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IRCT20240713062416N1 IRCT 2024-07-18 Islamic Azad University Semnan branch Effectiveness of repeated transcranial magnetic stimulation on sleep quality, emotional disturbance and severity of disorder symptoms in patients with emotional disorders Effectiveness of repeated transcranial magnetic stimulation on sleep quality, emotional disturbance and severity of disorder symptoms in patients with emotional disorders 2024-07-24 anticipated 60 Complete https://irct.ir/trial/77957 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are randomly assigned to intervention and control groups using the random block method. First, a number is assigned to each sample person. Then the numbers are written on paper, folded and thrown into a container. The papers are thoroughly mixed and removed one by one. Accordingly, one number is assigned to the first group and one number to the second group. For randomized use, one group is known as the "control group" and the other group is known as the "intervention group" by drawing lots. To randomly determine "control group" and "intervention group", we put the set of numbers of each group in two separate envelopes and put these envelopes in a container. Then we randomly take one envelope out of the container and assign it to the "intervention group" and the other envelope to the "control group". This method ensures that the allocation of patients to groups is done completely randomly and without bias, Blinding description: Because the patients do not know about the group assignment, the study is performed in a blinded manner. N/A Behavioral and emotional disorders. Intervention 1: Intervention group: This research will be conducted on patients with emotional disorders and the intervention will include 20 sessions (regularly on 5 days of the week). The experimental group was treated with transcranial magnetic stimulation from the usual protocol used in clinics, which includes a frequency of 10 Hz, a duration of stimulation of 5 seconds, an interval between each stimulation of 25 seconds, 120% movement threshold, and a stimulation location equal to f3 area in the 10-20 system. or LDLPFC and the duration of stimulation is 20 minutes. Intervention 2: Control group: They will receive rTMS in a silent mode. No - There is not a plan to make this available Justification or reason for not sharing IPD is Since the research plan is related to a thesis, only the study protocol, clinical study report, and study results will be published. The participant data file contains information about the participants, and due to the preservation of individuals' privacy it cannot be published.
public Fatemeh Sohrabi
5th floor, No. 5, East Second Alley, Akakia Street, Mobarez East Street, Abu Dharr Blvd
Tehran Iran (Islamic Republic of) 1778833386 +98 21 3364 5489 fsohrabi.master@gmail.com Islamic Azad University Semnan branch scientific Maryam Izadi Mazidi
Islamic Azad University, University Town, Semnan
Semnan Iran (Islamic Republic of) 3513137111 +98 23 3365 4040 maryam.izadi.psy@gmail.com Islamic Azad University Semnan branch Iran (Islamic Republic of) Patients must be certified by a psychiatrist or psychologist based on DSM-5 or ICD-10 diagnostic criteria. The age range of participants should be between 18 and 65 years. Patients must have moderate to severe symptom severity as assessed using validated instruments such as the Beck Depression Scale (BDI), Hamilton Anxiety Scale (HAM-A), or similar instruments. Patients must sign informed consent and be willing to participate in all repeated transcranial magnetic stimulation sessions and related assessments. Patients who are currently receiving medication or psychotherapy should have stable treatment and not have any major changes in their treatment for at least 4 weeks before the start of the study. Patients must have significant problems in sleep quality and emotional disturbances that affect their quality of life and daily performance. 18 years 65 years Both Patients diagnosed with other psychiatric disorders such as psychotic disorders, bipolar disorders or substance abuse disorders in the period of 6 months before the start of the study. Taking medications that may interfere with transcranial magnetic stimulation, such as anticonvulsants or antipsychotics. Patients with serious physical problems such as cardiovascular disease, renal or hepatic failure, or serious neurological disease that may interfere with the treatment protocol. Patients with metal implants in the head or neck area (such as implanted hearing aids) that may be stimulated by magnetic fields. Pregnant or lactating women due to unknown risks to the fetus or infant. Patients who do not attend or follow instructions for repeated transcranial magnetic stimulation sessions or follow-up assessments. Patients who decide to withdraw from the study at any stage of the research and do not want to continue. F98 Other behavioral and emotional disorders with onset usually occurring in childhood and adolescence Treatment - Devices Treatment - Devices Intervention group: This research will be conducted on patients with emotional disorders and the intervention will include 20 sessions (regularly on 5 days of the week). The experimental group was treated with transcranial magnetic stimulation from the usual protocol used in clinics, which includes a frequency of 10 Hz, a duration of stimulation of 5 seconds, an interval between each stimulation of 25 seconds, 120% movement threshold, and a stimulation location equal to f3 area in the 10-20 system. or LDLPFC and the duration of stimulation is 20 minutes. Control group: They will receive rTMS in a silent mode. Sleep quality. Timepoint: Before intervention and after 20 intervention sessions. Method of measurement: Pittsburgh Sleep Quality Questionnaire (PSQI). Emotional disturbance. Timepoint: Before intervention and after 20 intervention sessions. Method of measurement: Emotional disturbance questionnaire (DASS21). Severity of disorder symptoms. Timepoint: Before intervention and after 20 intervention sessions. Method of measurement: Clinical General Impression Questionnaire (CGI). Islamic Azad University Semnan branch Approved 2024-05-21 Ethics committee of Semnan Azad University Islamic Azad University, University Town, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)