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

Not Applicable

Completed

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

• Registration Number: NCT06499662
• Lead Sponsor: Marta de la Plaza

Brief 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

Study Timeline

• Study Start: 2024-03-23
• Status Verified: 2024-07
• Primary Completion: 2024-07-07
• Study Completion: 2024-07-07
• Study First Submitted: 2024-07-07
• Study First Submitted QC: 2024-07-07
• Last Update Submitted: 2024-07-07
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Individuals aged 18 years or older.
• Self-perceived chronic stress for at least six months.
• Willingness to provide informed consent and comply with the study procedures

Exclusion Criteria

• Consumption of tea, caffeine, energy drinks, alcohol, or tobacco within two hours prior to the study.
• Significant neck pain or headache.
• Carotid sinus syndrome.
• Pregnancy.
• Recent cervical or cardiac surgery.
• Recent significant trauma.
• Cancer.
• Neurological disorders affecting muscle tone.
• Underlying conditions such as diabetes mellitus or arterial hypertension.
• Use of beta-blockers.
• Arrhythmias or other cardiac diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Heart Rate Variability (HRV)	From the start of the study until 7 minutes post-intervention.	The primary outcome measure is the change in heart rate variability (HRV) from baseline to post-intervention. HRV will be measured using a Polar® H10 sensor band placed on the participants' chest. HRV data will be recorded during a 7-minute period before the intervention (at rest), during the 15-minute intervention, and during a 7-minute period after the intervention (at rest). Specific HRV parameters to be analyzed include RMSSD (Root Mean Square of the Successive Differences), pNN50 (percentage of adjacent NN intervals that differ by more than 50 ms), and high-frequency power (HF power).

Trial Locations

Locations (1)

Marta de la plaza; 🇪🇸 Madrid, Spain