Auricular Acupuncture for Treatment of Preoperative Anxiety

Anxiety Clinical Trial

— AcuAnx  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656966
• Other study ID #: BB 158/15
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2016
• Last updated: June 27, 2016
• Start date: December 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	University Medicine of Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Heart rate		On the day of surgery before the surgery	Yes
Secondary	Blood pressure		On the day of surgery before the surgery	Yes