The goal of this clinical trial is to explore the therapeutic effect of pulse magnetic therapy system combined with drug therapy on patients with anxiety and insomnia. The main questions it aims to answer are: 1. Whether the pulse magnetic therapy system is benefit on improving insomnia in anxiety patients. 2. This improvement is not due to the placement of the instrument。 Participants will accept pulse magnetic therapy (stimulation/sham stimulation) and accept scale evaluation before and after treatment. Researchers will compare the pulse magnetic stimulation group, sham stimulation group and healthy controls to see if the pulse magnetic stimulation do effect on insomnia of anxiety patients.
Insomnia is the most common symptom of anxiety disorder, which has an important impact on the prognosis of anxiety. Pulse magnetic therapy system, with its advantages of compact, convenient, easy to carry, and not limited by the scene and time, has gradually become a common tool for sleep monitoring and treatment. This study is a multicenter randomized controlled design, including 150 cases in the pulse magnetic stimulation+drug treatment group, 150 cases in the sham pulse magnetic stimulation+drug treatment group and 100 healthy controls. Before and after treatment, the patients were comprehensively measured and evaluated with Insomnia Severity Index (ISI), Hamilton Depression Rating Scale 17 (HAMD), Hamilton Anxiety Rating Scale (HAMA), Pittsburgh Sleep Quality Index (PSQI), Self-Rating Sleep Scale (SSRS), Self-Rating Symptom Scale 90 (SCL-90), Quality of Life Scale (SF-36), and Treatment Adverse Reaction Scale (TESS), and sleep monitoring was conducted at the same time, To explore the therapeutic effect of pulse magnetic therapy system detector combined with drug therapy on patients with anxiety and insomnia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Pulse magnetic therapy SM-II (2019102133903)
Anti-anxiety Drugs
Shame magnetic therapy
Changxing County People's Hospita
Changxing, Zhejiang, China
RECRUITINGLinping First People's Hospital
Linping, Zhejiang, China
RECRUITINGThe Fourth Affiliated Hospital of Zhejiang University School of medicine
Yiwu, Zhejiang, China
RECRUITINGInsomnia Severity Index (ISI)
Insomnia Severity Index total score reduction\>50%, the range of Insomnia Severity Index total score is 0-28.
Time frame: Change value of insomnia severity index (ISI) from baseline in the fourth week of intervention
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