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The effect of Virtual Reality on post-surgical pain and recovery

The effect of Virtual Reality on post-surgical pain and recovery - VIRTUAL study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49167
Enrollment
100
Registered
2019-04-18
Start date
2019-05-21
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pijn, nociceptie. pain

Interventions

Participants will be randomly assigned to either the control group or one of the intervention groups. The intervention includes an add-on VR intervention with three types of HMDs: one with 2D videos

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patient underwent elective surgery. 2. Patient reports a postoperative pain score *4 on the first postoperative day at the surgical ward. Pain scores will be derived from EPIC en should also be marked with *pain is not acceptable*. 3. At the day of recruitment, the estimated length of stay is at least 4 days after inclusion. 4. Patient is willing and able to comply with the trial protocol. 5. Patient is at least 16 years old on the day the informed consent form will be signed.

Exclusion criteria

Exclusion criteria: 1. Patient suffers from delirium or acute confusional state. 2. Patient has (a history of) dementia, seizure, or epilepsy. 3. Patient with severe hearing/visual impairment not corrected. 4. Patient is placed in isolation. 5. The skin of the patient*s head or face is not intact (for example head wounds, psoriasis, eczema). 6. Unplanned (re)admission to the intensive care unit (ICU). 7. Inclusion in another trial to evaluate new ways of treating pain

Design outcomes

Primary

MeasureTime frame
Mean Daily VAS Pain score (average pain in the last 24h) on postoperative day 1-4

Secondary

MeasureTime frame
Mean Daily worst VAS Pain score, Effect of pain on mobility, breathing and sleep (NRS scores 0-10), Difference in pain scores pre- and post- VR intervention in the intervention group. Quality of recovery (questionnaire), anxiety scores, stress scores and analgesic use. Individual and pain-related characteristics, previous experience with digital technologies. Barriers and facilitators to use VR treatment, number and duration of VR interventions, patients* opinions on VR, adverse events, reasons to withdraw.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)