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

Atlas University

Status: Enrolling

Conditions: Mother of a Child With Cerebral Palsy

Treatments: Other: Deep Breathing Exercises; Other: Vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06970769

2025-ATLAS-MSEHF-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Auricular Nerve Stimulation

Experimental group

Description:

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.

Treatment:

Other: Vagus nerve stimulation

Deep breathing exercise

Experimental group

Description:

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.

Treatment:

Other: Deep Breathing Exercises