Surgical COrncerns and Psychological Evaluation of Patients Undergoing Elective Surgery

NCT07158684 | Recruiting DMC

• 1 other identifier: 004382
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Elective Surgery; Anxiety; Chronic Post Surgical Pain

Outcome Measures

Primary Outcomes (1)

• Exploration of anxiety in patients undergoing elective surgery

  Thematic analysis of the semi-structured interview response.

  before and one month after surgery

Secondary Outcomes (5)

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

  From enrollment to pre-surgical visit

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

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

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

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

• 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

• 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

Study Arms (1)

Semi-structured interview

EXPERIMENTAL

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

Other: Semi-structured interview

Interventions

Semi-structured interview OTHER

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

Semi-structured interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• Diagnostic procedures requiring anaesthesia

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital of Antwerp

Edegem, Antwerpen, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Eva Wauters, Master

CONTACT

+32034368165; eva.wauters@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: September 8, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-07

Locations

BE (1)