Electroacupuncture for treating insomnia clinical trial
- 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
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
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
Name Time Method Insomnia Severity Index;Insomnia Severity Index
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index;Hospital Anxiety and Depression Scale;Sleep Diary;EuroQol-5 dimension ;Melatonin & Cortisol Study ;Patient Global Impression of Change ;Adverse events