None listed
Conditions
Interventions
Medical Device : Participants will be randomly assigned to one of the three groups: electroacupuncture treatment group, sham control group, or usual care group. The two former groups will receive 10 s
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both male and female, aged 19 or over, but under 80 years 2. The Eastern Cooperative Oncology Group (ECOG) performance status = 2 3. Cessation of cancer-related treatments (e.g. surgery, radiotherapy, chemotherapy, immunotherapy) at least 12 weeks before the trial (except for on-going hormone therapy, which must have been initiated at least 3 weeks prior to enrollment) 4. Continuous insomnia related to cancer treatment or cancer itself for at least 3 months, fulfilment of The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder 5. Total score in the Insomnia Severity Index (ISI) = 15 points 6. Willingness to participate in the trial and provide written consent
Exclusion criteria
Exclusion criteria: 1. Current level of sleep disorder even before the diagnosis of cancer 2. Severe anemia (platelet count 5.1 uIU/ml) 15. A previous hypersensitivity reaction to acupuncture or difficulty cooperating with acupuncture therapy 16. The presence of implants that could interfere with electroacupuncture or a history of hypersensitivity to electrostimulation 17. Pregnancy, lactation, or planning a pregnancy 18. Having participated in other clinical trials in the previous 4weeks 19. Difficulty complying with the treatment, questionnaire, or study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of total scores in the Insomnia Severity Index (ISI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change of total scores in the ISI;Mean change of total scores in the Pittsburgh Sleep Quality Index (PSQI);Mean change of total scores in the Korean version of Montreal Cognitive Assessment (MoCA-K);Mean change of total scores in the Functional Assessment of Cancer Therapy-Fatigue (FACT-F);Quality of sleep measured by sleep diary;Quality of sleep measured by actigraph;Salivary melatonin and cortisol;Adverse event ;Blinding test ;Credibility questionnaire | — |
Countries
Korea, Republic of
Contacts
Public ContactJoo-hee Kim
Korea Institute of Oriental Medicine
Outcome results
None listed