None listed
Conditions
Interventions
Medical Device : A study that compare electroacupuncture treatment efficacy of electroacupuncture, sham electroacupuncture, usual care group.
Treatment regimaen: 2~3times/week for 4weeks, total 10 tim
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Insomnia Severity Index | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Hospital Anxiety and Depression Scale;Sleep Diary;EuroQol-5 dimension ;Melatonin & Cortisol Study ;Patient Global Impression of Change ;Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-Hyo Cho
Daejeon Korean Medicine Hospital of Daejeon University
Outcome results
None listed