Elective SurgerySCOPENCT07158684
Surgical COrncerns and Psychological Evaluation of Patients Undergoing Elective Surgery
A study testing Semi-structured interview in people with Elective Surgery and Anxiety, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
This study wants to obtain more information regarding the patient's concerns since concerns of the patient about the procedure is found as a predictor for the development of chronic post-surgical pain. This step is crucial in translating early identification of a high-risk population into preventive policies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgery, Anxiety, Chronic Post Surgical Pain
- What is being tested?
- Semi-structured interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2025to 1 Sep 2027
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Dutch speaking
- With a planned elective surgery, at the Antwerp University Hospital
- Score of ≥ 11 on APAIS anxiety subscale
- Must be able to complete questions on a tablet (digital literacy)
- Signed informed consen (prescreening informed consent and study participation informed consent)
Who cannot join
- Diagnostic procedures requiring anaesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Antwerp
Edegem, Antwerpen, 2650
About this study
Official title: Psychological Evaluation of Patients Undergoing Elective Surgery With Anxiety and Surgical Concerns: a Qualitative Interview Study
This study wants to obtain more information regarding the patient's concerns since concerns of the patient about the procedure is found as a predictor for the development of chronic post-surgical pain. This step is crucial in translating early identification of a high-risk population into preventive policies. Using a semi-structured interview, the investigators aim to gather this additional information, which is essential in the development of an (individualized) biopsychosocial care pathway in the future.
- Conditions
- Elective Surgery, Anxiety, Chronic Post Surgical Pain
- Being tested
- Semi-structured interview
- 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.
Semi-structured interviewOther
A qualitative semi-structured interview of the patient's anxiety before and one month after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Semi-structured interview | Experimental | A qualitative semi-structured interview of the patient's anxiety before and one month after surgery. Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploration of anxiety in patients undergoing elective surgery
Thematic analysis of the semi-structured interview response.
Measured: before and one month after surgery
Secondary outcomes (5)
To determine self-reported anxiety level regarding the surgical procedure before surgery.
by Amsterdam Preoperative Anxiety and Information Scale (APAIS) including six questionnaires (for anxiety and need for information). Scale ranging from 6-30. The higher the score the more anxiety and/or need for information.
Measured: From enrollment to pre-surgical visit
To explore self-reported general depression level measured before surgery.
Beck Depression Inventory (BDI-2-NL)
Measured: between pre-surgical visit and the day of surgery (Day 0)
To explore self-reported general anxiety level measured before surgery.
State-Trait Anxiety Inventory (STAI-Trait)
Measured: between pre-surgical visit and the day of surgery (Day 0)
To explore self-reported moment-specific anxiety levels measured before and after surgery.
by State-Trait Anxiety Inventory (STAI-State)
Measured: before surgery on the pre-surgical visit and 1 month after surgery
To explore pain intensity of the surgical site in patients before and after surgery
by Numerical Rating Scale (NRS)
Measured: before surgery on the pre-surgical visit and 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Nov 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davina Wildemeersch, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158684
- Sponsor's protocol ID
- 004382
- Acronym
- SCOPE
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Evaluation of Patients Undergoing Elective Surgery With Anxiety and Surgical Concerns: a Qualitative Interview Study
- ClinicalTrials.gov ID
- NCT07158684
- Acronym / sponsor ID
- SCOPE / 004382
- Conditions
- Elective Surgery, Anxiety, Chronic Post Surgical Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 8 Sep 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.
This study wants to obtain more information regarding the patient's concerns since concerns of the patient about the procedure is found as a predictor for the development of chronic post-surgical pain. This step is crucial in translating early identification of a high-risk population into preventive policies. Using a semi-structured interview, the investigators aim to gather this additional information, which is essential in the development of an (individualized) biopsychosocial care pathway in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semi-structured interview | Experimental | Other: Semi-structured interviewA qualitative semi-structured interview of the patient's anxiety before and one month after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years old
- Dutch speaking
- With a planned elective surgery, at the Antwerp University Hospital
- Score of ≥ 11 on APAIS anxiety subscale
- Must be able to complete questions on a tablet (digital literacy)
Key exclusion criteria (1 listed)
- Diagnostic procedures requiring anaesthesia
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 |
|---|---|---|
| Semi-structured interviewA qualitative semi-structured interview of the patient's anxiety before and one month after surgery. | Other | Semi-structured interview |
Primary outcome
Exploration of anxiety in patients undergoing elective surgery
Time frame: before and one month after surgery
Thematic analysis of the semi-structured interview response.
5 secondary outcomes
To determine self-reported anxiety level regarding the surgical procedure before surgery.
Time frame: From enrollment to pre-surgical visit
To explore self-reported general depression level measured before surgery.
Time frame: between pre-surgical visit and the day of surgery (Day 0)
To explore self-reported general anxiety level measured before surgery.
Time frame: between pre-surgical visit and the day of surgery (Day 0)
To explore self-reported moment-specific anxiety levels measured before and after surgery.
Time frame: before surgery on the pre-surgical visit and 1 month after surgery
To explore pain intensity of the surgical site in patients before and after surgery
Time frame: before surgery on the pre-surgical visit and 1 month after surgery
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 13 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured interview in people with Elective Surgery and Anxiety, run by University Hospital, Antwerp at 1 site in Belgium.
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 6 inclusion and 1 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 13 Oct 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 Belgium. 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 Eva Wauters, Master (+32034368165, eva.wauters@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploration of anxiety in patients undergoing elective surgery (time frame: before and one month after surgery). 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 13 Oct 2026.