Skip to main content
OpenTrials
Completed

NCT Number: NCT01875120

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Nausea and Vomiting Anxiety Disorders Mental Disorders Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Somatoform Disorders Vomiting

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Johannes Gutenberg University Medical Center, Department of Anesthesiology

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurrence of postoperative nausea and vomiting (PONV).

    Time frame: PONV is assessed in the first 24 hours after surgery.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

Prospective Observational Study to Evaluate Somatic Symptom Load and Anxiety Sensitivity as Risk Factors for Postoperative Nausea and Vomiting (PONV)

Acronym: somPONV

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2013
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.