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Effect of Vagus Nerve Stimulation and Breathing Exercise on the Autonomic Nervous System

NCT06970769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-07-18

No results posted yet for this study

Summary

This project will compare the effects of intraaural vagus nerve stimulation and deep breathing exercises on the autonomic nervous system in mothers of children with cerebral palsy. This approach will allow researchers to evaluate the effects of these practices on the autonomic nervous system.

The study is planned to include 38 mothers of children with cerebral palsy between the ages of 18-50. Participants will be informed about the purpose of the study and will provide written informed consent to verify voluntary participation. Participants will be randomly assigned to one of two groups: "vagus nerve stimulation" and "deep breathing exercises." Autonomic nervous system, pain, depression, sleep quality, and caregiver burden will be assessed before and after the study.

Conditions

  • Mother of a Child With Cerebral Palsy

Interventions

OTHER

Vagus nerve stimulation

In our study, the auricular branch in the pinna was superficially stimulated with a TENS-based vagustim device for non-invasive vagus nerve stimulation. The application was performed in regular sessions with a physiotherapist according to the recorded protocol. This deactivation aimed at modulation of the autonomic nervous system via the vagus nerve.

OTHER

Deep Breathing Exercises

In the study, the participants who were given deep breathing exercises were taught the correct technique in a semi-sitting position. During the exercises, deep breathing and relaxation periods were applied for certain periods. The respiratory rhythm was arranged as controlled inspiration and expiration. The participants were given an application practice so that they could continue the exercise at home.

Sponsors & Collaborators

  • Atlas University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-29
Primary Completion
2025-03-30
Completion
2025-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970769 on ClinicalTrials.gov