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NCT Number: NCT07158684

Surgical COrncerns and Psychological Evaluation of Patients Undergoing Elective Surgery

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.

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Key information

Conditions

Elective Surgery Anxiety Anxiety Disorders Chronic Post Surgical Pain Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Antwerp

Edegem, Antwerpen, 2650, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semi-structured interview

Other

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

Primary outcomes

  1. Exploration of anxiety in patients undergoing elective surgery

    Time frame: before and one month after surgery

    Thematic analysis of the semi-structured interview response.

Secondary outcomes

  1. To determine self-reported anxiety level regarding the surgical procedure before surgery.

    Time frame: From enrollment to pre-surgical visit

    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.

  2. To explore self-reported general depression level measured before surgery.

    Time frame: between pre-surgical visit and the day of surgery (Day 0)

    Beck Depression Inventory (BDI-2-NL)

  3. To explore self-reported general anxiety level measured before surgery.

    Time frame: between pre-surgical visit and the day of surgery (Day 0)

    State-Trait Anxiety Inventory (STAI-Trait)

  4. 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

    by State-Trait Anxiety Inventory (STAI-State)

  5. 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

    by Numerical Rating Scale (NRS)

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Wauters, Master

CONTACT

[email protected]

+32034368165

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Acronym: SCOPE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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