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

Pain Clinical Trial

— VIRTUAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933124
• Other study ID #: NL69077.091.19
• Status: Completed
• Phase: N/A
• Start date: May 21, 2019
• Est. completion date: February 11, 2021

Study information

• Verified date: October 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 11, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Pain Management
• Pain, Postoperative
• Post-surgical Pain

Intervention

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

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Mean Daily worst pain score (VAS)	Worst pain in the last 24h.	day 1-4, the first four postoperative days on the surgical ward.
Secondary	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.
Secondary	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.
Secondary	Quality of recovery -15 questionnaire.	Quality of recovery -15 questionnaire.	day 1-4, the first four postoperative days on the surgical ward.
Secondary	Mean Daily Anxiety score (VAS).	Anxiety on average in the last 24h.	day 1-4, the first four postoperative days on the surgical ward.
Secondary	Mean Daily Stress score (VAS)	Stress on average in the last 24h.	day 1-4, the first four postoperative days on the surgical ward.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Feasibility of VR	Questionnaire, interview	Day 1-4 postoperative
Secondary	Patients acceptability	Questionnaire, interview	Day 1-4 postoperative
Secondary	Tolerability of Virtual Reality	Questionnaire, interview	Day 1-4 postoperative