Short-term high-dose postoperative transcutaneous auricular vagal nerve stimulation in patients after orthopedic and gynecological operative intervention for pain reduction and prevention of chronic pain: a randomized controlled pilot study.

Short-term high-dose postoperative transcutaneous auricular vagal nerve stimulation in patients after orthopedic and gynecological operative intervention for pain reduction and prevention of chronic pain: a randomized controlled pilot study. - TaVuS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034812

Enrollment

120

Registered

2024-08-07

Start date

2024-08-16

Completion date

Unknown

Last updated

2026-02-02

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 with active auricular Vagus Nerve Stimulation Group 2: Control group with sham intervention Group 3: Control group with treatment as usual

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Individuals aged 18 years and above undergoing an orthopedic surgery in the orthopedic in-patient department -Individuals aged 18 years and above undergoing a gynecological surgery in the gynecological in-patient department -Written consent -Fluent in German language

Exclusion criteria

Exclusion criteria: -Severe psychiatric illness according to ICD-10 (psychosis, addiction or bipolar disorder, severe cases of chronic pain) -Pain or injuries in the ears -Implanted cardiac pacemaker -Suicidal ideation -Lack of capacity to give consent -Heart failure -Cardiac arrhythmia

Design outcomes

Primary

Measure	Time frame
Severity of pain measured by NRS-ratings	—

Secondary

Measure	Time frame
Bodily distress measured by the Somatic Symptom Disorder – B Criteria Scale (SSD-12), mental comorbidities especially stress-associated symptoms of depression (PHQ-9), anxiety (GAD-7) and well-being (WHO-5), the use of analgesics (pharmakon and dosages), the time spent in the hospital post-surgery as well as the subjective acceptability of the intervention. Furthermore, this study aims to exploratively investigate the associations between illness representations and behaviors, as well as traumatic life experiences, in relation to the primary outcome.	—

Measure

Time frame

Bodily distress measured by the Somatic Symptom Disorder – B Criteria Scale (SSD-12), mental comorbidities especially stress-associated symptoms of depression (PHQ-9), anxiety (GAD-7) and well-being (WHO-5), the use of analgesics (pharmakon and dosages), the time spent in the hospital post-surgery as well as the subjective acceptability of the intervention. Furthermore, this study aims to exploratively investigate the associations between illness representations and behaviors, as well as traumatic life experiences, in relation to the primary outcome.

—

Countries

Germany

Contacts

Public ContactCaroline Rometsch

Abteilung für Psychosomatische Medizin und Psychotherapie

Caroline.Rometsch@med.ogvu.de+49391671200

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026