Study to Evaluate Anxiety Sensitivity and Somatic Symptoms as Risk Factors for PONV

Completed

• Conditions: Postoperative Nausea and Vomiting

• Registration Number: NCT01875120
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• female patients 18-75 years
• non-smokers
• must be able to give written informed consent
• planned surgical intervention requiring hospitalisation
• not included in another clinical trial

Exclusion Criteria

• emergency intervention
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of postoperative nausea and vomiting (PONV).	PONV is assessed in the first 24 hours after surgery.

Trial Locations

Locations (1)

Johannes Gutenberg University Medical Center, Department of Anesthesiology; 🇩🇪 Mainz, Rhineland-Palatinate, Germany