Pain, Procedural, Pediatric ALL, Virtual Reality
Conditions
Brief summary
The goal of this clinical trial is to test if the use of virtual reality glasses reduces the pain and anxiety that children feel when they perform a blood test. Children between 7 and 12 years old from 5 health centers and 2 hospitals will participate, and the children will be divided into two groups. In the control group, the analysis will be done in the usual way (for example, distracting with questions) and in the intervention group, the analysis will be done while the children use virtual reality. The satisfaction of parents and nursing will also be analyzed.
Interventions
BEHAVIORALVirtual reality
In the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture.
Sponsors
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Patients are randomized in a 1:1 ratio to the intervention group (use of virtual reality during blood collection) and the control group (usual care). The randomization sequence is different for each participating center.
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Children between 7 and 12 years old who attend participating centers for scheduled blood tests. * Consent to participate by signing the informed consent.
Exclusion criteria
* Children younger than 7 years old. * Children older than 12 years old. * Children that don't sign the informed consent. * Children with psychomotor and neurocognitive delay. * Children with visual or hearing impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain associated with venipuncture | 1 day: The day of the venipuncture | Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain. |
| Anxiety | 1 day: The day of the venipuncture | Groningen distress scale: From 1 to 5. 1 implies a non-anxious patient and 5 a very anxious patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time required for analysis | 1 day: The day of the venipuncture | Minutes |
| Number of attempts for analytics | 1 day: The day of the venipuncture | 1, 2, 3, 4, or 5 |
| Difficulty level of the technique | 1 day: The day of the venipuncture | Easy, normal or difficult |
| Parents satisfaction | 1 day: The day of the venipuncture | 1 = unsatisfied 10 = very satisfied |
| Nurse anxiety | 1 day: The day of the venipuncture | 1 = totally calm 10 = very anxious |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parental presence at the moment of venipuncture | 1 day: The day of the venipuncture | Yes or not |
| Venipuncture in the last 6 months | Before venipuncture | Venipuncture in the last 6 months |
| Pacient age at the moment of venipuncture | Before venipuncture | In years |
| Pacient sex | Before venipuncture | Male or female |
Countries
Spain
Outcome results
None listed