Surgical COrncerns and Psychological Evaluation of Patients Undergoing Elective Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semi-structured interview.
- Who it may be relevant to
- Registry conditions: Elective Surgery, Anxiety, Chronic Post Surgical Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Psychological Evaluation of Patients Undergoing Elective Surgery With Anxiety and Surgical Concerns: a Qualitative Interview Study
Overview
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
- Other Semi-structured interview
A qualitative semi-structured interview of the patient's anxiety before and one month after surgery.
Primary outcome measures
- Exploration of anxiety in patients undergoing elective surgery [Time frame: before and one month after surgery]
Secondary outcome measures (5)
- To determine self-reported anxiety level regarding the surgical procedure before surgery. [Time frame: From enrollment to pre-surgical visit]
- To explore self-reported general depression level measured before surgery. [Time frame: between pre-surgical visit and the day of surgery (Day 0)]
- To explore self-reported general anxiety level measured before surgery. [Time frame: between pre-surgical visit and the day of surgery (Day 0)]
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- University Hospital of Antwerp — Edegem
Identifiers
NCT: NCT07158684 · 004382