Clinical Trials Directory

Trials / Completed

CompletedNCT05526976

PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain

Status
Completed
Phase
Study type
Observational
Enrollment
660 (actual)
Sponsor
University Hospital, Antwerp · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Assessment and management for improved wellbeing after elective surgery (PERISCOP³E-Care) Diagnostic assessment tool evaluation and cut-off determination for participation in a transmural perioperative care program

Detailed description

Adult patients (≥ 18y) who are planned to undergo an elective surgery at the University Hospital Antwerp, will be invited to participate. After signing the informed consent, they will be asked to complete questionnaires (PERISCOP3E-care; Kalkman \& modified-Althaus, DN4, HADS, Stait-trait, NRS, MPIn EQ-5D-5L) that involve screening of the risk to develop persistend postoperative pain (PPSP). The questionnaires will be completed via a survey link to the RedCap platform. Invites will be send out via the patient's e-mail. Demograpic data and relevant medical history, surgery history, concomitant medication will be registered. one month and three months post surgery the patients will be contacted to identicate if they developed PPSP. They will also be asked to complete quesionnaires (MPI, HADS, Stai-Trait, NRS, MPI, DN4). Based on this info, the cut-off value will be defined for the preoperative questionnaire. Analysis will be done for the sensitivity and specificity of the questionnaires.

Conditions

Interventions

TypeNameDescription
OTHERPERISCOPE-carePatients with planned elective surgery will be asked to complete the PERISCOP3E-Care questionnaire (modified-Althaus \& Kalkman, DN4, HADS, Stait-trait, NRS, MPI, EQ-5D-5L) preoperative. One month and three months post op the patients will be contacted to check if they developed persistend postoperative pain and they will also complete questionnaires (DN4, HADS, Stait-trait, NRS, MPI and EQ-5D-5L).

Timeline

Start date
2022-12-22
Primary completion
2024-03-06
Completion
2024-03-06
First posted
2022-09-02
Last updated
2024-06-10

Locations

2 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT05526976. Inclusion in this directory is not an endorsement.