Postoperative Nausea and VomitingsomPONVNCT01875120
Study to Evaluate Anxiety Sensitivity and Somatic Symptoms as Risk Factors for PONV
An observational study of Postoperative Nausea and Vomiting, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients in a universitary hospital who are scheduled for elective surgery in general anesthesia (planned interventions in general surgery, orthopedia, traumatology, gynecology, neurosurgery (except intracranial interventions)and who present with an increased risk to experience postoperative nausea and vomiting.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Johannes Gutenberg University Medical Center, Department of Anesthesiology
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Prospective Observational Study to Evaluate Somatic Symptom Load and Anxiety Sensitivity as Risk Factors for Postoperative Nausea and Vomiting (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.
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Anxiety, Somatoform Disorders
- Medical subject headings
- Postoperative Nausea and Vomiting, Anxiety Disorders, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female patients with increased risk to experience PONV. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of postoperative nausea and vomiting (PONV).
Measured: PONV is assessed in the first 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Laufenberg-Feldmann, M.D., Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875120
- Sponsor's protocol ID
- 837.327.12 (8428-F)
- Acronym
- somPONV
- Status last verified
- Nov 2013
- First submitted
- 7 Jun 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12190791Asmundson 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.
PubMed 8970916Barsky 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.
PubMed 2090830Kisely 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.
PubMed 9300507Spitzer 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.
PubMed 10568646Kroenke 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.
PubMed 11914441Lee 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.
PubMed 17697527Van 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.
PubMed 15845719Watcha 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.
PubMed 1609990Laufenberg-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.
PubMed 30865002
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Evaluate Somatic Symptom Load and Anxiety Sensitivity as Risk Factors for Postoperative Nausea and Vomiting (PONV)
- ClinicalTrials.gov ID
- NCT01875120
- Acronym / sponsor ID
- somPONV / 837.327.12 (8428-F)
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Anxiety, Somatoform Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female patients with increased risk to experience PONV. | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients in a universitary hospital who are scheduled for elective surgery in general anesthesia (planned interventions in general surgery, orthopedia, traumatology, gynecology, neurosurgery (except intracranial interventions)and who present with an increased risk to experience postoperative nausea and vomiting.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of postoperative nausea and vomiting (PONV).
Time frame: PONV is assessed in the first 24 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
- Background: PubMed 12190791Apfel 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.
- Background: PubMed 8970916Asmundson 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.
- Background: PubMed 2090830Barsky 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.
- Background: PubMed 9300507Kisely 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.
- Background: PubMed 10568646Spitzer 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.
- Background: PubMed 11914441Kroenke 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.
- Background: PubMed 17697527Lee 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.
- Background: PubMed 15845719Van 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.
- Background: PubMed 1609990Watcha 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.
- Derived from this study: PubMed 30865002Laufenberg-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea and Vomiting, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of postoperative nausea and vomiting (PONV). (time frame: PONV is assessed in the first 24 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875120, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.