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

Not Applicable

Completed

• Conditions: Pain; Post-surgical Pain; Pain Management
• Interventions: Device: Virtual Reality

• Registration Number: NCT03933124
• Lead Sponsor: Radboud University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-01
• Study Start: 2019-05-21
• Status Verified: 2020-10
• Primary Completion: 2021-02-11
• Study Completion: 2021-02-11
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Intervention group	Virtual Reality	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.

Primary Outcome Measures

Name	Time	Method
Mean Daily pain score (VAS, visual analogue scale)	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

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

Trial Locations

Locations (1)

Radboud university medical center; 🇳🇱 Nijmegen, Netherlands