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

Primary Purpose

Pain, Post-surgical Pain, Pain Management

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Post-surgical pain, Virtual Reality, Distraction

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Intervention group

Control group

Arm Description

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.

The control group receives standard postoperative care.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.
Mean Daily worst pain score (VAS)
Worst pain in the last 24h.
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".
Difference in pain scores pre- and post- VR intervention (VAS)
Pain pre- and postintervention in the VR intervention group.
Quality of recovery -15 questionnaire.
Quality of recovery -15 questionnaire.
Mean Daily Anxiety score (VAS).
Anxiety on average in the last 24h.
Mean Daily Stress score (VAS)
Stress on average in the last 24h.
State-Trait Anxiety Inventory (STAI)-6 questionnaire.
State-Trait Anxiety Inventory (STAI)-6 questionnaire.
Difference in anxiety scores pre- and post- VR intervention. (VAS)
Anxiety pre- and postintervention in the VR intervention group.
Difference in stress scores pre- and post- VR intervention. (VAS)
Stress pre- and postintervention in the VR intervention group.
Difference in depression scores pre- and post- VR intervention. (VAS)
Depression pre- and postintervention in the VR intervention group.
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).
Feasibility of VR
Questionnaire, interview
Patients acceptability
Questionnaire, interview
Tolerability of Virtual Reality
Questionnaire, interview

Full Information

First Posted
April 29, 2019
Last Updated
September 15, 2021
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03933124
Brief Title
The Effect of Virtual Reality on Post-surgical Pain and Recovery.
Acronym
VIRTUAL
Official Title
The Effect of Virtual Reality on Post-surgical Pain and Recovery.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post-surgical Pain, Pain Management
Keywords
Post-surgical pain, Virtual Reality, Distraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An explorative study using a randomized controlled parallel design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group receives standard postoperative care.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
Relaxmaker, Oculus Go, CareVRx
Intervention Description
The Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4.
Primary Outcome Measure Information:
Title
Mean Daily pain score (VAS, visual analogue scale)
Description
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".
Time Frame
day 1-4, the first four postoperative days on the surgical ward
Secondary Outcome Measure Information:
Title
Time to 30% pain reduction compared to pain scores on postoperative day 1.
Description
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.
Title
Mean Daily worst pain score (VAS)
Description
Worst pain in the last 24h.
Time Frame
day 1-4, the first four postoperative days on the surgical ward.
Title
Effect of pain on mobility (NRS, Numeric Rating Scale)
Description
NRS score (Numeric Rating Scale): 0-10. 0 is defined as "no pain at all", 10 is "the worst pain the patient can imagine".
Time Frame
day 1-4, the first four postoperative days on the surgical ward.
Title
Difference in pain scores pre- and post- VR intervention (VAS)
Description
Pain pre- and postintervention in the VR intervention group.
Time Frame
Day 2-4 on the surgical ward.
Title
Quality of recovery -15 questionnaire.
Description
Quality of recovery -15 questionnaire.
Time Frame
day 1-4, the first four postoperative days on the surgical ward.
Title
Mean Daily Anxiety score (VAS).
Description
Anxiety on average in the last 24h.
Time Frame
day 1-4, the first four postoperative days on the surgical ward.
Title
Mean Daily Stress score (VAS)
Description
Stress on average in the last 24h.
Time Frame
day 1-4, the first four postoperative days on the surgical ward.
Title
State-Trait Anxiety Inventory (STAI)-6 questionnaire.
Description
State-Trait Anxiety Inventory (STAI)-6 questionnaire.
Time Frame
day 1-4, the first four postoperative days on the surgical ward.
Title
Difference in anxiety scores pre- and post- VR intervention. (VAS)
Description
Anxiety pre- and postintervention in the VR intervention group.
Time Frame
Day 2-4 on the surgical ward.
Title
Difference in stress scores pre- and post- VR intervention. (VAS)
Description
Stress pre- and postintervention in the VR intervention group.
Time Frame
Day 2-4 on the surgical ward.
Title
Difference in depression scores pre- and post- VR intervention. (VAS)
Description
Depression pre- and postintervention in the VR intervention group.
Time Frame
Day 2-4 on the surgical ward.
Title
Analgesic use
Description
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).
Time Frame
day 1-4, the first four postoperative days on the surgical ward.
Title
Feasibility of VR
Description
Questionnaire, interview
Time Frame
Day 1-4 postoperative
Title
Patients acceptability
Description
Questionnaire, interview
Time Frame
Day 1-4 postoperative
Title
Tolerability of Virtual Reality
Description
Questionnaire, interview
Time Frame
Day 1-4 postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry van Goor, MD,PhD,FRCS
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud university medical center
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

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

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