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Auricular Acupuncture for Treatment of Preoperative Anxiety (AcuAnx)

U

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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