The primary objective is investigating the influence of Virtual Reality distraction on pain. The secondary objectives were, investigating if (1) the executive functions and catastrophizing thoughts influence the effect of VR as pain relief; (2) the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
experimentele pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameters are (1) the distraction technique is significantly
associated with the VAS pain score and (2) the distraction technique is
significantly associated with the tolerance time.
Secondary outcome
The secondary parameters were (3) the executives functions and catastrophizing
thoughts (continue variables) have a moderating role in the expected relation
of the distraction technique and VAS pain scores; (4) the VAS-score for
presence predicts the VAS-score for pain; (5) the VAS-score for presence
predicts the tolerance time; (6) the executive functions (continue variable)
predict the degree of presence in the virtual world (continue variable); (7)
the distraction technique (categorical variable) predicts the degree of
presence (continue variable).
Background summary
Virtual Reality is promising as pain relief and considered as distraction
technique. The extent to which VR is effective in relieving pain depends on the
extent of presence in the virtual world. This study investigates if the quality
of the different executive functions (inhibition, divided attention and working
memory) and the degree of catastrophizing influences the presence in the
virtual world and herewith the effect on pain. This question is also included
in our current study to VR as pain relief during colonoscopies (RTPO-53709).
Study objective
The primary objective is investigating the influence of Virtual Reality
distraction on pain.
The secondary objectives were, investigating if (1) the executive functions and
catastrophizing thoughts influence the effect of VR as pain relief; (2) the
degree of presence in the virtual world influences the effect of VR as pain
relief; (3) the executive functions are associated with the presence in the
virtual world; (4) the degree of presence in the virtual world is greater
during playing a game than watching a video.
Study design
This concerns a randomized study with stratification for age. There are two age
groups (<50 jaar en >=50 jaar) with three research groups each: 1) VR game, 2)
VR video and personal associations. In total 78 (2x(3*13) subjects are needed.
The duration of this study is from the first of March 2016 until the first of
March 2017.
Intervention
Group 1 is undergoing the cold pressor task with VR game, group 2 with VR
video, group 3 without VR glasses and with the task to think about something
distracting. Preliminary, all subjects carry out four executive tasks and fill
in one questionnaire.
Study burden and risks
This study attemts to clarify the efficacy of VR as pain relief. A few studies
describe nausea as possible side effect of the use of VR. Subjects 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
Healthy adults between 18 and 75 years old.
Exclusion criteria
- Limited vision or hearing
- Limited communication skills
- Acute or chronic pain
- Phenomenon of Raynaud
- Cardiovascular disorders
- Hypertension
- Endocrine, metabolic, neurologic disorders
- Musculoskeletal disorders like rheumatism or muscular disorders
- epilepsy
- psychiatric diagnoses, like depression or anxiety
- current injuries to the hands
- use of medication
- pregnancy
- use of alcohol or drugs 24 hours before the start of participation
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 | NL56224.099.15 |
| OMON | NL-OMON20465 |