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

NCT ID: NCT06970769

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-29
• Study Completion Date: 2025-04-30

Brief 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.

Detailed 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.

Conditions

Mother of a Child With Cerebral Palsy

Study Design

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

Study Groups

Auricular Nerve Stimulation

The auricular branch of the vagus nerve can be superficially stimulated from the external ear by non-invasive access. This method is applied without any surgical procedure by means of TENS add-on devices. This technique, which is widely used in epilepsy, pain and headache, increases the intensity of pain and reduces mechanical sensitivity.

Group Type: EXPERIMENTAL

Vagus nerve stimulation

Intervention Type: OTHER

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.

Deep breathing exercise

Deep breathing exercise aimed to improve stress, sleep problems and physiological balance by increasing parasympathetic activity on the autonomic nervous system of mothers in our study. Diaphragmatic breathing technique was taught to participants who applied deep breathing exercise in a comfortable position. Exercises were planned to be performed with a certain rhythm of inspiration and expiration times. Participants were trained with repetitions so that they could continue the application at home. The exercises were applied regularly in the home environment for the specified period.

Group Type: EXPERIMENTAL

Deep Breathing Exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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 Criteria

• Providing care for an elderly, chronically ill or disabled relative;
• Having a history of chronic disease such as diabetes, cardiovascular or pulmonary disease, 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Atlas University

OTHER

Sponsor Role: lead

Responsible Party

Gamze Demircioğlu

Asst. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İstanbul Atlas University

Istanbul, Kağıthane, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2025-ATLAS-MSEHF-003

Identifier Type: -

Identifier Source: org_study_id