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Surgical COrncerns and Psychological Evaluation of Patients Undergoing Elective Surgery

Psychological Evaluation of Patients Undergoing Elective Surgery With Anxiety and Surgical Concerns: a Qualitative Interview Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07158684
Acronym
SCOPE
Enrollment
30
Registered
2025-09-08
Start date
2025-11-15
Completion date
2026-09-01
Last updated
2026-04-29

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

Conditions

Anxiety, Chronic Post Surgical Pain, Elective Surgery

Brief 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. 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.

Interventions

OTHERSemi-structured interview

A qualitative semi-structured interview of the patient's anxiety before and one month after surgery.

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥ 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)

Exclusion criteria

* Diagnostic procedures requiring anaesthesia

Design outcomes

Primary

MeasureTime frameDescription
Exploration of anxiety in patients undergoing elective surgerybefore and one month after surgeryThematic analysis of the semi-structured interview response.

Secondary

MeasureTime frameDescription
To determine self-reported anxiety level regarding the surgical procedure before surgery.From enrollment to pre-surgical visitby 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.
To explore self-reported general depression level measured before surgery.between pre-surgical visit and the day of surgery (Day 0)Beck Depression Inventory (BDI-2-NL)
To explore self-reported general anxiety level measured before surgery.between pre-surgical visit and the day of surgery (Day 0)State-Trait Anxiety Inventory (STAI-Trait)
To explore self-reported moment-specific anxiety levels measured before and after surgery.before surgery on the pre-surgical visit and 1 month after surgeryby State-Trait Anxiety Inventory (STAI-State)
To explore pain intensity of the surgical site in patients before and after surgerybefore surgery on the pre-surgical visit and 1 month after surgeryby Numerical Rating Scale (NRS)

Countries

Belgium

Contacts

CONTACTEva Wauters, Master
eva.wauters@uza.be+32034368165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026