Trials (Apr 2022)
Effect of electroacupuncture on discomfort during gastroscopy: a study protocol for a randomized controlled trial
Abstract
Abstract Background Gastroscopy procedures are frequently performed under general sedation to minimize discomfort. Patients who refuse a sedative injection may experience more discomfort and adverse reactions such as pain and nausea. These instances reduce patient compliance and willingness to participate in future procedures. Acupuncture has been shown to have an anti-nausea and analgesic effect; however, there is limited data available that demonstrates the efficacy of acupuncture when applied before gastroscopy. Methods A total of 60 participants will be randomly assigned to the electroacupuncture (EA) group and the sham electroacupuncture (SEA) group at a ratio of 1:1. Acupuncture treatment will be performed before gastroscopy for a duration of 30 min. All patients will complete detailed questionnaires at 30 min and 7 days post-procedure to record the severity of their symptoms. The primary outcome will be the average of 4 standard visual analogue scale (VAS) scores in the categories of nausea, vomiting, throat discomfort, and agitation as reported by the patient. The secondary outcomes will be patient’s anxiety level as recorded by the 6-item short form of the State-Trait Anxiety Inventory (STAI-S6) and Amsterdam Pre-Operative Anxiety and Information Scale (APAIS), preference in a future endoscopy, pulse oxygen saturation (SpO2), heart rate (HR), and blood pressure (BP). Anxiety scales will be assessed before and after acupuncture; others will be completed at 30 min and 7 days post-procedure. The duration of the gastroscopy and the number of biopsies will be recorded after operation. Discussion This randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the improvement of patient discomfort during gastroscopy without systemic sedation. Trial registration ChiCTR2000040726 . This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2020SHL-KY-11). Registration date 12 August 2020.
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