Auricular Acupuncture for Treatment of Preoperative Anxiety

Phase 2

Completed

• Conditions: Anxiety
• Interventions: Device: Auricular acupuncture

• Registration Number: NCT02656966
• Lead Sponsor: University Medicine Greifswald

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auricular acupuncture + standard therapy	Auricular acupuncture	Patients, who will wish acupuncture, will receive this intervention, in addition to standard therapy

Primary Outcome Measures

Name	Time	Method
Situational anxiety_3	Situational anxiety_3 will be measured on the day of surgery immediately before the operation	State (situational) anxiety will be measured using State-Trait-Anxiety Inventory
Situational anxiety_1	Situational anxiety_1 will be measured on the day before surgery before auricular acupuncture	State (situational) anxiety will be measured using State-Trait-Anxiety Inventory (STAI).
Situational anxiety_2	Situational anxiety_2 will be measured and in the evening of the day before surgery	State (situational) anxiety will be measured using State-Trait-Anxiety Inventory

Secondary Outcome Measures

Name	Time	Method
Blood pressure	On the day of surgery before the surgery
Heart rate	On the day of surgery before the surgery

Trial Locations

Locations (1)

University Medicine of Greifswald; 🇩🇪 Greifswald, Germany