Auricular Acupuncture for Treatment of Preoperative Anxiety (AcuAnx)
Primary Purpose
Anxiety
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Auricular acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Patients with an American Society of Anaesthesiologists physical status of I to II scheduled for elective ambulatory gynaecological surgery under standardized general anaesthesia
- Surgery time does not exceed 60 minutes
- Patients without previous opioid and psychotropic medication
- Patients aged between 19 and 55 years, able to fill in the STAI questionnaire
- Patients who have given written informed consent
Exclusion Criteria:
- Current psychiatric disease
- Local skin infection at the sites of acupuncture
- Aged < 19 or > 55 years
- Failure to follow the standardized schema of general anaesthesia
- Surgery time more than 60 minutes
- Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
- Patients who consumed opioid medication at least 6 months before surgery
- Patients who are unable to understand the consent form or to fill in the STAI questionnaire
Sites / Locations
- University Medicine of Greifswald
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Auricular acupuncture + standard therapy
Standard therapy alone
Arm Description
Patients, who will wish acupuncture, will receive this intervention, in addition to standard therapy
Patients who do not wish acupuncture will be asked if they will fill in the study questionnaire
Outcomes
Primary Outcome Measures
Situational anxiety_1
State (situational) anxiety will be measured using State-Trait-Anxiety Inventory (STAI).
Situational anxiety_2
State (situational) anxiety will be measured using State-Trait-Anxiety Inventory
Situational anxiety_3
State (situational) anxiety will be measured using State-Trait-Anxiety Inventory
Secondary Outcome Measures
Heart rate
Blood pressure
Full Information
NCT ID
NCT02656966
First Posted
January 12, 2016
Last Updated
June 27, 2016
Sponsor
University Medicine Greifswald
1. Study Identification
Unique Protocol Identification Number
NCT02656966
Brief Title
Auricular Acupuncture for Treatment of Preoperative Anxiety
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular acupuncture + standard therapy
Arm Type
Active Comparator
Arm Description
Patients, who will wish acupuncture, will receive this intervention, in addition to standard therapy
Arm Title
Standard therapy alone
Arm Type
No Intervention
Arm Description
Patients who do not wish acupuncture will be asked if they will fill in the study questionnaire
Intervention Type
Device
Intervention Name(s)
Auricular acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Situational anxiety_1
Description
State (situational) anxiety will be measured using State-Trait-Anxiety Inventory (STAI).
Time Frame
Situational anxiety_1 will be measured on the day before surgery before auricular acupuncture
Title
Situational anxiety_2
Description
State (situational) anxiety will be measured using State-Trait-Anxiety Inventory
Time Frame
Situational anxiety_2 will be measured and in the evening of the day before surgery
Title
Situational anxiety_3
Description
State (situational) anxiety will be measured using State-Trait-Anxiety Inventory
Time Frame
Situational anxiety_3 will be measured on the day of surgery immediately before the operation
Secondary Outcome Measure Information:
Title
Heart rate
Time Frame
On the day of surgery before the surgery
Title
Blood pressure
Time Frame
On the day of surgery before the surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with an American Society of Anaesthesiologists physical status of I to II scheduled for elective ambulatory gynaecological surgery under standardized general anaesthesia
Surgery time does not exceed 60 minutes
Patients without previous opioid and psychotropic medication
Patients aged between 19 and 55 years, able to fill in the STAI questionnaire
Patients who have given written informed consent
Exclusion Criteria:
Current psychiatric disease
Local skin infection at the sites of acupuncture
Aged < 19 or > 55 years
Failure to follow the standardized schema of general anaesthesia
Surgery time more than 60 minutes
Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
Patients who consumed opioid medication at least 6 months before surgery
Patients who are unable to understand the consent form or to fill in the STAI questionnaire
Facility Information:
Facility Name
University Medicine of Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29986900
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.
Results Reference
derived
Learn more about this trial
Auricular Acupuncture for Treatment of Preoperative Anxiety
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