AnxietyPhase 2AcuAnxNCT02656966
Auricular Acupuncture for Treatment of Preoperative Anxiety
A Phase 2 study testing Auricular acupuncture in people with Anxiety, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, women only
- Conditions the study is for
- Anxiety
- What is being tested?
- Auricular acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Anxiety
- Being tested
- Auricular acupuncture
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Auricular acupuncture + standard therapy | Active comparator | Patients, who will wish acupuncture, will receive this intervention, in addition to standard therapy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Situational anxiety_1
State (situational) anxiety will be measured using State-Trait-Anxiety Inventory (STAI).
Measured: 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
Measured: 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
Measured: Situational anxiety_3 will be measured on the day of surgery immediately before the operation
Secondary outcomes (2)
Heart rate
Measured: On the day of surgery before the surgery
Blood pressure
Measured: On the day of surgery before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656966
- Sponsor's protocol ID
- BB 158/15
- Acronym
- AcuAnx
- Status last verified
- Jun 2016
- First submitted
- 12 Jan 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29986900
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02656966
- Acronym / sponsor ID
- AcuAnx / BB 158/15
- Conditions
- Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular acupuncture + standard therapy | Active comparator | Device: Auricular acupuncturePatients, who will wish acupuncture, will receive this intervention, in addition to standard therapy |
| Standard therapy alone | No intervention | –Patients who do not wish acupuncture will be asked if they will fill in the study questionnaire |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupunctureFive 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. | Device | Auricular acupuncture + standard therapy |
Primary outcome
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
2 secondary outcomes
Heart rate
Time frame: On the day of surgery before the surgery
Blood pressure
Time frame: On the day of surgery before the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Derived from this study: PubMed 29986900Wunsch 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Auricular acupuncture in people with Anxiety, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Situational anxiety_1 (time frame: Situational anxiety_1 will be measured on the day before surgery before auricular acupuncture). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02656966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.