Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02656966
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2016-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Acupuncture for Treatment of Preoperative Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020831', 'term': 'Acupuncture, Ear'}], 'ancestors': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055097', 'term': 'Auriculotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-27', 'studyFirstSubmitDate': '2016-01-12', 'studyFirstSubmitQcDate': '2016-01-13', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Situational anxiety_1', 'timeFrame': 'Situational anxiety_1 will be measured on the day before surgery before auricular acupuncture', 'description': 'State (situational) anxiety will be measured using State-Trait-Anxiety Inventory (STAI).'}, {'measure': 'Situational anxiety_2', 'timeFrame': 'Situational anxiety_2 will be measured and in the evening of the day before surgery', 'description': 'State (situational) anxiety will be measured using State-Trait-Anxiety Inventory'}, {'measure': 'Situational anxiety_3', 'timeFrame': 'Situational anxiety_3 will be measured on the day of surgery immediately before the operation', 'description': 'State (situational) anxiety will be measured using State-Trait-Anxiety Inventory'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'On the day of surgery before the surgery'}, {'measure': 'Blood pressure', 'timeFrame': 'On the day of surgery before the surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '29986900', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPatients, 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with an American Society of Anaesthesiologists physical status of I to II scheduled for elective ambulatory gynaecological surgery under standardized general anaesthesia\n2. Surgery time does not exceed 60 minutes\n3. Patients without previous opioid and psychotropic medication\n4. Patients aged between 19 and 55 years, able to fill in the STAI questionnaire\n5. Patients who have given written informed consent\n\nExclusion Criteria:\n\n1. Current psychiatric disease\n2. Local skin infection at the sites of acupuncture\n3. Aged \\< 19 or \\> 55 years\n4. Failure to follow the standardized schema of general anaesthesia\n5. Surgery time more than 60 minutes\n6. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)\n7. Patients who consumed opioid medication at least 6 months before surgery\n8. Patients who are unable to understand the consent form or to fill in the STAI questionnaire'}, 'identificationModule': {'nctId': 'NCT02656966', 'acronym': 'AcuAnx', 'briefTitle': 'Auricular Acupuncture for Treatment of Preoperative Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Auricular Acupuncture vs. Standard Therapy for Treatment of Preoperative Anxiety in Patients Scheduled for Ambulatory Gynaecological Surgery - a Pilot Non-randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BB 158/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Auricular acupuncture + standard therapy', 'description': 'Patients, who will wish acupuncture, will receive this intervention, in addition to standard therapy', 'interventionNames': ['Device: Auricular acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'Standard therapy alone', 'description': 'Patients who do not wish acupuncture will be asked if they will fill in the study questionnaire'}], 'interventions': [{'name': 'Auricular acupuncture', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Auricular acupuncture + standard therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'University Medicine of Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}