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Electroacupuncture for treating insomnia clinical trial

Not Applicable
Recruiting
Conditions
Mental and behavioral disorders
Registration Number
KCT0001685
Lead Sponsor
Korea Institute of Oriental Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
150
Inclusion Criteria

1. are aged between 19 and 65 years
2. Insomnia Severity Index are scored = 15
3. be satisfied insomnia disorder diagnosis of Diagnostic and Statistical Manual of Mental Disorders-5(DSM-5)
4. agreed with written informed consent

Exclusion Criteria

1. were taking herbal remedies, over-the-counter medications, or psychotropic drugs that were intended for the treatment of insomnia within the last 2 weeks prior to baseline or during the study or were chaged of kind, dosage that taking regular medication within 4 weeks
2. were diagnosed to with a concurrent major depressive disorder, generalized anxiety disorder, panic disorder, manic or hypomanic episode, substance use disorder besides caffeine or nicotine use, organic mental disorder, schizophrenia, or depression part of HADS(Hospital Anxiety and Depression Scale) were scored = 11
3. impacted life cycle by shift work or changed day or night working time
4. had serious physical pain or illnes caused insomnia
5. had valvular heart defects or bleeding disorders or were taking anticoagulant drugs
6. were doubtful of uncontrol hormone disease, serious illness, whole body illness that can affect insomnia by blood test
7. known hypersensitivity reaction after acupuncture treatment or inability to cooperate with acupuncture procedure
8. known hypersensitivity reaction after electroacupuncture treatment or had in body unsuitable prosthesis for electroacupuncture
9. pregnant, expecting pregnant or nursing women
10. difficult for adaptation that treatment, visit, answer a survey
11. those who are not willing to comply with this study protocol

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Insomnia Severity Index;Insomnia Severity Index
Secondary Outcome Measures
NameTimeMethod
Pittsburgh Sleep Quality Index;Hospital Anxiety and Depression Scale;Sleep Diary;EuroQol-5 dimension ;Melatonin & Cortisol Study ;Patient Global Impression of Change ;Adverse events
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