Clinical trial NCT02656966: Auricular Acupuncture for Treatment of Preoperative Anxiety
Official title: Auricular Acupuncture vs. Standard Therapy for Treatment of Preoperative Anxiety in Patients Scheduled for Ambulatory Gynaecological Surgery - a Pilot Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 42
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Situational anxiety_1
timeFrame: Situational anxiety_1 will be measured on the day before surgery before auricular acupuncture
measure: Situational anxiety_2
timeFrame: Situational anxiety_2 will be measured and in the evening of the day before surgery
measure: Situational anxiety_3
timeFrame: Situational anxiety_3 will be measured on the day of surgery immediately before the operation
Secondary outcomes:
measure: Heart rate
timeFrame: On the day of surgery before the surgery
measure: Blood pressure
timeFrame: On the day of surgery before the surgery
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine of Greifswald
Study officials:
References:
citation: Wunsch JK, Klausenitz C, Janner H, Hesse T, Mustea A, Hahnenkamp K, Petersmann A, Usichenko TI. Auricular acupuncture for treatment of preoperative anxiety in patients scheduled for ambulatory gynaecological surgery: a prospective controlled investigation with a non-randomised arm. Acupunct Med. 2018 Aug;36(4):222-227. doi: 10.1136/acupmed-2017-011456. Epub 2018 Jul 9.