Tokyo, Nov. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059838) titled 'Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Continuous Deep Breathing/Aerobic Exercise on Pain Inhibition' on Nov. 22.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Graduate School Niigata University of Health and Welfare, Graduate School of Medical and Welfare Studies

Condition: Condition - Chronic pain Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Chronic pain is a serious global issue, and traditional treatments have limitations such as the need for specialized guidance and the risk of side effects. Therefore, simple approaches that increase neurotransmitters, such as deep breathing and aerobic exercise, have gained attention. Deep breathing activates the brain via the vagus nerve, but its effects tend to be unstable. In contrast, combining it with transcutaneous auricular vagus nerve stimulation (taVNS) may stabilize vagal activity and enhance pain-relieving effects. Aerobic exercise suppresses pain through endogenous opioids, but individuals with chronic pain may find it difficult to continue due to autonomic dysfunction and other factors. However, combining aerobic exercise with taVNS may help maintain autonomic and cognitive function. The aim of this study is to compensate for the limitations of deep breathing and exercise and to examine whether combining them with taVNS can produce stable analgesic effects. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants will perform deep breathing for 10 minutes per day for 14 days while receiving transcutaneous auricular vagus nerve stimulation on the cymba conchae (continuous deep breathing and active taVNS). Interventions/Control_2 - Participants will perform deep breathing for 10 minutes per day for 14 days while receiving transcutaneous auricular vagus nerve stimulation on the earlobe (continuous deep breathing and sham taVNS).

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Healthy undergraduate or graduate students Key exclusion criteria - Individuals with a personal or family history of epilepsy, anxiety disorders, or cardiovascular disease, Pregnant individuals, Individuals experiencing pain, Individuals who exercise three or more times per week Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 15 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068431

Disclaimer: Curated by HT Syndication.