Table 1 Interventions details by Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) items
From: Effect of acupuncture on patients with insomnia: study protocol for a randomized controlled trial
Item | Details | Intervention |
|---|---|---|
1. Acupuncture rationale | 1a) Style of acupuncture | Traditional needle acupuncture and intradermal acupuncture |
1b) Reasoning for treatment provided based on historical context, literature sources, and/or consensus methods, with references where appropriate | Selected traditional acupuncture points on the 12 meridian system based on the systematic review by Yeung and clinical experiences | |
1c) Extent to which treatment was varied | No variation | |
2. Details of needling | 2a) Number of needle insertions per subject per session (mean and range where relevant) | Five needle insertions per 1 session |
2b) Names (or location if no standard name) of points used (uni/bilateral) | Neiguan (PC6), Sanyinjiao (SP6), Shenmen (HT7), Zhaohai (KI6), Shenmai (BL62), all unilateral. | |
2c) Depth of insertion, based on a specified unit of measurement or on a particular tissue level | Depth of needle insertion was at least 5 to10 mm and intradermal acupunctured was 1 to 2 mm | |
2d) Response sought | De-qi sensation felt by practitioner and subject | |
2e) Needle stimulation | No stimulation and just retention without movement Intradermal acupuncture fixed with skin tape and subjects educated to self finger-press on them at nighttime | |
2f) Needle retention time | Twenty-minute retention for needles, intradermal acupuncture patched 48 to 72 hours until next session | |
2 g) Needle type (diameter, length, and manufacturer or material) | Needles: 0.25 × 40 mm, stainless steel (Dong Bang Medical Co. Ltd, Korea) | |
Intradermal acupuncture: 0.18 × 1.3 × 1.5 mm, stainless steel (Dong Bang Medical Co. Ltd, Korea) | ||
3. Treatment regimen | 3a) Number of treatment sessions | Three sessions |
3b) Frequency and duration of treatment sessions | Three times per week, interval of 1 to 4 days between sessions | |
4. Other components of treatment | 4a) Details of other interventions administered to the acupuncture group | Sleep hygiene education |
4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients | Same practitioner treats every subject at every session in the same outpatient clinic | |
5. Practitioner background | 5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience) | Licensed traditional Korean medicine doctor at the Kyung Hee East-West Neo Medical Center at Gangdong with more than 10 years of acupuncture treatment experience |
6. Control or comparator interventions | 6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choice | Sham acupuncture points |
6b) Precise description of the control or comparison group. If sham acupuncture or any other type of acupuncture-like control is used, provide details as for items 1 to 3 above | Same as intervention group except 2b) and 2d) | |
2b) No acupuncture points located away from acupuncture points at least 10 mm | ||
2d) Without De-qi sensation |