Anxietyanti-anxietyNCT07291466
Assessment of Preoperative Anxiety and Evaluation of Calming Interventions: Anonymous Patient Survey
An observational study of Anxiety, run by Vera Guttenthaler at 1 site in Germany.
Trial summary
The aim of this study is to better understand the anxiety of patients before elective surgeries and to investigate which measures for calming are perceived as helpful or pleasant. Adult, German-speaking patients (≥18 years) in the elective surgical setting at UKB are invited to participate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- How many people
- 750 participants
- Where
- 1 siteGermany
- Study dates
- 30 Sep 2025to 30 Jan 2026
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult, German-speaking patients (≥18 years) in the elective surgical setting at UKB are invited to participate.
Who may be able to join
- Adults (≥18 years),
- German-speaking patients
- elective surgical setting
Who cannot join
- emergency surgery
- Patients with documented psychiatric disorders or confusion
- Individuals admitted under a court or official mandate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erhebung Von präoperativer Ängstlichkeit Und Bewertung Beruhigender Maßnahmen: Anonyme Patientenbefragung
The aim of this study is to better understand the anxiety of patients before elective surgeries and to investigate which measures for calming are perceived as helpful or pleasant. Adult, German-speaking patients (≥18 years) in the elective surgical setting at UKB are invited to participate. It is planned that at least 400 patients will take part in the survey. The survey is conducted anonymously, voluntarily, and without the collection of personal data. This is a purely observational study without any intervention.
Read the detailed description
Patients who come to the premedication outpatient clinic are invited in the waiting area to participate in this anonymous written survey. Participation is voluntary. The survey takes approximately 10-15 minutes. No personal data are collected.
Anxiety is assessed using the State-Trait Operation Anxiety (STOA) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaires.
To address anxiety reduction, various possible measures are listed, and patients are asked to check all the options they consider helpful and appropriate. They are also given the opportunity to add further suggestions that are not included in the list.
- Conditions
- Anxiety
- Keywords
- Operation, anxiety, pain
- Medical subject headings
- Anxiety Disorders, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Record patients' stated preferences related to anxiety management.
using multiple-choice and open-ended responses
Measured: baseline
Secondary outcomes (2)
Assess patients' preoperative anxiety
Using the STOA questionnaire. The STOA evaluates anxiety on two levels: the long-term, personality-related tendency toward surgical anxiety (trait) and the current state of anxiety (state), with cognitive and affective components. The STOA-State scale includes 10 items rated on a 4-point scale from 0 ("Not at all") to 3 ("Very much"), yielding a total score of 0-30. The STOA-Trait scale includes 20 items rated from 0 ("Almost never") to 3 ("Almost always"), with a total score of 0-60.
Measured: baseline
Assess patients' preoperative anxiety
Using APAIS questionnaire. The APAIS is a validated, brief instrument with 20 items, assessing anxiety related to anesthesia and the surgical procedure. Anxiety scores range from 4 (no anxiety) to 20 (high anxiety), and the total score ranges from 6 to 30.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start30 Sep 2025
- Primary completion15 Jan 2026
- Study completion30 Jan 2026
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.
- 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
- 750 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Vera Guttenthaler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vera Guttenthaler, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291466
- Sponsor's protocol ID
- 2025-290-BO
- Acronym
- anti-anxiety
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 27 Apr 2026
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erhebung Von präoperativer Ängstlichkeit Und Bewertung Beruhigender Maßnahmen: Anonyme Patientenbefragung
- ClinicalTrials.gov ID
- NCT07291466
- Acronym / sponsor ID
- anti-anxiety / 2025-290-BO
- Conditions
- Anxiety
- Keywords
- Operation, anxiety, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Vera GuttenthalerUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 18 Dec 2025 (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 aim of this study is to better understand the anxiety of patients before elective surgeries and to investigate which measures for calming are perceived as helpful or pleasant. Adult, German-speaking patients (≥18 years) in the elective surgical setting at UKB are invited to participate. It is planned that at least 400 patients will take part in the survey. The survey is conducted anonymously, voluntarily, and without the collection of personal data. This is a purely observational study without any intervention.
Detailed description
Patients who come to the premedication outpatient clinic are invited in the waiting area to participate in this anonymous written survey. Participation is voluntary. The survey takes approximately 10-15 minutes. No personal data are collected.
Anxiety is assessed using the State-Trait Operation Anxiety (STOA) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaires.
To address anxiety reduction, various possible measures are listed, and patients are asked to check all the options they consider helpful and appropriate. They are also given the opportunity to add further suggestions that are not included in the list.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, German-speaking patients (≥18 years) in the elective surgical setting at UKB are invited to participate.
Key inclusion criteria (3 listed)
- Adults (≥18 years),
- German-speaking patients
- elective surgical setting
Key exclusion criteria (3 listed)
- emergency surgery
- Patients with documented psychiatric disorders or confusion
- Individuals admitted under a court or official mandate
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
Record patients' stated preferences related to anxiety management.
Time frame: baseline
using multiple-choice and open-ended responses
2 secondary outcomes
Assess patients' preoperative anxiety
Time frame: baseline
Assess patients' preoperative anxiety
Time frame: baseline
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 27 Apr 2026.
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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 Anxiety, run by Vera Guttenthaler 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 3 inclusion and 3 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 27 Apr 2026. 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?
Record patients' stated preferences related to anxiety management. (time frame: baseline). 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 27 Apr 2026.