Study to Evaluate Anxiety Sensitivity and Somatic Symptoms as Risk Factors for PONV
NCT ID: NCT01875120
Last Updated: 2013-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
160 participants
OBSERVATIONAL
2012-10-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Female patients with increased risk to experience PONV.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* non-smokers
* must be able to give written informed consent
* planned surgical intervention requiring hospitalisation
* not included in another clinical trial
Exclusion Criteria
* total intravenous anesthesia (TIVA) with propofol
* disability to give written informed consent
* physical or psychic disorders requiring permanent psycho-social care
* no German language skills
18 Years
75 Years
FEMALE
No
Sponsors
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Johannes Gutenberg University Mainz
OTHER
Responsible Party
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Rita Laufenberg-Feldmann, M.D.
Deputy senior physician, head of clinical trial unit
Locations
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Johannes Gutenberg University Medical Center, Department of Anesthesiology
Mainz, Rhineland-Palatinate, Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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837.327.12 (8428-F)
Identifier Type: -
Identifier Source: org_study_id