Auricular Acupuncture for Treatment of Preoperative Anxiety

Study Overview
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Brief Summary
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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.

Official Title
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Auricular Acupuncture vs. Standard Therapy for Treatment of Preoperative Anxiety in Patients Scheduled for Ambulatory Gynaecological Surgery - a Pilot Non-randomized Controlled Trial

Conditions
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Anxiety

Intervention / Treatment
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* Device: Auricular acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an American Society of Anaesthesiologists physical status of I to II scheduled for elective ambulatory gynaecological surgery under standardized general anaesthesia Surgery time does not exceed 60 minutes Patients without previous opioid and psychotropic medication Patients aged between 19 and 55 years, able to fill in the STAI questionnaire Patients who have given written informed consent Exclusion Criteria: Current psychiatric disease Local skin infection at the sites of acupuncture Aged < 19 or > 55 years Failure to follow the standardized schema of general anaesthesia Surgery time more than 60 minutes Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines) Patients who consumed opioid medication at least 6 months before surgery Patients who are unable to understand the consent form or to fill in the STAI questionnaire

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Auricular acupuncture + standard therapy<br>Patients, who will wish acupuncture, will receive this intervention, in addition to standard therapy | Device: Auricular acupuncture<br>* 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.<br>|
| No Intervention: Standard therapy alone<br>Patients who do not wish acupuncture will be asked if they will fill in the study questionnaire | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Situational anxiety_1 | State (situational) anxiety will be measured using State-Trait-Anxiety Inventory (STAI). | 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 | 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 | Situational anxiety_3 will be measured on the day of surgery immediately before the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | On the day of surgery before the surgery | 
| Blood pressure |  | On the day of surgery before the surgery |