Primary, this study investigates the effect of VR on procedural pain. Secondary, this study investigates the effect of VR on satisfaction with the procedure, identifies patient-related, burn wound-related and psychology-related variables associated…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Brandwonden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
VR is effective in reducing pain, when there are both statistically and
clinically significant differences between the VAS-scores of overall pain
during care as usual with VR and care as usual. The clinically significant
difference include that the VAS-score of overall pain during care as usual with
VR is *0.9 cm lower than the VAS-score of overall pain during care as usual
Secondary outcome
- The satisfaction with the use of VR is meaningful when the VAS-score of
satisfaction with care as usual with VR is not statistically and clinically
significantly lower than the VAS-score of satisfaction with care as usual. The
clinically significant difference include that the VAS-score of satisfaction
with care as usual with VR is not *0.9 cm lower than the VAS-score of
satisfaction with care as usual.
- The identification of independent variables associated with the expected
statistically and clinically significant differences in pain and satisfaction,
between care as usual with VR and care as usual.
- The number of milligrams sedation and/or analgesics used during care as usual
with VR compared to care as usual.
- The number of minutes of care as usual with VR compared to care as usual.
- The number of patients reporting nausea as a consequence of the use of VR.
- The description of the user friendliness of the VR-equipment with patients
and medical professionals.
Background summary
VR turned out to be promising as adjunct non-pharmacological intervention
during wound dressing changes. Because the evidence for VR as pain relief is
limited, more high-quality studies are needed to investigate the effect of VR
on procedural pain. This study focuses on both the effectiveness and efficacy
of VR, and succeeds previous study in Martini Hospital Burn Centre (METC
2004-42).
Study objective
Primary, this study investigates the effect of VR on procedural pain.
Secondary, this study investigates the effect of VR on satisfaction with the
procedure, identifies patient-related, burn wound-related and
psychology-related variables associated with the effectiveness of VR.
Furthermore, this study focuses on sedation and/or analgesic requirements,
procedure time and nausea as a side-effect. Lastly, this study investigates the
user friendliness of the VR-equipment with both patients and medical
professionals.
Study design
Randomized controlled trial; the admission order determines the allocation to
the treatment or control group. After ten inclusions to one group, the
following ten patients are allocated to the other group. In total, 128 patients
are needed.
Study burden and risks
Using VR during wound dressing changes has several benefits. Patients benefit a
reduction in pain experience, but also reduction in amount of sedation and
therefore reduction in risk on side effects. A few studies describe nausea as
possible side effect of the use of VR. Patients recover directly by putting off
the VR glasses.
Van Swietenplein 1
Groningen 9700RM
NL
Van Swietenplein 1
Groningen 9700RM
NL
Listed location countries
Age
Inclusion criteria
- Age 8 years and older
- Expected admission time for at least 4 days
- Informed consent
- Mentally competent
- Dutch speaking and reading
- Permission of doctor
- Permission of psychiatrist
- Ability to use VR
Exclusion criteria
- Physical impairments (facial burns)
- Need for intensive care / severe comorbidity
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54030.099.15 |
| OMON | NL-OMON29656 |