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

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Postoperative Nausea and Vomiting

Study type: Observational

Funder types: Other

Identifiers

NCT01875120

837.327.12 (8428-F)

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 1 patient group

Female patients with increased risk to experience PONV.