Clinical trial NCT03933124: The Effect of Virtual Reality on Post-surgical Pain and Recovery.
Official title: The Effect of Virtual Reality on Post-surgical Pain and Recovery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Post-surgical Pain
Pain Management
Keywords: Post-surgical pain
Virtual Reality
Distraction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An explorative study using a randomized controlled parallel design.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Daily pain score (VAS, visual analogue scale)
timeFrame: day 1-4, the first four postoperative days on the surgical ward
Secondary outcomes:
measure: Time to 30% pain reduction compared to pain scores on postoperative day 1.
timeFrame: day 1-4, the first four postoperative days on the surgical ward.
measure: Mean Daily worst pain score (VAS)
timeFrame: day 1-4, the first four postoperative days on the surgical ward.
measure: Effect of pain on mobility (NRS, Numeric Rating Scale)
timeFrame: day 1-4, the first four postoperative days on the surgical ward.
measure: Difference in pain scores pre- and post- VR intervention (VAS)
timeFrame: Day 2-4 on the surgical ward.
measure: Quality of recovery -15 questionnaire.
timeFrame: day 1-4, the first four postoperative days on the surgical ward.
measure: Mean Daily Anxiety score (VAS).
timeFrame: day 1-4, the first four postoperative days on the surgical ward.
measure: Mean Daily Stress score (VAS)
timeFrame: day 1-4, the first four postoperative days on the surgical ward.
measure: State-Trait Anxiety Inventory (STAI)-6 questionnaire.
timeFrame: day 1-4, the first four postoperative days on the surgical ward.
measure: Difference in anxiety scores pre- and post- VR intervention. (VAS)
timeFrame: Day 2-4 on the surgical ward.
measure: Difference in stress scores pre- and post- VR intervention. (VAS)
timeFrame: Day 2-4 on the surgical ward.
measure: Difference in depression scores pre- and post- VR intervention. (VAS)
timeFrame: Day 2-4 on the surgical ward.
measure: Analgesic use
timeFrame: day 1-4, the first four postoperative days on the surgical ward.
measure: Feasibility of VR
timeFrame: Day 1-4 postoperative
measure: Patients acceptability
timeFrame: Day 1-4 postoperative
measure: Tolerability of Virtual Reality
timeFrame: Day 1-4 postoperative
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
affiliation: Radboud University Medical Center
name: Harry van Goor, MD,PhD,FRCS
role: PRINCIPAL_INVESTIGATOR
References: