Radboud university medical center
Nijmegen, Netherlands
NCT Number: NCT03933124
This study evaluates the effect of Virtual Reality (VR) on pain and recovery in 100 post-operative patients. 60 patients will be included in the intervention group; they will use VR minimal 3 times a day on day 2-4 after surgery, on the surgical ward, as an add-on intervention next to standard care. 40 patients in the control group will only receive standard postoperative care.
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Notify Me16 year and older
All sexes
Interventional
Not applicable
Nijmegen, Netherlands
Adequate management of post-surgical pain (PSP) may contribute to improved clinical and socioeconomic outcomes. Facilitating an adequate level of PSP relief is a challenging problem: the analgesics that are most frequently used, for example, opioids and non-steroidal anti-inflammatory drugs (NSAIDs), often come with side effects and do not always provide sufficient pain relief. Therefore, pain management is increasingly focusing on (additional) non-pharmacological analgesics, including Virtual Reality (VR).
VR immerses the user in a virtual world through a head mounted device (HMD). VR is, among other things, taught to be effective through distraction: it diverts attention away from the nociceptive input, resulting in less available attention for pain perception. In both clinical and experimental studies, VR has shown to be effective in reducing pain, anxiety and stress.
Although this distraction method is increasingly studied in the past years, VR pain relief has mostly been investigated as an intervention during painful procedures in specific research populations. For example, VR has been studied during wound dressing changes in burn wound patients in children and adolescents, during venipuncture in children or during dental treatments. Furthermore, most VR studies used VR as a single intervention, measuring pre-post differences in pain scores or used a cross over design with one VR session and one control session. It is interesting to know whether VR is effective in reducing postoperative pain during more than one VR session. More research is needed in larger trials evaluating a broad sample of the general population including elderly, as the common hospitalized patient is of an older age nowadays. Finally, it is important to evaluate the feasibility and acceptability of VR in postoperative patients and to know whether there are predictive factors to select patients who can mostly benefit from VR interventions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4.
Other names: Relaxmaker, Oculus Go, CareVRx
Time frame: day 1-4, the first four postoperative days on the surgical ward
Pain on average in the last 24h. VAS (visual analogue scale): 0-100 mm, 0 is defined as "no pain at all", 100 is "the worst pain the patient can imagine".
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Time to 30% pain reduction compared to pain scores on postoperative day 1.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Worst pain in the last 24h.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
NRS score (Numeric Rating Scale): 0-10. 0 is defined as "no pain at all", 10 is "the worst pain the patient can imagine".
Time frame: Day 2-4 on the surgical ward.
Pain pre- and postintervention in the VR intervention group.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Quality of recovery -15 questionnaire.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Anxiety on average in the last 24h.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Stress on average in the last 24h.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
State-Trait Anxiety Inventory (STAI)-6 questionnaire.
Time frame: Day 2-4 on the surgical ward.
Anxiety pre- and postintervention in the VR intervention group.
Time frame: Day 2-4 on the surgical ward.
Stress pre- and postintervention in the VR intervention group.
Time frame: Day 2-4 on the surgical ward.
Depression pre- and postintervention in the VR intervention group.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Analgesic use (paracetamol, NSAIDs, opioids, use of add-on/escape medication, daily defined dose of opioid, days to removal of epidural analgesia or PCA (patient-controlled intravenous analgesia, morphine IV), days to converting from opioids to NSAIDs or paracetamol without opioids).
Time frame: Day 1-4 postoperative
Questionnaire, interview
Time frame: Day 1-4 postoperative
Questionnaire, interview
Time frame: Day 1-4 postoperative
Questionnaire, interview
Radboud University Medical Center
Other
Acronym: VIRTUAL
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