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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01875120

Acronym

somPONV

Enrollment

160

Registered

2013-06-11

Start date

2012-10-31

Completion date

2013-10-31

Last updated

2013-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

Anxiety, Somatoform Disorders

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Countries

Germany

Outcome results