Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-29 @ 4:11 AM
Study NCT ID:
NCT01420835
Status:
COMPLETED
Last Update Posted:
2013-01-21
First Post:
2011-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese Auriculotherapy on Stress and Quality of Life in Nursing Professionals: Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055097', 'term': 'Auriculotherapy'}, {'id': 'D020831', 'term': 'Acupuncture, Ear'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-17', 'studyFirstSubmitDate': '2011-08-19', 'studyFirstSubmitQcDate': '2011-08-19', 'lastUpdatePostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stress levels', 'timeFrame': '75 days', 'description': 'The measurement of stress levels will be performed by List of Stress Symptoms (Vasconcellos) and the main symptoms'}], 'secondaryOutcomes': [{'measure': 'quality of life domains', 'timeFrame': '75 days', 'description': 'The assessment of life quality domains will be done by SF36v2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stress', 'Quality of life'], 'conditions': ['Stress', 'Quality of Life']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Giaponesi ANL, Leão ER. Auriculotherapy as an intervention to reduce stress reduction among the nursing team in intensive care. Nursing (São Paulo);12(139):575-579, dez. 2009. ilus.'}, {'pmid': '25029046', 'type': 'DERIVED', 'citation': 'Kurebayashi LF, Silva MJ. Efficacy of Chinese auriculotherapy for stress in nursing staff: a randomized clinical trial. Rev Lat Am Enfermagem. 2014 May-Jun;22(3):371-8. doi: 10.1590/0104-1169.3239.2426.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess stress levels and quality of life in the nursing team of Samaritan Hospital and evaluate the effectiveness of Chinese auriculotherapy used with and without closed protocol on reducing the stress levels and improvement of life quality.', 'detailedDescription': 'Based on the positive results achieved in a preliminary study conducted in January and February 2010, entitled "Applicability of auricular needles or seeds for the reduction of stress in nursing professionals" at the University Hospital, emerged from this research project in order to extend the first study, with a more representative sample and with a design that would allow further discussions on the effectiveness of Chinese auricular needles semi-permanent to reduce stress and thereby improving the quality of life of nursing professionals. This clinical trial aims, above all, compare the results of the technique with the use of closed protocol and a group without protocol. The latter, however, shall be based on energy evaluation according to Traditional Chinese Medicine (TCM) and the course of treatment will be performed similarly to the clinical practice commonly performed by traditional practitioners, that is, individually, not necessarily repetitive and whose continuation is achieved depending on the answers to each treatment.\n\nDiscussions are justified about protocol and no protocol research in complementary and integrative practices, since the methodologies proposed and accepted by the scientific community does not always seem to be appropriate tools for evaluating therapies like those coming from the East. The transfer of the Western conception of research according to positivist principles are not always consistent with the principles underlying the complementary and alternative therapies, and in particular the practice from China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nScore by the List of Stress Symptoms (40 to 95 points)\n\nVoluntary participation in the study\n\nAvailability of time for submission to the sessions\n\nExclusion Criteria:\n\nPregnancy\n\nMedical license or vacation during the period\n\nIf they perform another chinese treatment like a massage, acupuncture, moxibustion etc'}, 'identificationModule': {'nctId': 'NCT01420835', 'briefTitle': 'Chinese Auriculotherapy on Stress and Quality of Life in Nursing Professionals: Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Randomized Clinical Trial: Chinese Auriculotherapy With and Without Protocol on Stress and Quality of Life in Nursing Professionals', 'orgStudyIdInfo': {'id': 'SISNEP CAAE 0050.0.196.196-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Without Protocol Group', 'description': 'The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.\n\nFive points will be chosen to treat stress according to the symptoms and Chinese diagnosis.', 'interventionNames': ['Other: without protocol group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Auriculotherapy with protocol', 'description': 'Auriculotherapy with stress protocol points. Five points are indicated for stress (Liver yang1, Liver yang2, Shenmen, Brainstem and Kidney).', 'interventionNames': ['Other: Auriculotherapy (protocol group)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': "Control Group won't receive any treatment and will be evaluated at the same time and the same way of interventions group"}], 'interventions': [{'name': 'Auriculotherapy (protocol group)', 'type': 'OTHER', 'otherNames': ['auricular acupuncture'], 'description': 'The auriculotherapy points of the protocol group will be 5 points (Liver yang1, Liver yang2, Shenmen, Kidney, Brainstem), during 45 days, twice per week, 12 sessions and assessment of the follow-up (30 days) after finishing the treatment.', 'armGroupLabels': ['Auriculotherapy with protocol']}, {'name': 'without protocol group', 'type': 'OTHER', 'otherNames': ['auricular acupuncture'], 'description': 'The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion. Five points will be chosen to treat stress according to the symptoms and the Chinese diagnosis.', 'armGroupLabels': ['Without Protocol Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01323-001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Samaritan Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Leonice FS Kurebayashi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Terapia Integrada e Oriental'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sociedade Hospital Samaritano', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Leonice Fumiko Sato Kurebayashi', 'investigatorFullName': 'Leonice Fumiko Sato Kurebayashi', 'investigatorAffiliation': 'University of Sao Paulo'}}}}