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NCT Number: NCT02656966

Auricular Acupuncture for Treatment of Preoperative Anxiety

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

19 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Medicine of Greifswald

Greifswald, 17475, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular Acupuncture

Device

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 outcomes

  1. 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).

  2. 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

  3. 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

Secondary outcomes

  1. Heart rate

    Time frame: On the day of surgery before the surgery

  2. Blood pressure

    Time frame: On the day of surgery before the surgery

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

Auricular Acupuncture vs. Standard Therapy for Treatment of Preoperative Anxiety in Patients Scheduled for Ambulatory Gynaecological Surgery - a Pilot Non-randomized Controlled Trial

Acronym: AcuAnx

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2016
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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