The Effect of Virtual Reality Versus Standard-of-care Treatment on Pain Perception During Paediatric Vaccination: Study Protocol for a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the care giver (nurse) will know the assignment of participants to the treatment groups.
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group
Participants use as a distracting measure Virtual Reality glasses during the vaccination.
干预措施: Virtual Reality Group (Other)
Control Group
Participants use usual non-virtual distracting measures during the vaccination.
结局指标
主要结局
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
时间窗: It is immediately after vaccination.
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).
次要结局
- 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.)
研究者
Laura García Garcés
Principal Investigator
Cardenal Herrera University