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

NCT ID: NCT06499662

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-23
• Study Completion Date: 2024-07-07

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vagus Nerve Neurodynamics and Guided Breathing with Manual Therapy

Participants in this arm will receive a combination of vagus nerve neurodynamics and guided breathing at a rate of 6 breaths per minute (bpm), along with manual therapy. The neurodynamics intervention involves passive movements in the cervical region to enhance vagus nerve function, synchronized with the guided breathing. The manual therapy will include suboccipital inhibition techniques to complement the intervention. The total duration of the intervention will be 15 minutes.

Group Type: ACTIVE_COMPARATOR

Vagus Nerve Neurodynamics

Intervention Type: OTHER

This intervention involves passive cervical movements designed to enhance vagus nerve functionality.

Guided Breathing

Intervention Type: OTHER

This intervention consists of diaphragmatic breathing guided by a recording to maintain a rate of 6 breaths per minute.

Manual Therapy

Intervention Type: OTHER

This intervention includes suboccipital inhibition techniques applied during the session.

Guided Breathing with Manual Therapy

Participants in this arm will receive only guided breathing at a rate of 6 breaths per minute (bpm) along with manual therapy. The guided breathing will be diaphragmatic, following a recording that marks the times for inhalation and exhalation. The manual therapy will include suboccipital inhibition techniques applied during the breathing. The total duration of the intervention will be 15 minutes.

Group Type: ACTIVE_COMPARATOR

Guided Breathing

Intervention Type: OTHER

This intervention consists of diaphragmatic breathing guided by a recording to maintain a rate of 6 breaths per minute.

Manual Therapy

Intervention Type: OTHER

This intervention includes suboccipital inhibition techniques applied during the session.

Interventions

Vagus Nerve Neurodynamics

This intervention involves passive cervical movements designed to enhance vagus nerve functionality.

Intervention Type: OTHER

Guided Breathing

This intervention consists of diaphragmatic breathing guided by a recording to maintain a rate of 6 breaths per minute.

Intervention Type: OTHER

Manual Therapy

This intervention includes suboccipital inhibition techniques applied during the session.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: collaborator

Marta de la Plaza

OTHER

Sponsor Role: lead

Responsible Party

Marta de la Plaza

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Marta de la plaza

Madrid, , Spain

Countries

Spain

Other Identifiers

VNNHRV2024-01

Identifier Type: -

Identifier Source: org_study_id