Surgical COrncerns and Psychological Evaluation of Patients Undergoing Elective Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old
Dutch speaking
With a planned elective surgery, at the Antwerp University Hospital
Score of ≥ 11 on APAIS anxiety subscale
Disqualifiers
Diagnostic procedures requiring anaesthesia
Trial design
Design model
Single group
Treatments tested in this trial
Semi-structured interview
Other interventionA qualitative semi-structured interview of the patient's anxiety before and one month after surgery.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Semi-structured interviewExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Exploration of anxiety in patients undergoing elective surgery
Thematic analysis of the semi-structured interview response.
Time frame
before and one month after surgerySecondary outcomes
1
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.
Time frame
From enrollment to pre-surgical visit2
To explore self-reported general depression level measured before surgery.
Beck Depression Inventory (BDI-2-NL)
Time frame
between pre-surgical visit and the day of surgery (Day 0)3
To explore self-reported general anxiety level measured before surgery.
State-Trait Anxiety Inventory (STAI-Trait)
Time frame
between pre-surgical visit and the day of surgery (Day 0)4
To explore self-reported moment-specific anxiety levels measured before and after surgery.
by State-Trait Anxiety Inventory (STAI-State)
Time frame
before surgery on the pre-surgical visit and 1 month after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov