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Investigation of TVNS Administration on Postpartum Mental Health

RecruitingNAAges 18 Years - anyFemaleUniversity Hospital Tuebingen
NCT06682689 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of the study is to explore whether transcutaneous vagus nerve stimulation (tVNS) may be effective in preventing mood swings and depressive symptoms in the postpartum phase, as well as serving as a supplementary intervention in cases where mood symptoms develop. The study will investigate the effects of tVNS intervention during the first 12 weeks postpartum. Pregnant women will be recruited for the study, and the intervention will begin shortly after giving birth. Participants will receive different instructions on how to use the tVNS device. Additional parameters such as physiological functions, chronic stress, hormones, environment, and personality traits will also be assessed.

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📋 Eligibility rules (as published)
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.
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What it tests

  • transcutaneous vagus nerve stimulation
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Where

1 site
University Hospital Tuebingen; Department of Psychiatry and Psychotherapy
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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