Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT01875120
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2013-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Anxiety Sensitivity and Somatic Symptoms as Risk Factors for PONV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-08', 'studyFirstSubmitDate': '2013-06-07', 'studyFirstSubmitQcDate': '2013-06-07', 'lastUpdatePostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of postoperative nausea and vomiting (PONV).', 'timeFrame': 'PONV is assessed in the first 24 hours after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Somatoform Disorders'], 'conditions': ['Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '12190791', 'type': 'BACKGROUND', 'citation': 'Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. doi: 10.1034/j.1399-6576.2002.460801.x.'}, {'pmid': '8970916', 'type': 'BACKGROUND', 'citation': 'Asmundson GJ, Taylor S. Role of anxiety sensitivity in pain-related fear and avoidance. J Behav Med. 1996 Dec;19(6):577-86. doi: 10.1007/BF01904905.'}, {'pmid': '2090830', 'type': 'BACKGROUND', 'citation': 'Barsky AJ, Wyshak G, Klerman GL. The somatosensory amplification scale and its relationship to hypochondriasis. J Psychiatr Res. 1990;24(4):323-34. doi: 10.1016/0022-3956(90)90004-a.'}, {'pmid': '9300507', 'type': 'BACKGROUND', 'citation': 'Kisely S, Goldberg D, Simon G. A comparison between somatic symptoms with and without clear organic cause: results of an international study. Psychol Med. 1997 Sep;27(5):1011-9. doi: 10.1017/s0033291797005485.'}, {'pmid': '10568646', 'type': 'BACKGROUND', 'citation': 'Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.'}, {'pmid': '11914441', 'type': 'BACKGROUND', 'citation': 'Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.'}, {'pmid': '17697527', 'type': 'BACKGROUND', 'citation': 'Lee YY, Kim KH, Yom YH. Predictive models for post-operative nausea and vomiting in patients using patient-controlled analgesia. J Int Med Res. 2007 Jul-Aug;35(4):497-507. doi: 10.1177/147323000703500409.'}, {'pmid': '15845719', 'type': 'BACKGROUND', 'citation': 'Van den Bosch JE, Moons KG, Bonsel GJ, Kalkman CJ. Does measurement of preoperative anxiety have added value for predicting postoperative nausea and vomiting? Anesth Analg. 2005 May;100(5):1525-1532. doi: 10.1213/01.ANE.0000149325.20542.D4.'}, {'pmid': '1609990', 'type': 'BACKGROUND', 'citation': 'Watcha MF, White PF. Postoperative nausea and vomiting. Its etiology, treatment, and prevention. Anesthesiology. 1992 Jul;77(1):162-84. doi: 10.1097/00000542-199207000-00023.'}, {'pmid': '30865002', 'type': 'DERIVED', 'citation': "Laufenberg-Feldmann R, Muller M, Ferner M, Engelhard K, Kappis B. Is 'anxiety sensitivity' predictive of postoperative nausea and vomiting?: A prospective observational study. Eur J Anaesthesiol. 2019 May;36(5):369-374. doi: 10.1097/EJA.0000000000000979."}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study aims to evaluate the influence of somatic symptom load and anxiety sensitivity as risk factors for the occurrence of postoperative nausea and vomiting (PONV). Physiological and psychological variables are assessed in female patients with an increased risk for PONV prior to a planned surgical intervention with a 33-item questionnaire composed of the ASI-3 and the PHQ-15. Postoperative evaluation includes the occurrence of nausea and vomiting in the first 24 hours after surgery. It is hypothesized that patients with high sum scores for somatic symptom load (measured with the Patient Health Questionnaire, PHQ-15) and with increased levels for anxiety sensitivity (measured with the Anxiety Sensitivity Index, ASI-3) experience more frequently postoperative nausea and vomiting (PONV) than patients with low scores in both self-rating instruments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients in a universitary hospital who are scheduled for elective surgery in general anesthesia (planned interventions in general surgery, orthopedia, traumatology, gynecology, neurosurgery (except intracranial interventions)and who present with an increased risk to experience postoperative nausea and vomiting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients 18-75 years\n* non-smokers\n* must be able to give written informed consent\n* planned surgical intervention requiring hospitalisation\n* not included in another clinical trial\n\nExclusion Criteria:\n\n* emergency intervention\n* total intravenous anesthesia (TIVA) with propofol\n* disability to give written informed consent\n* physical or psychic disorders requiring permanent psycho-social care\n* no German language skills'}, 'identificationModule': {'nctId': 'NCT01875120', 'acronym': 'somPONV', 'briefTitle': 'Study to Evaluate Anxiety Sensitivity and Somatic Symptoms as Risk Factors for PONV', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Prospective Observational Study to Evaluate Somatic Symptom Load and Anxiety Sensitivity as Risk Factors for Postoperative Nausea and Vomiting (PONV)', 'orgStudyIdInfo': {'id': '837.327.12 (8428-F)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female patients with increased risk to experience PONV.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Johannes Gutenberg University Medical Center, Department of Anesthesiology', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy senior physician, head of clinical trial unit', 'investigatorFullName': 'Rita Laufenberg-Feldmann, M.D.', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}