Auricular Acupuncture for Treatment of Preoperative Anxiety (AcuAnx)

University Medicine Greifswald

Status and phase: Completed; Phase 2

Conditions: Anxiety

Treatments: Device: Auricular acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02656966

BB 158/15

Details and patient eligibility

About

In this prospective nonrandomized study the investigators are going to investigate whether auricular acupuncture with indwelling fixed needles is feasible for treatment of preoperative anxiety.

Patients, scheduled for ambulatory gynecologic surgery, will be asked, if they wish to receive auricular acupuncture (AA) against preoperative anxiety. The patients who will not wish AA, will be asked to take part in questioning (State-Trait-Anxiety-Inventory (STAI) questionnaire) and will form the control group. The preoperative anxiety using STAI, as well as the duration and quality of sleep on the night before surgery, the incidence of side effects, blood pressure and heart rate will be the outcome measures in this study.

Enrollment: 42 patients

Sex: Female

Ages: 19 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with an American Society of Anaesthesiologists physical status of I to II scheduled for elective ambulatory gynaecological surgery under standardized general anaesthesia
2. Surgery time does not exceed 60 minutes
3. Patients without previous opioid and psychotropic medication
4. Patients aged between 19 and 55 years, able to fill in the STAI questionnaire
5. Patients who have given written informed consent

Exclusion criteria

1. Current psychiatric disease
2. Local skin infection at the sites of acupuncture
3. Aged < 19 or > 55 years
4. Failure to follow the standardized schema of general anaesthesia
5. Surgery time more than 60 minutes
6. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
7. Patients who consumed opioid medication at least 6 months before surgery
8. Patients who are unable to understand the consent form or to fill in the STAI questionnaire

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 2 patient groups

Auricular acupuncture + standard therapy

Active Comparator group

Description:

Patients, who will wish acupuncture, will receive this intervention, in addition to standard therapy

Treatment:

Device: Auricular acupuncture

Standard therapy alone

No Intervention group

Description:

Patients who do not wish acupuncture will be asked if they will fill in the study questionnaire