Investigation of TVNS Administration on Postpartum Mental Health

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Nov 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transcutaneous vagus nerve stimulation (tVNS) to see if it can help women manage mood swings and depressive symptoms after giving birth, a time known as the postpartum period. The goal is to find out if tVNS can prevent issues like postpartum depression and anxiety, or help those who are experiencing these symptoms. The study will involve women who have just had a baby and will assess their mental health over the first 12 weeks after delivery.

To be eligible for the trial, participants must be women who have had a healthy pregnancy without serious fetal abnormalities and can understand and communicate in German. They will not be able to participate if they have certain health conditions, like heart problems or current mood disorders. Women who join the study will receive guidance on how to use a tVNS device, and their overall health, stress levels, and other factors will be monitored. This trial aims to provide valuable insights into how this treatment might benefit new mothers during a critical time for their mental health.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • No malformation of fetal organs (no abnormalities detected during "organ screening").
• • Ability to provide written consent for themselves.
• • Sufficient German language skills to communicate and understand study procedures.
• Exclusion Criteria:
• • Exclusion criteria for tVNS use (i.e., pregnancy, active implants such as cochlear implants or cardiac pacemakers, cerebral shunts, skin problems, cardiovascular health issues).
• • Cardiac arrhythmias or coronary heart disease.
• • Neurological disorders.
• • Current diagnosis or episode of a mood disorder.
• • Diagnosed schizophrenia spectrum and other psychotic disorders.
• • Severe substance use disorders.
• • Individual exclusion may also occur based on other health issues if the study clinician determines that participation in the study may pose a disadvantage for the participant or the child.