Virtual Reality for the Treatment of Pain in Pediatric Vaccination

NCT04096833 | Completed

• 1 other identifier: CardenalHU_Nursing
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Compare the perception of pain in children during the vaccination between participants to recive virtual reality and to recive usual distraction mesures: Wong-Baker FACES scale

  El dolor es una experiencia emocional y sensorial desagradable, que puede deberse a un procedimiento terapéutico como la vacunación. Para medir el nivel de dolor del niño después de la vacunación, se utilizará la Escala de calificación del dolor: escala FACES de Wong-Baker. Es un cuestionario validado desarrollado por Bieri en 1990. Está indicado para niños entre 3 y 18 años. La escala va de 0 a 10 y tiene 6 caras. A cada cara se le asigna un puntaje. El primero, con un valor de 0, equivale a "no hurt"; la segunda, con un valor de 2 , equivale a "hurts little bit", el tercero, con un valor de 4 es igual a "hurts little more", el cuarto, con un valor de 6, significa "hurts even more", el quinto, con un valor de 8, es igual a "hurts whole lot" y el último, con un valor de 10 es igual a "hurts worse". Se le pide al paciente que seleccione la cara que mejor describa cómo se siente. En el nivel psicométrico, esta escala se valida r = .90, alfa de Cronbach = .93 (Keck, 1996).

  It is immediately after vaccination.

Secondary Outcomes (1)

• Compare the perception of fear in children during the vaccination between participants to recive virtual reality and usual distraction mesures.

  It is immediately after vaccination.

Other Outcomes (1)

• Compare the satisfaction of caregiver (mothers, fathers and legal guardians) satisfaction during the vaccination between participants: questionnaire

  It is immediately after vaccination.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants use as a distracting measure Virtual Reality glasses during the vaccination.

Other: Virtual Reality Group

Control Group

NO INTERVENTION

Participants use usual non-virtual distracting measures during the vaccination.

Interventions

Virtual Reality Group OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 3 and 14 years old, who attend a pediatric nursing office of the Fuensanta Health Center (Valencia) for immunization by vaccine.
• Children who are accompanied by a caregiver (father, mother, legal guardian) during the procedure.
• That both the child and the caregiver understand and speak Spanish.
• That they have consented to participate in the study: in children by verbal consent and in their father, mother, legal guardian, by signing the informed consent document.

You may not qualify if:

• Children with sensory problems that prevent the use of RV.
• Children with sensory impairment of pain perception (for example, spina bifida).
• Children who have taken analgesic medication on the day of the puncture, either orally or topically in the puncture area.
• Children with a history of seizures or dizziness.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad CEU-Cardenal Herrera

Valencia, 46115, Spain

Location

Related Publications (3)

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

  PMID: 21806301 BACKGROUND

• Keck JF, Gerkensmeyer JE, Joyce BA, Schade JG. Reliability and validity of the Faces and Word Descriptor Scales to measure procedural pain. J Pediatr Nurs. 1996 Dec;11(6):368-74. doi: 10.1016/S0882-5963(96)80081-9.

  PMID: 8991337 BACKGROUND

• Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.

  PMID: 29053848 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the care giver (nurse) will know the assignment of participants to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: March 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)