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Virtual Reality for the Treatment of Pain in Pediatric Vaccination

NCT04096833 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2024-02-07

No results posted yet for this study

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.

Conditions

  • Virtual Reality
  • Vaccination
  • Pain
  • Nursing

Interventions

OTHER

Virtual Reality Group

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.

Sponsors & Collaborators

  • Cardenal Herrera University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04096833 on ClinicalTrials.gov