Virtual Reality for the Treatment of Pain in Pediatric Vaccination
Condition: Virtual Reality; Vaccination; Pain; Nursing
Study type: Interventional

Summary: 
      Objective: to estimate the effect of virtual reality as a distracting technique against
      traditional distracting techniques in the vaccination procedure in the pediatric population.

      Design: randomized clinical trial. Field of study: the study will be carried out in the field
      of pediatric primary care nursing consultation, where the pediatric systematic vaccination is
      performed.

      Subjects to study: the sample will be made up of children from 3 to 14 years old who are
      punctured for immunization in the Fuensanta Health Center that belongs to the Department of
      Health Valencia-General Hospital.

      Variables: age, sex, family country of origin, years living in Spain, number of children of
      the nuclear family, order in the number of siblings, socioeconomic level, age of the
      caregiver that accompanies the child, affiliation / bond with the child . Group to which the
      subject belongs (intervention group vs. control group). Number of punctures received in the
      last year. Heart rate pre and post vaccination. Type of vaccine. Combination of several
      punctures in the query. Previous use of virtual reality. Level of pain and fear after
      puncture. Parent or legal guardian satisfaction.

      Data collection: it will be held at the Health Center on the same day as the vaccination
      prodecure. On the part of the nurse (heart rate, type of vaccine, combination of several
      punctures), the child (pain, fear) and the parents / legal guardian (satisfaction,
      sociodemographic).

      Data analysis: The descriptive analysis of the quantitative variables will be carried out
      through the calculation of means, typical deviations, medians, ranges, minimum and maximum
      values. Qualitative variables will be analyzed in absolute and relative frequencies. For the
      statistical inference analysis, the T-test analysis of mean difference or U-Mann Whitney
      (according to normal compliance) will be used. All analyzes will be performed with a 95%
      confidence interval.
    

Detailed description: 
      Process:

      The health professional responsible for carrying out the intervention will be the nurse of
      the pediatric consultation of the Health Center where the study will be carried out. She is
      the only nurse in this center, so she will be the only professional to perform the procedure
      on all subjects participating in the study; in this way the variability in the puncture
      technique is avoided.

      The nurse will recruit potential participants who meet inclusion criteria, informing about
      the research and answering their possible questions. Once participants wishing to be part of
      the study have signed the informed consent, they will be coded by numbers. These numerical
      codes will be linked chronologically to the random sequence previously generated by the
      sealedenvelopeTM software. Once the nurse knows the group to which the participant belongs,
      she will perform the corresponding intervention.

      The evaluation after the completion of the vaccination procedure will be carried out through
      self-administered scales (by the child for pain and fear variables, and by the caregiver for
      sociodemographic and satisfaction variables). In addition, the nurse will record data
      regarding vaccinations.

      The data collection time is estimated at 1 year and a half or until the sample size is
      reached.

      Intervention:

      The study groups will be determined by the randomization of the sample into two groups: GI
      and GC. The GI will use as a distracting measure the viewing of VR experiences adapted to
      their age with the Oculus Go VR glasses during the puncture. The GC will use habitual
      non-virtual distracting measures: being in the arms of the main caregiver or maintaining
      physical contact with him (for example, shaking hands) and / or playing or watching videos
      with the mobile phone of the parents or legal guardian.
    

Intervention name(s): Virtual Reality Group
Intervention type(s): Other
Intervention description(s): Participants are from 3 to 14 years old who attend a pediatric primarey health care of the Fuensanta Health Center (Valencia) for immunization by vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment