Pain Clinical Trial
— VIRTUALOfficial title:
The Effect of Virtual Reality on Post-surgical Pain and Recovery.
Verified date | October 2020 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | February 11, 2021 |
Est. primary completion date | February 11, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Patient underwent surgery - Patient reports a postoperative pain score =4 on the first postoperative day at the surgical ward and pain score should also be marked with 'pain is not acceptable'. - At the day of recruitment, the estimated length of stay is at least 4 days after inclusion. - Patient is willing and able to comply with the trial protocol. - Patient is at least 16 years old on the day the informed consent form will be signed. Exclusion Criteria: - Patient suffers from delirium or acute confusional state. - Patient has (a history of) dementia, seizure or epilepsy. - Patient with severe hearing/visual impairment not corrected. - Patient is placed in isolation. - The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema). - Unplanned (re)admission to the intensive care unit (ICU). - Inclusion in another trial to evaluate new ways of treating pain |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud university medical center | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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. | |
Secondary | Mean Daily worst pain score (VAS) | Worst pain in the last 24h. | day 1-4, the first four postoperative days on the surgical ward. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | Quality of recovery -15 questionnaire. | Quality of recovery -15 questionnaire. | day 1-4, the first four postoperative days on the surgical ward. | |
Secondary | Mean Daily Anxiety score (VAS). | Anxiety on average in the last 24h. | day 1-4, the first four postoperative days on the surgical ward. | |
Secondary | Mean Daily Stress score (VAS) | Stress on average in the last 24h. | day 1-4, the first four postoperative days on the surgical ward. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | Feasibility of VR | Questionnaire, interview | Day 1-4 postoperative | |
Secondary | Patients acceptability | Questionnaire, interview | Day 1-4 postoperative | |
Secondary | Tolerability of Virtual Reality | Questionnaire, interview | Day 1-4 postoperative |
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