Depression, Postoperative, Anxiety, Breast Surgery
Conditions
Keywords
Transcutaneous Vagus Nerve Stimulation, Breast Cancer Surgery, Depression, Anxiety, Randomized Controlled Trial
Brief summary
A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of a single session of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on perioperative negative emotions (anxiety and depression), pain, nausea, sleep, and recovery in patients undergoing elective breast cancer surgery.
Detailed description
Patients undergoing breast cancer surgery frequently experience perioperative anxiety and depression, which can adversely affect recovery and quality of life. This study evaluates the efficacy of a single 30-minute intraoperative taVNS session in mitigating these negative emotions and improving postoperative outcomes. Patients will be randomized to receive either active taVNS or sham stimulation after anesthesia induction. The primary outcome is the incidence of depressive symptoms within 3 days postoperatively. Secondary outcomes include anxiety, pain, PONV, sleep quality, and recovery parameters.
Interventions
DEVICEActive taVNS
Stimulation parameters: Amplitude 20 (mA), Frequency 20Hz, Pulse width 200μs, asymmetric biphasic square wave. A single 30-minute stimulation session is applied to the left auricular concha after anesthesia induction.
DEVICESham taVNS
The sham device is identical in appearance, weight, indicator lights, and operation sounds to the active device but delivers no effective electrical current. It is applied to the left auricular concha for 30 minutes after anesthesia induction.
Sponsors
Chinese PLA General Hospital
Beijing Tiantan Hospital
Peking University Shougang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years. Scheduled for elective breast cancer surgery. ASA physical status I-III. Willing and able to provide informed consent.
Exclusion criteria
* Preoperative MMSE score \< 24; severe communication barriers. History of diagnosed dementia, Parkinson's disease, schizophrenia, bipolar disorder, major depressive disorder, or long-term use of psychotropic drugs. Skin lesions, infection, or deformity of bilateral ears; history of ear surgery or nerve injury; allergy to electrode materials. Severe arrhythmia; implanted electronic devices (e.g., pacemaker, ICD). Participation in another interventional trial within 3 months. Other conditions deemed unsuitable by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Depressive Symptoms | Within 3 days after surgery | Assessed using the Patient Health Questionnaire-9 (PHQ-9), Hamilton Depression Rating Scale (HAMD-17), and the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). A score above the standard cut-off on any of these scales indicates the presence of depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Anxiety Symptoms | Within 3 days, 7 days, and at 30 days after surgery | Assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), the Generalized Anxiety Disorder-7 (GAD-7), and the Self-Rating Anxiety Scale (SAS). |
| Incidence of Depressive Symptoms | Postoperative day 7 and 30 | Assessed using the Patient Health Questionnaire-9 (PHQ-9), Hamilton Depression Rating Scale (HAMD-17), and the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). A score above the standard cut-off on any of these scales indicates the presence of depressive symptoms.Higher scores indicate greater severity of depression. |
| Postoperative Nausea and Vomiting (PONV) | Within 3 days after surgery | Assessed using a Visual Analogue Scale (VAS, 0-10) |
| Postoperative Pain Score | Postoperative day 3, 7, and 30 | Assessed using the Numerical Rating Scale (NRS, 0-10). |
| Time to First Postoperative Flatus and Defecation | From end of surgery until first occurrence, assessed up to 7 days | Time to First Postoperative Flatus and Defecation |
| Postoperative Recovery Quality | Postoperative day 3, 7, and 30 | Assessed using the Quality of Recovery-15 or QoR-40 scale. |
| Postoperative Sleep Quality | Postoperative day 3, 7, and 30 | Assessed using the Insomnia Severity Index (ISI, score 0-28). |
| Postoperative Quality of Life | Postoperative day 3, 7, and 30 | Assessed using the EQ-5D-5L scale. |
Countries
China
Contacts
CONTACTWeidong Mi
Outcome results
None listed