Effect of acupuncture on anxious symptoms in healthcare students with generalized anxiety disorder: A protocol for a randomized controlled clinical trial

BackgroundThe present study aimed to investigate the effect of acupuncture on generalized anxiety disorder (GAD) in healthcare students. On the basis of increasing prevalence of anxiety disorders in this population and the research gap regarding the use of acupuncture as a therapeutic intervention, this study aims to fill this gap and provide solid evidence on the effectiveness and safety of this practice. MethodsThe methodology will include a single-center, single-blinded, randomized, placebo-controlled clinical trial. A total of 87 patients diagnosed with generalized anxiety disorder will be enlisted and randomized to either manual acupuncture or sham acupuncture. Participants in both arms will undergo 30 minute-sessions once weekly until 10 sessions are completed over 4 months. The primary outcome measure will be assessed via 3 scales validated for Brazil: Generalized Anxiety Disorder Scale (GAD-7), The Beck Anxiety Inventory (BECK-A), The Penn State Worry Questionnaire (PSWQ) at baseline, 5 weeks and 10 weeks. All adverse events will be meticulously recorded and categorized by their time of onset and resolution, with appropriate clinical assessments provided for each patient. DiscussionAcupuncture is expected to significantly reduce anxiety symptoms in participants. The results of this study will contribute to the evidence on the effectiveness and safety of acupuncture in treating anxiety in healthcare students, providing data that may influence clinical practices and future treatment guidelines. Trial RegistrationThe Brazilian Registry of Clinical Trials: RBR-9stskc6. Registered 4 December 2024