Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
Conditions
Keywords
Transcranial Alternating Current Stimulation, Postoperative Anxiety, Intraspinal Tumor Resection, Postoperative Recovery
Brief summary
The incidence of postoperative anxiety in surgery ranges from 4.1% to 79.6% , and among patients undergoing intraspinal tumor resection surgery, the incidence of postoperative anxiety is as high as 46.7%.Adverse effects induced by anxiety include insomnia, exacerbated pain, impaired wound healing and immune function, increased risk of adverse cardiovascular events, and postoperative cognitive dysfunction. These may lead to postoperative depression and chronic pain, significantly delaying patient recovery. The goal of this study is to investigate the effects of intraoperative transcranial alternating current stimulation on postoperative anxiety in adult patients undergoing intraspinal tumor resection. It will also evaluate the safety of the transcranial alternating current stimulation. This study will enroll adult patients undergoing elective intraspinal tumor resection surgery. The study will compare the transcranial alternating current stimulation with a sham stimulation to see whether the intervention can reduce the incidence of postoperative anxiety. The trial will also compare the anxiety scores, the incidence of delirium, pain scores, frial scores, sleep quality scores, recovery quality scores and adverse events between intervention and control groups. We also plan to compare the electroencephalography parameters and serum level of substance P to investigate the potential mechanism.
Interventions
DEVICETranscranial Alternating Current Stimulation
This study uses intraoperative transcranial alternating current stimulation (tACS) delivered via a non-invasive, portable electrical stimulation device. The intervention consists of 10 Hz alternating current at 2 mA intensity, applied bilaterally over the prefrontal cortex (F3/F4 electrode positions) for 20 minutes immediately following anesthesia induction during elective intraspinal tumor resection. The device is calibrated to deliver a consistent, low-level current that does not interfere with standard anesthesia or surgical procedures.
DEVICESham (No Treatment)
Wear the transcranial electrical stimulator without applying electric current
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 65 years old * Scheduled for elective intraspinal tumor resection under general anesthesia * American Society of Anesthesiologists physical status I-III * Able to understand and complete the Hospital Anxiety and Depression Scale and other study-related questionnaires * Voluntarily sign the informed consent form * Right handed
Exclusion criteria
* Preoperative HADS-A score ≥ 8 * History of psychiatric disorders (e.g., depression, psychosis) or use of psychotropic medications within the past 3 months * History of neurological diseases (e.g., epilepsy, stroke, dementia) or severe head trauma * Contraindications to transcranial alternating current stimulation, including metallic implants in the head, skull defects, or a history of seizures * Severe visual or auditory impairment that affects communication * severe cardiovascular and cerebral vascular diseases * Participation in other clinical trials within the past 30 days * A Mini-Mental State Examination (MMSE) score \< 15
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Anxiety Within 3 Days After Surgery | From the day of surgery up to postoperative day 3 | The primary outcome is the incidence of postoperative anxiety, defined as a Hospital Anxiety and Depression Scale-Anxiety score ≥ 8 at any time point on the day of surgery or postoperative days 1, 2, or 3. Participants will be assessed by trained evaluators blinded to group allocation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of postoperative anxiety | 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery | Anxiety severity will be evaluated using the Hospital Anxiety and Depression Scale-Anxiety score. Assessments will be performed at 1 day before surgery, the day of surgery, postoperative days 1, 2, 3, and 3 months after surgery. |
| Postoperative delirium assessed by 3-minute Diagnostic Confusion Assessment Method score | In the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3 | Postoperative delirium will be evaluated using the 3-minute Diagnostic Confusion Assessment Method score. Assessments will be performed in the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3. |
| Postoperative pain intensity assessed by Numeric Rating Scale score | 1 day before surgery, 6, 24, 48, and 72 hours after surgery | Postoperative pain intensity will be evaluated using the Numeric Rating Scale score at 1 day before surgery and at 6, 24, 48, and 72 hours after surgery. |
| Frailty status assessed by Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score | 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery | Frailty will be evaluated using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score at 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery. |
| Sleep quality assessed by Pittsburgh Sleep Quality Index score | 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery | Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index score at 1 day before surgery, the day of surgery, postoperative days 1, 2, 3, and 3 months after surgery. |
| Quality of recovery assessed by 15-item Quality of Recovery score | Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery | Postoperative recovery quality will be evaluated using the 15-item Quality of Recovery score on the day of surgery, postoperative days 1, 2, 3, and 1 month after surgery. |
| Time to ambulation | Day of surgery, postoperative days 1, 2, 3 | Time to first ambulation after surgery will be recorded and compared between groups. |
| Length of hospital stay | From the day when patient hospitalization to 3 weeks after surgery | Total length of hospital stay will be recorded and compared between groups. |
| Incidence of adverse events, complications, and 30-day all-cause mortality | Up to 30 days after surgery | Incidence of adverse events, complications, and 30-day all-cause mortality will be monitored and compared between groups. |
Countries
China
Contacts
CONTACTwei Xiao
Outcome results
None listed