Surgical COrncerns and Psychological Evaluation of Patients Undergoing Elective Surgery

Not Applicable

Not yet recruiting

• Conditions: Elective Surgery; Anxiety; Chronic Post Surgical Pain

• Registration Number: NCT07158684
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Start: 2025-09-15
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Exploration of anxiety in patients undergoing elective surgery	before and one month after surgery	Thematic analysis of the semi-structured interview response.

Secondary Outcome Measures

Name	Time	Method
To determine self-reported anxiety level regarding the surgical procedure before surgery.	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.
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 surgery	by State-Trait Anxiety Inventory (STAI-State)
To explore pain intensity of the surgical site in patients before and after surgery	before surgery on the pre-surgical visit and 1 month after surgery	by Numerical Rating Scale (NRS)

Trial Locations

Locations (1)

University Hospital of Antwerp; 🇧🇪 Edegem, Antwerpen, Belgium