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

NCT ID: NCT03933124

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-21
• Study Completion Date: 2021-02-11

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.

Conditions

Pain; Post-surgical Pain; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

The Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4.

Control group

The control group receives standard postoperative care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

The Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4.

Intervention Type: DEVICE

Other Intervention Names

Relaxmaker; Oculus Go; CareVRx

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry van Goor, MD,PhD,FRCS

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud university medical center

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

NL69077.091.19

Identifier Type: -

Identifier Source: org_study_id