An interventional study of Virtual Reality in Pain, Post-surgical Pain and Pain Management, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 100 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
The intervention group includes 60 patients who will use Virtual Reality for postoperative pain. Participants will use Virtual Reality minimal 10 minutes, minimal 3 times a day on the second, third and fourth day after surgery, on the general ward. * 20 participants will receive an Oculus Go immersive 3D nature videos, games, meditation videos, google earth experiences and sports games. * 20 participants will receive a Relaxmaker with 2D nature videos * 20 participants will receive CareVRx with 3D nature videos and meditation videos.
Device: Virtual Reality
The control group receives standard postoperative care.
The Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4.
Also known as: Relaxmaker, Oculus Go, CareVRx
Mean Daily pain score (VAS, visual analogue scale)
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 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.
Mean Daily worst pain score (VAS)
Worst pain in the last 24h.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Effect of pain on mobility (NRS, Numeric Rating Scale)
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 1-4, the first four postoperative days on the surgical ward.
Difference in pain scores pre- and post- VR intervention (VAS)
Pain pre- and postintervention in the VR intervention group.
Time frame: Day 2-4 on the surgical ward.
Quality of recovery -15 questionnaire.
Quality of recovery -15 questionnaire.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Mean Daily Anxiety score (VAS).
Anxiety on average in the last 24h.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Mean Daily Stress score (VAS)
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.
State-Trait Anxiety Inventory (STAI)-6 questionnaire.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Difference in anxiety scores pre- and post- VR intervention. (VAS)
Anxiety pre- and postintervention in the VR intervention group.
Time frame: Day 2-4 on the surgical ward.
Difference in stress scores pre- and post- VR intervention. (VAS)
Stress pre- and postintervention in the VR intervention group.
Time frame: Day 2-4 on the surgical ward.
Difference in depression scores pre- and post- VR intervention. (VAS)
Depression pre- and postintervention in the VR intervention group.
Time frame: Day 2-4 on the surgical ward.
Analgesic use
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, the first four postoperative days on the surgical ward.
Feasibility of VR
Questionnaire, interview
Time frame: Day 1-4 postoperative
Patients acceptability
Questionnaire, interview
Time frame: Day 1-4 postoperative
Tolerability of Virtual Reality
Questionnaire, interview
Time frame: Day 1-4 postoperative
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center