OPS 5-399.5 Implantation or change of venous catheter systems (e.g. for chemotherapy or pain therapy) Patients scheduled for port implantation (independent from underlying disease)
Conditions
Interventions
Group 1: Port implantation with use of virtual reality goggles in addition to local anaesthesia (± iv analgetics/sedation)
Group 2: Conventional port implantation under local anesthesia (± intravenous
Sponsors
Universitätsklinikum Ulm Abteilung für Allgemein- und Viszeralchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Scheduled for elective intravenous port implantation without general anesthesia for any indication 3. Ability to understand the nature and extent of the trial and to give written informed consent. 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. American Society of Anaesthesiologists (ASA) grade > 3 2. Chronic pain 3. Missing cognitive capability of following the virtual reality procedure (e.g. patients with dementia, psychotic episodes or psychiatric pathologies prohibiting VR use) 4. Uncontrolled epilepsy or visually triggered epileptic seizures in the patient's history 5. Auditory and/or visual disorders implying a contraindication for the use of VR 6. Hearing aids and cardiac pacemakers/defibrillators 7. Participation in another intervention-trial with interference of intervention and/or outcome of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peri- and postoperative pain Perioperative anxiety Perioperative drug consumption: consumption of analgesics and sedation | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient’s satisfaction Patient’s tolerability of the procedure Occurrence of postoperative nausea or vomiting Surgeon's satisfaction Duration of procedure Postoperative complications until POD 30 | — |
Countries
Germany
Contacts
Public ContactSandra Graf
Klinik für Allgemein- und ViszeralchirurgieUniversitätsklinikum Ulm
Outcome results
None listed