Auricular Acupuncture for Treatment of Preoperative Anxiety

University Medicine Greifswald42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anxiety

Interventions

Five ear acupuncture points: MA-IC, MA-TF1, MA-SC, MA-AT1 and MA-TG will be needled bilaterally in patients, who will wish to receive AA. Indwelling fixed "New Pyonex" needles (length: 1.5 mm, diameter: 0.22 mm; Seirin Corp., Shizuoka City, Japan) will be used for AA.

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Situational anxiety_1

State (situational) anxiety will be measured using State-Trait-Anxiety Inventory (STAI).

Time frame: Situational anxiety_1 will be measured on the day before surgery before auricular acupuncture

Situational anxiety_2

State (situational) anxiety will be measured using State-Trait-Anxiety Inventory

Time frame: Situational anxiety_2 will be measured and in the evening of the day before surgery

Situational anxiety_3

State (situational) anxiety will be measured using State-Trait-Anxiety Inventory

Time frame: Situational anxiety_3 will be measured on the day of surgery immediately before the operation

Secondary Outcomes

Heart rate

Time frame: On the day of surgery before the surgery

Blood pressure