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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
232
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.
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.
Beijing Tiantan Hospital
Beijing, China
First Medical Center of Chinese PLA General Hospital, Beijing, China.
Beijing, China
Incidence of Postoperative Depressive Symptoms
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.
Time frame: Within 3 days after surgery
Incidence of Postoperative Anxiety Symptoms
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).
Time frame: Within 3 days, 7 days, and at 30 days after surgery
Incidence of Depressive Symptoms
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.
Time frame: Postoperative day 7 and 30
Postoperative Nausea and Vomiting (PONV)
Assessed using a Visual Analogue Scale (VAS, 0-10)
Time frame: Within 3 days after surgery
Postoperative Pain Score
Assessed using the Numerical Rating Scale (NRS, 0-10).
Time frame: Postoperative day 3, 7, and 30
Postoperative Sleep Quality
Assessed using the Insomnia Severity Index (ISI, score 0-28).
Time frame: Postoperative day 3, 7, and 30
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Time to First Postoperative Flatus and Defecation
Time to First Postoperative Flatus and Defecation
Time frame: From end of surgery until first occurrence, assessed up to 7 days
Postoperative Recovery Quality
Assessed using the Quality of Recovery-15 or QoR-40 scale.
Time frame: Postoperative day 3, 7, and 30
Postoperative Quality of Life
Assessed using the EQ-5D-5L scale.
Time frame: Postoperative day 3, 7, and 30