NCT06499662

Randomised Clinical Trial to Determine the Effect of Vagus Nerve Neurodynamics on the Neurovegetative Nerve System in People With Chronic Stress.

The Influence of Vagus Nerve Neurodynamics on Heart Rate Variability Measured With Sensors in Patients Suffering From Chronic Stress: A Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Marta de la Plaza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This unicentric, controlled clinical trial aims to evaluate the effects of vagus nerve neurodynamics and 6 bpm guided breathing, combined with manual therapy, on heart rate variability (HRV) in patients suffering from chronic stress. A total of 62 participants will be randomly assigned into two groups: one receiving guided breathing and neurodynamics with manual therapy, and the other receiving only guided breathing with manual therapy. HRV will be monitored using Polar® H10 sensors. The primary outcome is the change in HRV, measured pre- and post-intervention. The study is ethically approved by the Hospital Clínico San Carlos.

Detailed description

This unicentric, controlled clinical trial investigates the impact of vagus nerve neurodynamics and guided breathing at a rate of 6 breaths per minute (bpm), in conjunction with manual therapy, on heart rate variability (HRV) in patients with chronic stress. The study involves 62 participants who will be randomly allocated into two groups. Group 1 will receive a protocol of guided breathing combined with neurodynamics and manual therapy, while Group 2 will follow a protocol of guided breathing with manual therapy only. Each participant will undergo a 15-minute intervention session where HRV will be continuously monitored using Polar® H10 sensors. The intervention will include guided diaphragmatic breathing at 6 bpm to standardize the respiratory rate across participants, ensuring that HRV measurements reflect the effects of neurodynamics rather than respiratory variations. The neurodynamics technique involves passive movements in the cervical region to enhance the functionality of the vagus nerve, potentially influencing HRV. This technique will be applied during the intervention period, with specific movements synchronized with the participants' respiratory cycle. Prior to the intervention, baseline HRV will be recorded during a 7-minute rest period. Post-intervention HRV measurements will also be taken for 7 minutes while participants remain in a supine position. Data analysis will focus on comparing the HRV changes between the two groups, providing insights into the effectiveness of combining neurodynamics with guided breathing and manual therapy. The study adheres to ethical guidelines and has received approval from the Medical Research Ethics Committee of Hospital Clínico San Carlos

Conditions

• Stress, Psychological Cumulative
• Chronic Disease
• Heart Rate Variability
• Vagal Nerve Stimulation
• Autonomic Nervous System Diseases

Interventions

Type	Name	Description
OTHER	Vagus Nerve Neurodynamics	This intervention involves passive cervical movements designed to enhance vagus nerve functionality.
OTHER	Guided Breathing	This intervention consists of diaphragmatic breathing guided by a recording to maintain a rate of 6 breaths per minute.
OTHER	Manual Therapy	This intervention includes suboccipital inhibition techniques applied during the session.

Timeline

• Start date: 2024-03-23
• Primary completion: 2024-07-07
• Completion: 2024-07-07
• First posted: 2024-07-12
• Last updated: 2024-07-12

Locations

1 site across 1 country: Spain