From: Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial
 | Item | Detail |
---|---|---|
1. Acupuncture Rationale | 1a) Style of acupuncture | EA based on traditional medicine theory |
1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate | Textbook on acupuncture and Moxibustion, related literature [10–12, 43], consensus by experts in acupuncture and insomnia | |
1c) Extent to which treatment was varied | Standardized treatment | |
2. Details of acupuncture | 2a) Number of needle insertions per subject per session | Fixed 10 acupoints |
2b) Names of points used | EA treatment group: Unilateral GV20, EX-HN3, bilateral HT7, PC6, BL63, KI4 | |
2c) Depth of insertion | From 5 to 20Â mm | |
2d) Response sought | de qi during needling and perception of stimulus during electrostimulation | |
2e) Needle stimulation | After manual stimulation, 4Â Hz will be conducted and stimulation will be at 80% intensity of the stimulus the participant perceives | |
2f) Needle retention time | 30Â min | |
2 g) Needle type | 0.25 × 40 mm sterilized stainless steel needle | |
3. Treatment regimen | 3a) Number of treatment sessions | Total 10 sessions |
3b) Frequency and duration of treatment sessions | 2–3 sessions per week for 4 weeks | |
4. Other components of treatment | 4a) Details of other interventions administered to the acupuncture group | All three groups will be educated through sleep hygiene brochure. Usual care group will be permitted to have any type of treatment |
4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients | The practitioner will limit unnecessary conversation that does not pertain to the treatment or patient | |
5. Practitioner background | Description of participating acupuncturists | Korean Medical Doctors who have a license and at least 2Â years of clinical experience |
6. Control or comparator intervention | 6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choice | Park sham placebo device will be used as a sham control [12, 14] |
6b) Precise description of the control or comparator. If sham acupuncture or any other type of acupuncture-like control is used, provide details as for items 1–3 above. | SEA control group: use Park sham placebo device on 10 non-acupoints on both upper and lower limb and connect the electrostimulator in switch-off state for removal after 30 min |