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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Intervention group | Experimental | 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.
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| Control group | No Intervention | The control group receives standard postoperative care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | The Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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". | day 1-4, the first four postoperative days on the surgical ward |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 1-4, the first four postoperative days on the surgical ward. |
| Mean Daily worst pain score (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry van Goor, MD,PhD,FRCS | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud university medical center | Nijmegen | Netherlands |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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An explorative study using a randomized controlled parallel design.
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|
Worst pain in the last 24h. |
| 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". | 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. | Day 2-4 on the surgical ward. |
| Quality of recovery -15 questionnaire. | Quality of recovery -15 questionnaire. | day 1-4, the first four postoperative days on the surgical ward. |
| Mean Daily Anxiety score (VAS). | Anxiety on average in the last 24h. | day 1-4, the first four postoperative days on the surgical ward. |
| Mean Daily Stress score (VAS) | Stress on average in the last 24h. | 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. | 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. | 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. | 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. | 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). | day 1-4, the first four postoperative days on the surgical ward. |
| Feasibility of VR | Questionnaire, interview | Day 1-4 postoperative |
| Patients acceptability | Questionnaire, interview | Day 1-4 postoperative |
| Tolerability of Virtual Reality | Questionnaire, interview | Day 1-4 postoperative |
| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |