Investigation of TVNS Administration on Postpartum Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- transcutaneous vagus nerve stimulation
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
University Hospital Tuebingen
Lead sponsor
German Center for Mental Health
Collaborator
Source ClinicalTrials.gov