Depression
Conditions
Interventions
taVNS group:Percutaneous auricular vagus nerve stimulation (taVNS), using the instrument model tVN501, with a frequency of 20Hz, a pulse width of 500µs, and a current intensity of 4-6mA, lasts for 30
Control group:False stimulation involves only a 30-second phase of current increase and a 30-second phase of current decrease during each treatment, without continuous stimulation
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65; 2. ASA Grade I-III; 3. Mild to severe depressive symptoms (11 points < MADRS < 35 points); 4. Female patients scheduled for unilateral radical mastectomy under general anesthesia; 5. Aware of, agreeing to participate in the trial and signing the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. There were severe disorders of heart, lung, liver and kidney functions before the operation; 2. Preoperative radiotherapy or endocrine therapy patients and those undergoing secondary surgery (recurrence or reconstruction); 3. There is a history of mental illness, bipolar disorder or recurrent depression before the operation; 4. Screen for a history of antidepressant treatment or long-term use of psychotropic drugs, long-term use of analgesic drugs, or alcohol abuse within 2 weeks prior to the screening; 5. Inability to cooperate with the researcher for any reason: such as hearing or vision impairment, language comprehension disorder, mental illness, etc; 6. Electronic devices cannot be implanted; 7. Pregnant or lactating women; 8. Participated in other clinical studies in the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with postoperative depression achieving response (=50% reduction in MADRS score from baseline); | — |
Secondary
| Measure | Time frame |
|---|---|
| MADRS Score;Proportion of patients with postoperative depression achieving remission (MADRS score =11);GAD-7 Score;PSQI Score;QoR-15 Score;Postoperative NRS Pain Score;Length of Stay (LOS); | — |
Countries
China
Contacts
Public ContactChen Lijian
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed