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

NCT03933124 | Completed

• 1 other identifier: NL69077.091.19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Post-surgical Pain; Pain Management

Keywords

Post-surgical pain; Virtual Reality; Distraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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)

  day 1-4, the first four postoperative days on the surgical ward.

• Effect of pain on mobility (NRS, Numeric Rating Scale)

  day 1-4, the first four postoperative days on the surgical ward.

• Difference in pain scores pre- and post- VR intervention (VAS)

  Day 2-4 on the surgical ward.

• Quality of recovery -15 questionnaire.

  day 1-4, the first four postoperative days on the surgical ward.

Study Arms (2)

Virtual Reality Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group receives standard postoperative care.

Interventions

Virtual Reality DEVICE

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

Also known as: Relaxmaker, Oculus Go, CareVRx

Virtual Reality Intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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'.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Harry van Goor, MD,PhD,FRCS

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An explorative study using a randomized controlled parallel design.

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: May 21, 2019
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: September 16, 2021

Record last verified: 2020-10

Locations

NL (1)