Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499662
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-07-07
Brief Title:
Randomised Clinical Trial to Determine the Effect of Vagus Nerve Neurodynamics on the Neurovegetative Nerve System in People With Chronic Stress
Sponsor:
Marta de la Plaza
Organization:
European University of Madrid
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VNN-HRV-CCS
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None