Actively Recruiting
Investigation of TVNS Administration on Postpartum Mental Health
Led by University Hospital Tuebingen · Updated on 2024-11-12
120
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
G
German Center for Mental Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation of TVNS Administration on Postpartum Mental Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No malformation of fetal organs detected during organ screening
- Ability to provide written consent
- Sufficient German language skills to understand and communicate during the study
You will not qualify if you...
- Pregnant women or those with active implants such as cochlear implants or pacemakers
- Presence of cerebral shunts or skin problems
- Cardiovascular issues including cardiac arrhythmias or coronary heart disease
- Neurological disorders
- Current mood disorder diagnosis or episode
- Diagnosed schizophrenia spectrum or other psychotic disorders
- Severe substance use disorders
- Other health issues that may pose a risk to the participant or child as determined by the study clinician
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Tuebingen; Department of Psychiatry and Psychotherapy
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
Research Team
J
Julia Siodmiak, M.sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
3
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