The Effect of Virtual Reality on Post-surgical Pain and Recovery. (VIRTUAL)

• ClinicalTrials.gov Identifier: NCT03933124
• Recruitment Status: Completed
• First Posted: May 1, 2019
• Last Update Posted: September 16, 2021
• Sponsor: Radboud University Medical Center
• Information provided by (Responsible Party): Radboud University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain; Post-surgical Pain; Pain Management	Device: Virtual Reality	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: An explorative study using a randomized controlled parallel design.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Virtual Reality on Post-surgical Pain and Recovery.
• Actual Study Start Date: May 21, 2019
• Actual Primary Completion Date: February 11, 2021
• Actual Study Completion Date: February 11, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Virtual Reality Intervention group; 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 Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4.; Other Names: Relaxmaker; Oculus Go; CareVRx
No Intervention: Control group; The control group receives standard postoperative care.

Outcome Measures

Primary Outcome Measures :

1. Mean Daily pain score (VAS, visual analogue scale) [ 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".

Secondary Outcome Measures :

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. ]
   Time to 30% pain reduction compared to pain scores on postoperative day 1.
2. Mean Daily worst pain score (VAS) [ Time Frame: day 1-4, the first four postoperative days on the surgical ward. ]
   Worst pain in the last 24h.
3. Effect of pain on mobility (NRS, Numeric Rating Scale) [ 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".
4. Difference in pain scores pre- and post- VR intervention (VAS) [ Time Frame: Day 2-4 on the surgical ward. ]
   Pain pre- and postintervention in the VR intervention group.
5. Quality of recovery -15 questionnaire. [ Time Frame: day 1-4, the first four postoperative days on the surgical ward. ]
   Quality of recovery -15 questionnaire.
6. Mean Daily Anxiety score (VAS). [ Time Frame: day 1-4, the first four postoperative days on the surgical ward. ]
   Anxiety on average in the last 24h.
7. Mean Daily Stress score (VAS) [ Time Frame: day 1-4, the first four postoperative days on the surgical ward. ]
   Stress on average in the last 24h.
8. State-Trait Anxiety Inventory (STAI)-6 questionnaire. [ Time Frame: day 1-4, the first four postoperative days on the surgical ward. ]
   State-Trait Anxiety Inventory (STAI)-6 questionnaire.
9. Difference in anxiety scores pre- and post- VR intervention. (VAS) [ Time Frame: Day 2-4 on the surgical ward. ]
   Anxiety pre- and postintervention in the VR intervention group.
10. Difference in stress scores pre- and post- VR intervention. (VAS) [ Time Frame: Day 2-4 on the surgical ward. ]
    Stress pre- and postintervention in the VR intervention group.
11. Difference in depression scores pre- and post- VR intervention. (VAS) [ Time Frame: Day 2-4 on the surgical ward. ]
    Depression pre- and postintervention in the VR intervention group.
12. Analgesic use [ 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).
13. Feasibility of VR [ Time Frame: Day 1-4 postoperative ]
    Questionnaire, interview
14. Patients acceptability [ Time Frame: Day 1-4 postoperative ]
    Questionnaire, interview
15. Tolerability of Virtual Reality [ Time Frame: Day 1-4 postoperative ]
    Questionnaire, interview

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Netherlands

Radboud university medical center

Nijmegen, Netherlands

Sponsors and Collaborators

Radboud University Medical Center

Investigators

• Principal Investigator: Harry van Goor, MD,PhD,FRCS; Radboud University Medical Center

More Information

• Responsible Party: Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT03933124
• Other Study ID Numbers: NL69077.091.19
• First Posted: May 1, 2019
• Last Update Posted: September 16, 2021
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Radboud University Medical Center:

Post-surgical pain; Virtual Reality; Distraction

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations