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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Pain Management; Post-surgical Pain
• Intervention / Treatment: Device: Virtual Reality

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Oculus Go; Relaxmaker; CareVRx
NO_INTERVENTION: Control group; The control group receives standard postoperative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2019
• Primary Completion (ACTUAL): February 11, 2021
• Study Completion (ACTUAL): February 11, 2021

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (ACTUAL): May 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Virtual Reality; Distraction; Post-surgical pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: NL69077.091.19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No