Auricular Acupuncture for Treatment of Preoperative Anxiety (AcuAnx)
|ClinicalTrials.gov Identifier: NCT02656966|
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : June 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety||Device: Auricular acupuncture||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Active Comparator: Auricular acupuncture + standard therapy
Patients, who will wish acupuncture, will receive this intervention, in addition to standard therapy
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.
No Intervention: Standard therapy alone
Patients who do not wish acupuncture will be asked if they will fill in the study questionnaire
- Situational anxiety_1 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- Heart rate [ Time Frame: On the day of surgery before the surgery ]
- Blood pressure [ Time Frame: On the day of surgery before the surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656966
|University Medicine of Greifswald|
|Greifswald, Germany, 17475|