Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-04 @ 10:26 PM
Study NCT ID:
NCT07010003
Status:
RECRUITING
Last Update Posted:
2025-06-08
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019050', 'term': 'Acupressure'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Preoperative (Day 1)', 'description': 'State-Trait Anxiety Inventory - state (STAI-s) The range of possible scores varies from a minimum of 20 to a maximum of 80, where higher scores represent higher anxiety.'}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Baseline (Day 0, preoperative), Immediately after the acupressure session (Day 0, preoperative), Postoperative (Day 2 - Day 10 daily until discharged from hospital, on average 10 days)', 'description': 'State-Trait Anxiety Inventory - state (STAI-s) The range of possible scores varies from a minimum of 20 to a maximum of 80, where higher scores represent higher anxiety.'}, {'measure': 'Specific preoperative anxiety', 'timeFrame': 'Baseline (Day 0, preoperative), Immediately after the acupressure session (Day 0, preoperative), Preoperative (Day 1)', 'description': 'Amsterdam Preoperative Anxiety and Information Scale (APAIS) For the anxiety subscale, scores range between 4 and 20, higher scores reflect higher anxiety.\n\nFor the need for information subscale, scores range between 2 and 10, higher scores reflect higher need for information'}, {'measure': 'Quality of life', 'timeFrame': 'Baseline (Day 0, preoperative), Discharge from hospital (Day 10 on average)', 'description': 'EQ5D'}, {'measure': 'Pain intensity', 'timeFrame': 'Baseline (Day 0, preoperative), Postoperative (Day 2 - Day 10 daily until discharged from hospital', 'description': 'Numerical Rating Scale Scores range between 0 and 10, higher scores indicate higher pain intensity'}, {'measure': 'Depression', 'timeFrame': 'baseline (Day 0, preoperative)', 'description': 'Beck Depression Inventory (BDI) Scores range between 0 and 63, with higher scores representing more severe depression symptoms.'}, {'measure': 'Postoperative Nausea and Vomiting', 'timeFrame': 'Postoperative (Day 2)', 'description': 'PONV'}, {'measure': 'Major Adverse Cardiac and Cerebrovascular Events', 'timeFrame': 'Discharge from hospital (Day 10 on average)', 'description': 'MACCE'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elective Heart Surgery']}, 'descriptionModule': {'briefSummary': 'Acupuncture and acupressure, rooted in Traditional Chinese Medicine, are used to treat a variety of symptoms. One specific and easy-to-apply method is ear acupuncture/acupressure following the NADA protocol (developed by the National Acupuncture Detoxification Association in 1985 in New York). This technique has been used successfully in Germany since 1995. It is known for its balancing and stabilizing effects on both body and mind, helping to reduce symptoms such as anxiety and stress, and promoting relaxation and inner calm.\n\nOpen-heart surgery can be emotionally overwhelming for patients, often triggering intense existential fears. Preoperative anxiety may worsen physical and psychological symptoms and negatively affect surgery outcomes. Therefore, non-pharmacological interventions like acupuncture are gaining importance alongside medication.\n\nSeveral studies have demonstrated the effectiveness of preoperative acupuncture in reducing pain, anxiety, and nausea across various surgeries. Randomized trials show significant anxiety reduction through both body and ear acupuncture. One study found that ear acupuncture can rapidly improve psychological well-being, with effects noticeable within five minutes. This suggests its potential use not only the day before surgery but also immediately beforehand.\n\nIn contrast, research on ear acupressure before heart surgery is limited. However, one study reported improvements in sleep quality and reduced anxiety. A recent review highlighted the positive effects of ear stimulation on stress, blood pressure, and heart rate, and even suggested that acupressure may be more effective than acupuncture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients who are capable of giving consent or willing to do so and who are undergoing elective heart surgery at the Robert Bosch Krankenhaus study center are included.\n\nExclusion Criteria:\n\n* Under 18 years old\n* Emergency or urgent surgery\n* Patients who are incapable of giving consent or unwilling to do so\n* Patients who have received acupuncture treatment (including NADA ear acupuncture or acupressure) in the last three months'}, 'identificationModule': {'nctId': 'NCT07010003', 'briefTitle': 'Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery', 'orgStudyIdInfo': {'id': '643/2024BO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Standard preoperative care'}, {'type': 'EXPERIMENTAL', 'label': 'NADA-Acupressure', 'description': 'Participants in the intervention arm of the study receive standardized ear acupressure treatment according to the NADA protocol before surgery.', 'interventionNames': ['Procedure: Acupressure']}], 'interventions': [{'name': 'Acupressure', 'type': 'PROCEDURE', 'description': 'Ear acupressure following the NADA Protocol is carried out using special acupuncture patches that press a small bead onto defined points on the ear: Shen Men, kidney, lung, liver, and vegetative. NADA ear acupressure is a non-invasive and low-risk intervention. In addition, the protocol is carried out exclusively by NADA-certified doctors, medical assistants, or nursing staff.', 'armGroupLabels': ['NADA-Acupressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70376', 'city': 'Stuttgart', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nora Göbel, Priv.-Doz. Dr. med.', 'role': 'CONTACT', 'email': 'nora.goebel@rbk.de', 'phone': '+49 711 8101 3650'}], 'facility': 'Robert Bosch Krankenhaus', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'centralContacts': [{'name': 'Nora Göbel, Priv.-Doz. Dr. med.', 'role': 'CONTACT', 'email': 'nora.goebel@rbk.de', 'phone': '+49 711 8101 3650'}], 'overallOfficials': [{'name': 'Nora Göbel, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert Bosch Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Bosch-Krankenhaus Stuttgart', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}