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Transcutaneous Auricular Vagus Nerve Stimulation as an Augmentation Method for Psychosomatic Multimodal Treatment: A Randomized Controlled Study

Transcutaneous Auricular Vagus Nerve Stimulation as an Augmentation Method for Psychosomatic Multimodal Treatment: A Randomized Controlled Study - TAVUS Station

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036182
Enrollment
90
Registered
2025-06-06
Start date
2025-06-09
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F45

Interventions

Group 1: Intervention group receiving active transcutaneous vagus nerve stimulation (tVNS) as an augmentation strategy to a multimodal psychosomatic-psychotherapeutic complex treatment (duration: 6–12

Sponsors

Universitätsmedizin Magdeburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ICD-10 Diagnosis F45.- Adults aged 18 and older who are undergoing inpatient treatment for a somatoform disorder (F45.-) Written consent Fluent knowledge of German

Exclusion criteria

Exclusion criteria: Severe psychiatric disorder according to ICD-10 (F00-F09, F20-F29, substance use disorders) Pain or injuries in or around the ears Implanted pacemaker Acute risk of harm to self or others Inability to provide consent

Design outcomes

Primary

MeasureTime frame
Primary outcome parameters refer to pain intensity (McGill Pain Questionnaire, NRS), somatic symptoms (SSD-12), and psychological comorbidities (PHQ-9, GAD-7, WHO-5, CTQ)—

Secondary

MeasureTime frame
As a secondary outcome parameter, the subjective acceptance of the intervention (ZUF-8) will be assessed, along with resources (resilience, self-efficacy).—

Countries

Germany

Contacts

Public ContactCaroline Rometsch

Universitätsmedizin Magdeburg

caroline.rometsch@med.ovgu.de+493916714200

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026