Perioperative AnxietytaVNS-MASAnxNCT07495163
Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery
A study testing transauricular auricular vagus nerve stimulation in people with Perioperative Anxiety and Major Abdominal Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites in China.
Trial summary
It is reported that over 50% of patients undergoing major abdominal surgery experience perioperative anxiety, which often triggers a vicious cycle of "anxiety-pain-gastrointestinal dysfunction" and significantly hinders postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Perioperative Anxiety, Major Abdominal Surgery
- What is being tested?
- transauricular auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 4 sitesChina
- Study dates
- 1 May 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Between 18 and 85 years.
- Patients undergoing elective major abdominal surgery under general anesthesia, with an anticipated operative duration of ≥ 2 hours and a predicted postoperative length of stay of ≥ 2 days.
- ASA classification I-III.
Who cannot join
- Active skin breakdown, erythema, swelling, infection of the ear, or significant anatomical abnormalities of the external ear.
- Pre-existing bradycardia (resting heart rate < 50 beats/min) or third-degree atrioventricular block.
- Presence of a cardiac pacemaker or other active electronic implants.
- A documented history of traumatic brain injury within the past 6 months.
- Chronic pain or long-term reliance on analgesic medications.
- Severe neuropsychiatric disorders or chronic use of psychotropic medications, including corticosteroids, antidepressants, or anxiolytics.
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- Severe cognitive impairment or any condition precluding effective communication or completion of the assessment scales.
- Women who were pregnant, lactating, or planning to conceive.
- Current enrollment in other interventional clinical trials.
- Anticipated direct transfer to the ICU immediately following surgery.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Hangzhou
Lina Yu, +86-13958033387, zryulina@zju.edu.cn
Huzhou Central Hospital
Huzhou, Zhejiang
The Second Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang
Hongmei Zhou, +86-13867300139, drhongmeizhou@163.com
Jiande First People's Hospital
Meicheng, Zhejiang
Sanyue Wang, +86-13968126731, 1501556348@qq.com
About this study
Official title: Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Anxiety in Patients Undergoing Major Abdominal Surgery
It is reported that over 50% of patients undergoing major abdominal surgery experience perioperative anxiety, which often triggers a vicious cycle of "anxiety-pain-gastrointestinal dysfunction" and significantly hinders postoperative recovery. Existing pharmacological and psychological interventions are limited by adverse effects such as respiratory depression, paralytic ileus, and poor patient compliance. While transcutaneous auricular vagus nerve stimulation (taVNS) has shown promise as a non-invasive neuromodulation technique for chronic neuropsychiatric disorders, high-quality evidence regarding its application in anxiety-susceptible perioperative populations is still lacking. This multicenter, randomized, parallel-group, double-blind, sham-controlled trial aims to recruit 282 patients undergoing elective major abdominal surgery across four centers in Mainland China. Eligible participants will be randomized (1:1) to receive either taVNS or sham stimulation for 60 minutes daily from two days prior to surgery through the day of the operation. The primary outcome is the incidence of perioperative anxiety from the day of surgery to 72 hours postoperatively, while secondary outcomes include depression, sleep quality, pain intensity, postoperative delirium, frailty scores, quality of recovery, time to first flatus and defecation, and length of hospital stay.
- Conditions
- Perioperative Anxiety, Major Abdominal Surgery
- Being tested
- transauricular auricular vagus nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transauricular auricular vagus nerve stimulationDevice
Patients will receive three taVNS sessions, with each session lasting 60 minutes.
transauricular auricular vagus nerve stimulationDevice
Patients will receive three sham taVNS sessions, with each session lasting 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| taVNS group | Active comparator | Participants in the taVNS group will receive 60-minute stimulation sessions daily, starting from two days preoperatively and continuing through the day of surgery, for a total of three sessions. Receives: Device: transauricular auricular vagus nerve stimulation |
| sham group | Sham comparator | Participants in the sham group will receive 60-minute sham stimulation sessions daily, starting from two days preoperatively and continuing through the day of surgery, for a total of three sessions. Receives: Device: transauricular auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perioperative anxiety
Incidence of perioperative anxiety from the day of surgery through 72 hours postoperatively, as assessed by the 14-item Hamilton Anxiety Rating Scale (HAMA-14).
Measured: From the day of surgery through 72 hours postoperatively following the completion of the intervention
Secondary outcomes (10)
Severity and scores of perioperative anxiety
Perioperative anxiety severity and scores will be evaluated at the following timepoints: pre- and post-intervention (T0-T5); 2 hours post-surgery (T6); postoperative days 1, 2, 3, and 7 (T7-T10); and one month post-surgery (T11)
Measured: Within one month postoperatively
Severity and scores of perioperative depression
Severity and scores of perioperative depression (HAMD-24) will be evaluated at the following timepoints: pre- and post-intervention (T0-T5); 2 hours post-surgery (T6); postoperative days 1, 2, 3, and 7 (T7-T10); and one month post-surgery (T11)
Measured: Within one month postoperatively
Sleep Quality
Sleep Quality (Pittsburgh Sleep Quality Index [PSQI]) will be evaluated at the following timepoints: postoperative days 1, 3, and 7 (T7, T9, T10), and at the one-month postoperative follow-up (T11)
Measured: Within one month postoperatively
Pain intensity
Pain Intensity (Numeric Rating Scale[NRS]) will be assessed at the following timepoints: 2 hours post-surgery (T6); postoperative days 1, 2, 3, and 7 (T7-T10); and at the one-month postoperative follow-up (T11)
Measured: Within one month postoperatively
Incidence of postoperative delirium within the first 7 days after surgery
Incidence and severity of postoperative delirium (CAM-3D) will be evaluated at the following timepoints: 2 hours post-surgery (T6) and postoperative days 1, 2, 3, and 7 (T7-T10)
Measured: Within 7 days postoperatively
Frailty score
Frailty Score (The FRAIL Scale [Fatigue, Resistance, Ambulation, Illness, and Loss of Weight]) will be evaluated at the following timepoints: postoperative days 1, 3, and 7 (T7, T9, T10), and at the one-month postoperative follow-up (T11). The FRAIL scale assesses five components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight
Measured: Within one month postoperatively
Quality of recovery
Quality of Recovery (Quality of Recovery Scale[QoR-15]) will be evaluated at the following timepoints: postoperative days 1, 3, and 7 (T7, T9, T10), and at the one-month postoperative follow-up (T11)
Measured: Within one month postoperatively
Opioid consumption within the first 7 postoperative days
Opioid consumption within the first 7 postoperative days
Measured: Within 7 days postoperatively
Postoperative recovery: including time to first ambulation, time to first flatus, and time to first defecation
Postoperative recovery milestones: including time to first ambulation, time to first flatus, and time to first defecation
Measured: up to 1 month
Length of hospital stay
Length of hospital stay
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative AnxietyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yu lina, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495163
- Sponsor's protocol ID
- 2026-0369
- Acronym
- taVNS-MASAnx
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Anxiety in Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07495163
- Acronym / sponsor ID
- taVNS-MASAnx / 2026-0369
- Conditions
- Perioperative Anxiety, Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is reported that over 50% of patients undergoing major abdominal surgery experience perioperative anxiety, which often triggers a vicious cycle of "anxiety-pain-gastrointestinal dysfunction" and significantly hinders postoperative recovery. Existing pharmacological and psychological interventions are limited by adverse effects such as respiratory depression, paralytic ileus, and poor patient compliance. While transcutaneous auricular vagus nerve stimulation (taVNS) has shown promise as a non-invasive neuromodulation technique for chronic neuropsychiatric disorders, high-quality evidence regarding its application in anxiety-susceptible perioperative populations is still lacking. This multicenter, randomized, parallel-group, double-blind, sham-controlled trial aims to recruit 282 patients undergoing elective major abdominal surgery across four centers in Mainland China. Eligible participants will be randomized (1:1) to receive either taVNS or sham stimulation for 60 minutes daily from two days prior to surgery through the day of the operation. The primary outcome is the incidence of perioperative anxiety from the day of surgery to 72 hours postoperatively, while secondary outcomes include depression, sleep quality, pain intensity, postoperative delirium, frailty scores, quality of recovery, time to first flatus and defecation, and length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS group | Active comparator | Device: transauricular auricular vagus nerve stimulationParticipants in the taVNS group will receive 60-minute stimulation sessions daily, starting from two days preoperatively and continuing through the day of surgery, for a total of three sessions. |
| sham group | Sham comparator | Device: transauricular auricular vagus nerve stimulationParticipants in the sham group will receive 60-minute sham stimulation sessions daily, starting from two days preoperatively and continuing through the day of surgery, for a total of three sessions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: Between 18 and 85 years.
- Patients undergoing elective major abdominal surgery under general anesthesia, with an anticipated operative duration of ≥ 2 hours and a predicted postoperative length of stay of ≥ 2 days.
- ASA classification I-III.
Key exclusion criteria (10 listed)
- Active skin breakdown, erythema, swelling, infection of the ear, or significant anatomical abnormalities of the external ear.
- Pre-existing bradycardia (resting heart rate < 50 beats/min) or third-degree atrioventricular block.
- Presence of a cardiac pacemaker or other active electronic implants.
- A documented history of traumatic brain injury within the past 6 months.
- Chronic pain or long-term reliance on analgesic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transauricular auricular vagus nerve stimulationPatients will receive three taVNS sessions, with each session lasting 60 minutes. | Device | taVNS group |
| transauricular auricular vagus nerve stimulationPatients will receive three sham taVNS sessions, with each session lasting 60 minutes. | Device | sham group |
Primary outcome
Incidence of perioperative anxiety
Time frame: From the day of surgery through 72 hours postoperatively following the completion of the intervention
Incidence of perioperative anxiety from the day of surgery through 72 hours postoperatively, as assessed by the 14-item Hamilton Anxiety Rating Scale (HAMA-14).
10 secondary outcomes
Severity and scores of perioperative anxiety
Time frame: Within one month postoperatively
Severity and scores of perioperative depression
Time frame: Within one month postoperatively
Sleep Quality
Time frame: Within one month postoperatively
Pain intensity
Time frame: Within one month postoperatively
Incidence of postoperative delirium within the first 7 days after surgery
Time frame: Within 7 days postoperatively
Frailty score
Time frame: Within one month postoperatively
Quality of recovery
Time frame: Within one month postoperatively
Opioid consumption within the first 7 postoperative days
Time frame: Within 7 days postoperatively
Postoperative recovery: including time to first ambulation, time to first flatus, and time to first defecation
Time frame: up to 1 month
Length of hospital stay
Time frame: up to 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transauricular auricular vagus nerve stimulation in people with Perioperative Anxiety and Major Abdominal Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Yu, M.D. (8613958033387, zryulina@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perioperative anxiety (time frame: From the day of surgery through 72 hours postoperatively following the completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.