NCT02656966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 anxiety

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_2 anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

January 12, 2016

Last Update Submit

June 27, 2016

Conditions

Anxiety

Outcome Measures

Primary Outcomes (3)

  • Situational anxiety_1

    State (situational) anxiety will be measured using State-Trait-Anxiety Inventory (STAI).

    Situational anxiety_1 will be measured on the day before surgery before auricular acupuncture

  • Situational anxiety_2

    State (situational) anxiety will be measured using State-Trait-Anxiety Inventory

    Situational anxiety_2 will be measured and in the evening of the day before surgery

  • Situational anxiety_3

    State (situational) anxiety will be measured using State-Trait-Anxiety Inventory

    Situational anxiety_3 will be measured on the day of surgery immediately before the operation

Secondary Outcomes (2)

  • Heart rate

    On the day of surgery before the surgery

  • Blood pressure

    On the day of surgery before the surgery

Study Arms (2)

Auricular acupuncture + standard therapy

ACTIVE COMPARATOR

Patients, who will wish acupuncture, will receive this intervention, in addition to standard therapy

Device: Auricular acupuncture

Standard therapy alone

NO INTERVENTION

Patients who do not wish acupuncture will be asked if they will fill in the study questionnaire

Interventions

Auricular acupunctureDEVICE

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.

Auricular acupuncture + standard therapy

Eligibility Criteria

Age19 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine of Greifswald

Greifswald, 17475, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29986900DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 15, 2016

Study Start

December 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

DE(1)