Clinical trial NCT06970769: Effect of Vagus Nerve Stimulation and Breathing Exercise on the Autonomic Nervous System
Official title: Comparison of the Effects of Vagus Nerve Stimulation and Breathing Exercise on the Autonomic Nervous System in Mothers of Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mother of a Child With Cerebral Palsy
Keywords: cerebral palsy
mother
autonomic nerve system
vagus
breathing exercises
depression
pain
sleep quality
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gross motor functional classification (GMFCS)
timeFrame: Baseline (prior to intervention)
measure: beck depression scale
timeFrame: 3 week
measure: Caregiving Burden Scale
timeFrame: 3 week
measure: NORDIC musculoskeletal system questionnaire
timeFrame: 3 week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 week
measure: Autonomic Nervous System Assessment (Polar H10)
timeFrame: 3 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Atlas University
state: Kağıthane
Study officials:
References: