The aim of the study is to measure the effect on pain during needle-related procedures using VR hypnosis glasses versus hypnosis by a health care professional. Secondarily, anxiety, blood pressure, heart rate and patient satisfaction are measured.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychologische ondersteuning
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the difference in pain score between both
groups, measured using the Wong-Baker FACES scale.
Secondary outcome
Pain by health care provider
Fear by patient
Anxiety by health care provider
Blood pressure
Heart rate
Background summary
Research shows that children experience the venipuncture as the most
frightening act in the hospital. Hypnosis has been shown to be an effective
means of reducing anxiety, pain and stress in children during needle-related
procedures. Because little research has been done into the effect of hypnosis
using Virtual Reality (VR) glasses in children, but it has already been shown
to be effective in adults, this study looks at the effects on pain and anxiety
in children.
Study objective
The aim of the study is to measure the effect on pain during needle-related
procedures using VR hypnosis glasses versus hypnosis by a health care
professional. Secondarily, anxiety, blood pressure, heart rate and patient
satisfaction are measured.
Study design
The study is a non-blinded, mono-center, non-inferiority Randomized Controlled
Trial (RCT).
Study burden and risks
Participants may experience dizziness or nausea related to VR when
participating in this study. Patients at higher risk for these side effects are
not included in the study in order to minimize the risk of these side effects.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
- Age 6 to 18 years
- Undergoing a needle-related procedure (IV insertion, venipuncture, injection
and lumbar puncture)
Exclusion criteria
- Mental retardation
- Autistic spectrum disorder
- Epilepsy
- Visual impairment
-Hearing impairment
- Insufficient command of the Dutch language
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 | NL76118.100.20 |
| OMON | NL-OMON23283 |