Virtual reality hypnosis is similarly effective in comparison to conventional medical hypnosis in reduction of pain and anxiety throughout needle related procedures in children in a clinical setting.
ID
Source
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Health condition
Research involving
Sponsors and support
Intervention
- Psychosocial intervention
Outcome measures
Primary outcome
Patient-perceived pain before and after the procedure.
Secondary outcome
Anxiety scored before and after the procedure by child and health care worker. Pulse rate and blood pressure will be measured. Also, patient satisfaction, and possible adverse events nausea and dizziness will be recorded.
Background summary
Anxiety causes the brain to be more perceptive to painful stimuli, which can create an upward spiral of distress. Needle-related procedures are the most important cause of pain, anxiety and stress among children in a clinical setting. Research in children subjected to repetitive negative experiences, showed a slower post-surgical recovery and a persistent lower pain threshold. There is a growing body of evidence indicating that procedural distress is associated with various complications such as impaired wound healing. Therefore, it is hypothesized that by enhancing procedural comfort, the overall outcome can be improved. Non-pharmacological interventions are proven to be effective in reducing procedural distress. This includes distraction, breathing exercises, language-based “neutral signaling” and, most comprehensively, medical hypnosis. However, medical hypnosis is time-consuming and costly, which may pose a barrier to general implementation in a clinical setting. Recently, virtual reality (VR) has emerged as a new non-pharmacological treatment modality, which shows promising results in children undergoing medical procedures. Our aim is to compare VR hypnosis with conventional medical hypnosis by a health care worker in children undergoing needle-related procedures. This randomized controlled trial will assess the effect of VR hypnosis versus conventional medical hypnosis on pain and anxiety in children undergoing a needle-related procedure in a non-inferiority design.
Study objective
Virtual reality hypnosis is similarly effective in comparison to conventional medical hypnosis in reduction of pain and anxiety throughout needle related procedures in children in a clinical setting.
Study design
Intervention
Virtual reality hypnosis, medical hypnosis.
Age
Inclusion criteria
- Age between 6 and 18 years - Required needle related procedure (e.g. intravenous cannula insertion, venipuncture, injection and lumbar puncture)
Exclusion criteria
- - mental retardation
- - autism spectrum disorder
- - epileptic disorder
- - uncorrected visual and/or auditory impairment.
- - children with extreme needle phobia and/or fear
Design
Recruitment
IPD sharing statement
Plan description
Postbus 2500
3430 EM Nieuwegein
088 320 8784
info@mec-u.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9385 |
| CCMO | NL76118.100.20 |
| OMON | NL-OMON51145 |