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

Phase

N/A

Condition

Cerebral Palsy

Treatment

Vagus nerve stimulation

Deep Breathing Exercises

Clinical Study ID

NCT06970769

2025-ATLAS-MSEHF-003

Ages 18-50
Female
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Having a child diagnosed with cerebral palsy
The child must be between 4-18 years old
The mother must be between 18-50 years old
The mother to be studied must be literate

Exclusion

Exclusion Criteria:

Providing care for an elderly, chronically ill or disabled relative;
Having a history of chronic disease such as diabetes, cardiovascular or pulmonarydisease, kidney disease, musculoskeletal disorders or any psychiatric disorder
Caring for another child under the age of two
Having another child at home who needs special health care
Not volunteering to participate in the study

Study Design

Vagus nerve stimulation

November 29, 2024

May 31, 2025

Study Description

The autonomic nervous system plays an important role in maintaining the physiological and psychological balance of individuals. Therefore, irregularities in the autonomic nervous system can negatively affect daily life activities and quality of life. In mothers of children with cerebral palsy, the stress, sleep problems and physical loads brought about by the caregiving process can disrupt the autonomic nervous system functions. In this context, interventions aimed at supporting autonomic balance are gaining importance. This project will compare the effectiveness of intraaural vagus nerve stimulation and deep breathing exercises used in clinical settings on the autonomic nervous system in healthy individuals and will allow researchers to evaluate the effects of these methods on physiological functions.

The study plans 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 confirm 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. Data analysis was performed using SPSS v.26 (SPSS Inc., USA) software. χ² test was applied in the analysis of qualitative variables. For data that did not show a normal distribution or were ordinal, Wilcoxon test was preferred for within-group comparisons, and Mann-Whitney U test was preferred for between-group comparisons. For numerical data that showed a normal distribution, Paired Samples T-Test was used for within-group comparisons, and Independent Samples T-Test was used for between-group comparisons. Effect size values were classified as 'negligible' in the range of 0-0.19, 'small' in the range of 0.20-0.49, 'medium' in the range of 0.50-0.79, and 'large' in the range of 0.80 and above. The significance level was determined as p<0.05 in all statistical tests performed.

Connect with a study center

İstanbul Atlas University
Istanbul, Kağıthane 34040
Turkey
Active - Recruiting

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