Auricular Acupuncture for Treatment of Preoperative Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-05-31

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.

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Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Auricular acupuncture + standard therapy

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

Group Type ACTIVE_COMPARATOR

Auricular acupuncture

Intervention Type DEVICE

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.

Standard therapy alone

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Auricular acupuncture

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No