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Effects of percutaneous auricular vagus nerve stimulation on preoperative anxiety in patients with uterine leiomyoma laparoscopy

Effects of percutaneous auricular vagus nerve stimulation on preoperative anxiety in patients with uterine leiomyoma laparoscopy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092521
Enrollment
Unknown
Registered
2024-11-18
Start date
2024-11-18
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Group T :Percutaneous ear vagus nerve stimulation
Group F:Fake stimulus

Sponsors

The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with a score of more than 20 on the state anxiety scale who were scheduled for HYSTEROMYOMA laparoscopy and general anesthesia with tracheal intubation had preoperative American Society of Anesthesiologists Grade i-II, and were aged 18-65 years without menopause, those with education level of primary school or above, BMI 18.5 ~ 24.0 kg/m ~ 2, agreed to participate in the study and signed the informed consent.

Exclusion criteria

Exclusion criteria: Patients who have experienced the use of an ear vagus stimulator or a skin injury to the left ear concha, and those who have an implantable electronic device such as an implantable vagus stimulator, a artificial pacemaker or an automatic implantable cardiac defibrillator, patients with fear of electrical stimulation, airway hyperresponsiveness (asthma, chronic obstructive pulmonary disease, long-term smoking history) , sinus bradycardia (heart rate less than 50 beats per minute) or sinus node lesion before operation, second-degree or third-degree AV block, central nervous system or mental illness (e.g. , anxiety, depression, etc.) , long-term use of narcotic analgesia, sedation, non-steroidal anti-inflammatory drug or sleeping medication, those who have hearing and language barrier, can not communicate with doctors effectively, can not understand or refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
The difference of State Anxiety Inventory (SAI) scores before intervention (T0) and after intervention (T1);Hospital Anxiety and Depression Scale;Athens Insomnia Scale;Mean arterial pressure;Heart rate;Pulse oxygen saturation;Trait Anxiety Inventory;

Secondary

MeasureTime frame
Amsterdam Preoperative Anxiety and Information Scale;

Countries

China

Contacts

Public ContactZheng Ying

The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University(Huai'an First People's Hospital)

1794994673@qq.com+86 137 7670 9827

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026