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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
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

19 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

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

First Posted
January 12, 2016
Last Updated
June 27, 2016
Sponsor
University Medicine Greifswald
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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

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Auricular Acupuncture for Treatment of Preoperative Anxiety

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