Pain Clinical Trial
Official title:
The Effect of Virtual Reality Versus Standard-of-care Treatment on Pain Perception During Paediatric Vaccination: Study Protocol for a Randomised Controlled Trial.
Verified date | February 2024 |
Source | Cardenal Herrera University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 162 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 14 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad CEU-Cardenal Herrera | Valencia |
Lead Sponsor | Collaborator |
---|---|
Cardenal Herrera University |
Spain,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Compare the satisfaction of caregiver (mothers, fathers and legal guardians) satisfaction during the vaccination between participants: questionnaire | Caregivers (mothers, fathers and legal guardians) will complete a satisfaction questionnaire prepared by Gold and Mahrer (2018) to assess satisfaction with the vaccination procedure and with the distraction measures used (RV or habitual distraction measures). This questionnaire has 11 items, 9 of them with a Likert scale ranging from 1 to 10. 1 equals "not at all", "not at all well" or "nothing more". 5 equals "somewhat", moderately well "," moderatly "or" some things more. "10 equals" definitely "," extremely well "," extremely "or" a lot more. "The first and last question of the questionnaire are open questions and the sixth question is a docotomic answer: yes / no This tool is not validated. | It is immediately after vaccination. | |
Primary | 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 | Compare the perception of fear in children during the vaccination between participants to recive virtual reality and usual distraction mesures. | Vaccination causes fear in children. To assess the fear perceived by the child, the Child Fear Scale (CFS) will be used (McMurtry, Noel, Chambers, McGrath, 2011). CFS consists of five faces that show different levels of fear: the first face, no. 0, the second, no. 1, the third, no. 2, the fourth, no. 3, and the last, no. 4. The first face equals "no fear" and the last "maximum fear possible". The CFS is an effective instrument for measuring fear related to pain during vaccination of children. This tool is validated (Interrater Time 1 reliability: rs = .51, p <.001 and test-retest reliability rs = .76, p <.001). | It is immediately after vaccination. |
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