1 IRCT 2022-12-12 Shahid Beheshti University of Medical Sciences Therapeutic effects of low-level laser therapy in reducing of cognitive symptoms, anxiety and depression in patients with mild and moderate dementia Compared with the control group effect of laser therapy in reducing of cognitive symptoms, anxiety and depression in patients with mild and moderate dementia 2022-11-22 anticipated 24 Complete https://irct.ir/trial/66581 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization is done as block randomization for 24 people. If A is for treatment and B is for control, first we define 6 combinations with equal allocation as follows: 1=(ABBA) 2=(ABAB) 3=(AABB) 4=(BABA) 5=(BBAA) 6=(BAAB) Then, using the table of random numbers from 1 to 6, six numbers are selected and based on the numbers selected from the list above, we determine the order of the patient or the control, Blinding description: Each patient is assigned a code at the beginning of the study, which will be known by that code until the end of the study. This study was conducted in a double-blind manner, so that the patients, doctors, and clinical caregivers and the data analyzer are not aware of the groupings and only the third party, who is the psychologist of the department It will group people and evaluate relevant questionnaires before and after treatment. N/A Dementia. Intervention 1: Intervention group: This group will be formed by patients who receive PBM (photobiomudulation) as an auxiliary treatment for two weeks and their information is based on age, sex, level of education, marital status and duration of disease onset, cognitive symptoms and depression and anxiety level are noted by the relevant questionnaires and they are treated with low power laser for 2 weeks and 3 sessions every week. The level of depression, anxiety and cognitive symptoms are evaluated again by questionnaire at the end of the treatment and one month after the last treatment when visiting the clinic and the before and after results are compared between the 2 groups. Intervention 2: Control group: The people of the second group will be selected as the same control group as the first group. Cognitive symptoms, level of depression and anxiety are evaluated by a questionnaire at the beginning of the treatment, at the last session of the treatment and one month after the last treatment at the clinic and the before and after results are compared between the 2 groups. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after de-identifying individuals When: Access starts 6 months after the results are published To whom: All researchers working in academic and scientific institutions, doctors and pharmaceutical companies will be allowed to access the information Conditions: The applicant can access the information after providing proof of identity Where to obtain: Applicants can contact Dr. Somayeh Jarrahi by email to receive the desired documents or data.jarrahi1364@gmail.com How to obtain: The applicant can communicate with the researcher through email and receive the basic data after presenting the identity documents Comments:
public Somayeh Jarrahi
Sarshar dormitory number 12,sarshar dead end alley,Valiasr street
Tehran Iran (Islamic Republic of) 1961835484 +98 21 2272 1367 jarrahi1364@gmail.com Shahid Beheshti University of Medical Sciences scientific علی خردمند
Taleqani hospital, Student Blvd ,Valenjak
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 dr.alikheradmand@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with with mild and moderate dementia who have been diagnosed for at least two years Age over 65 years. Both genders 65 years no limit Both Patients with a history of major psychatric disorder clastrophobia substance use benzodiazepin use People who have significant changes in symptoms and drug regimen in the last 6 months history of sever traumatic brain injury F03 Unspecified dementia Treatment - Devices Treatment - Devices Intervention group: This group will be formed by patients who receive PBM (photobiomudulation) as an auxiliary treatment for two weeks and their information is based on age, sex, level of education, marital status and duration of disease onset, cognitive symptoms and depression and anxiety level are noted by the relevant questionnaires and they are treated with low power laser for 2 weeks and 3 sessions every week. The level of depression, anxiety and cognitive symptoms are evaluated again by questionnaire at the end of the treatment and one month after the last treatment when visiting the clinic and the before and after results are compared between the 2 groups. Control group: The people of the second group will be selected as the same control group as the first group. Cognitive symptoms, level of depression and anxiety are evaluated by a questionnaire at the beginning of the treatment, at the last session of the treatment and one month after the last treatment at the clinic and the before and after results are compared between the 2 groups. Depression. Timepoint: Before and after treatment. Method of measurement: Geriatric depression Scale questionnaire. Anxiety. Timepoint: Before and after treatment. Method of measurement: Hamilton anxiety questionnaire. Cognitive symptom. Timepoint: Before and after treatment. Method of measurement: minimal mantal status examination. Shahid Beheshti University of Medical Sciences Approved 2022-10-23 Ethics Committee of Shahid Beheshti University of Medical Sciences Taleghani Hospital,kodakyar Street , Student Blvd ,Valenjak Tehran Tehran Iran (Islamic Republic of)