Anxiety
Conditions
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.
Interventions
DEVICEAuricular 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.
Sponsors
University Medicine Greifswald
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate | On the day of surgery before the surgery |
| Blood pressure | On the day of surgery before the surgery |
Countries
Germany
Outcome results
None listed