AnxietyNCT05141591
Gender-specific Preoperative Anxiety Level and Postoperative Opioid Requirement After ENT Surgery.
An observational study of Anxiety and Acute Post Operative Pain, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The study will be designed to investigate the impact of the preoperative anxiety level on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Acute Post Operative Pain
- What is being tested?
- Anxiety level assessment
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- 11 Nov 2021to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will study ASA physical status I-IV adult subjects, ≥ 18 years of age, scheduled for elective ENT surgeries in the Department of ENT at the Medical University of Vienna. Written informed consent will be obtained from each participant.
Who may be able to join
- American Society of Anesthesiology (ASA) physical status I-IV
- able to read and understand the information sheet and to sign the consent form
- being scheduled for elective ENT surgery under general anesthesia
- written informed consent
- age≥18 years
Who cannot join
- difficulty to understand study procedure, pain scoring system or questionnaires
- surgical procedure warranting elective postoperative ventilation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna
Vienna, State of Vienna, 1090
Marita Windpassinger, MD, +43140400 ext. 41020, marita.windpassinger@meduniwien.ac.at
Olga Plattner, MD, +43140400 ext. 41020, olga.plattner@meduniwien.ac.at
About this study
Official title: The Impact of Gender-specific Preoperative Anxiety Level on Postoperative Opioid Requirement After ENT Surgery.
The study will be designed to investigate the impact of the preoperative anxiety level on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery.
The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.
Read the detailed description
Background Due to the frequency of surgeries, acute postsurgical pain (APSP) is a common clinical problem. In this study, the investigators will investigate pre-surgical psychological factors associated with the experience of APSP in ENT surgery.
The study will be designed to investigate the impact of gender-specific preoperative anxiety states, using the STOA, APAIS, PCS and VAS-A scoring systems, on postoperative opioid consumption after elective ENT surgery.
These findings may have important implications for developing more personalized strategies in acute postoperative pain therapy in selected patients.
Aim Study aim is to investigate the impact of the preoperative anxiety level, using the validated STOA questionnaire, on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery.
The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.
The investigators hypothesize that a higher preoperative anxiety state, is a predictive factor of opioid requirement in the early postoperative period after ENT surgery.
Methods Surgery-related psychological factors like anxiety state will be assessed gender-specific, in patients scheduled for elective ENT surgery by validated questionnaires (STOA, APAIS, PCS and VAS-A), filled out by the patient the day before surgery and on the day of surgery, to investigate the correlation with the postoperative opioid consumption.
- Conditions
- Anxiety, Acute Post Operative Pain
- Being tested
- Anxiety level assessment
- Keywords
- catastrophizing, opioid consumption
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety level assessmentOther
To investigate the impact of psychological variables e.g. pre-surgical anxiety on postoperative opioid consumption and pain level, the investigators will perform the STOA, APAIS, PCS and the VAS-A anxiety questionnaires before surgery.
| Study group | Role | What they receive |
|---|---|---|
| ENT surgical patients | ASA physical status I-IV adult subjects, ≥ 18 years of age, scheduled for elective ENT surgeries in the Department of ENT at the Medical University of Vienna. On the day before elective ENT- surgery patients will be asked to complete self-administered questionnaires (STOA, APAIS, PCS) concerning their emotional and anxiety state. These questionnaires will be re-tested on the day of surgery and opioid consumption during the stay in the recovery room documented. Receives: Other: Anxiety level assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
cumulative opioid consumption within PACU stay
Measured: during the stay in the recovery room assessed up to 2 hours
Secondary outcomes (1)
Postoperative Pain Score-VAS-PACU
mean pain level on an 11-point verbal Likert response score recorded at 30-minute intervals during the PACU stay, ranging between 0 and 10, with higher levels indicating higher pain intensity
Measured: during the stay in the recovery room assessed up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start11 Nov 2021
- Primary completion29 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marita Windpassinger M.D., Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141591
- Sponsor's protocol ID
- 2006/2021
- Status last verified
- Jul 2025
- First submitted
- 10 Nov 2021
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Gender-specific Preoperative Anxiety Level on Postoperative Opioid Requirement After ENT Surgery.
- ClinicalTrials.gov ID
- NCT05141591
- Acronym / sponsor ID
- 2006/2021
- Conditions
- Anxiety, Acute Post Operative Pain
- Keywords
- catastrophizing, opioid consumption
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Dec 2021 (actual)
- 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.
The study will be designed to investigate the impact of the preoperative anxiety level on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery.
The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.
Detailed description
Background Due to the frequency of surgeries, acute postsurgical pain (APSP) is a common clinical problem. In this study, the investigators will investigate pre-surgical psychological factors associated with the experience of APSP in ENT surgery.
The study will be designed to investigate the impact of gender-specific preoperative anxiety states, using the STOA, APAIS, PCS and VAS-A scoring systems, on postoperative opioid consumption after elective ENT surgery.
These findings may have important implications for developing more personalized strategies in acute postoperative pain therapy in selected patients.
Aim Study aim is to investigate the impact of the preoperative anxiety level, using the validated STOA questionnaire, on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery.
The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.
The investigators hypothesize that a higher preoperative anxiety state, is a predictive factor of opioid requirement in the early postoperative period after ENT surgery.
Methods Surgery-related psychological factors like anxiety state will be assessed gender-specific, in patients scheduled for elective ENT surgery by validated questionnaires (STOA, APAIS, PCS and VAS-A), filled out by the patient the day before surgery and on the day of surgery, to investigate the correlation with the postoperative opioid consumption.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENT surgical patients | – | Other: Anxiety level assessmentASA physical status I-IV adult subjects, ≥ 18 years of age, scheduled for elective ENT surgeries in the Department of ENT at the Medical University of Vienna. On the day before elective ENT- surgery patients will be asked to complete self-administered questionnaires (STOA, APAIS, PCS) concerning their emotional and anxiety state. These questionnaires will be re-tested on the day of surgery and opioid consumption during the stay in the recovery room documented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will study ASA physical status I-IV adult subjects, ≥ 18 years of age, scheduled for elective ENT surgeries in the Department of ENT at the Medical University of Vienna. Written informed consent will be obtained from each participant.
Key inclusion criteria (5 listed)
- American Society of Anesthesiology (ASA) physical status I-IV
- able to read and understand the information sheet and to sign the consent form
- being scheduled for elective ENT surgery under general anesthesia
- written informed consent
- age≥18 years
Key exclusion criteria (2 listed)
- difficulty to understand study procedure, pain scoring system or questionnaires
- surgical procedure warranting elective postoperative ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety level assessmentTo investigate the impact of psychological variables e.g. pre-surgical anxiety on postoperative opioid consumption and pain level, the investigators will perform the STOA, APAIS, PCS and the VAS-A anxiety questionnaires before surgery. | Other | ENT surgical patients |
Primary outcome
Opioid consumption
Time frame: during the stay in the recovery room assessed up to 2 hours
cumulative opioid consumption within PACU stay
1 secondary outcome
Postoperative Pain Score-VAS-PACU
Time frame: during the stay in the recovery room assessed up to 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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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.
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 Anxiety and Acute Post Operative Pain, run by Medical University of Vienna at 1 site in Austria.
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 2 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: looking for participants now, as of the sponsor's last update on 4 Jul 2025. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marita Windpassinger, MD (+43 1 40400 41020, marita.windpassinger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: during the stay in the recovery room assessed up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jul 2025.