跳至主要内容
临床试验/NCT05839054
NCT05839054已完成不适用

Evaluation of Virtual Reality Glasses Use During Inhaler Treatment in Children

Haseki Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 135 人开始时间: 2022年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
135
试验地点
2
主要终点
Change in the FLACC (Face, Legs, Activity, Cry and Consolability ) pain scoring system

研究概览

简要总结

Virtual reality (VR) glasses are technological devices that are often used in medical fields recently and are seen as suitable for distracting children. In the last few years, many studies have been conducted to facilitate pediatric patients against painful or frightening medical procedures. For uncomfortable procedures, distracting the child's attention is seen as the most important point. VR technology has been used for procedures such as burn cases, tooth extraction, intramuscular injection, intravenous cannula, lumbar puncture, and the results of the research have been found to be satisfactory. Using VR glasses alone or in combination with standard care is effective in reducing pain and anxiety. So far, there is no study in the literature on distraction with VR during inhaler treatment in pediatric patients. Children cannot receive inhaler treatment efficiently due to reasons such as restlessness, crying, and pulling the mask during inhaler treatment, and their hospital stay is prolonged. In this study, the investigators planned to compare the patients who received inhaler treatment with VR glasses with the patients who received treatment without the aid of any device in terms of treatment compliance.

Thus, the investigators aimed to make the inhaler treatment more comfortable with VR technology.

详细描述

The study was designed by including children aged 2-5 years, who needed inhaler treatment (salbutamol) between 10.11.2022 and 01.04.2023, whose families gave consent for the study. This age group (preschool) was chosen because it is the age group that presents the most difficulties to families and physicians during inhaler treatment and screen exposure does not cause problems up to a certain point. The study was conducted as a prospective, single-blind, randomized, controlled study in the Pediatric Emergency Department of the Health Sciences University Haseki Training and Research Hospital.

Children with neuromotor retardation, visual and auditory problems, underlying chronic diseases (bronchiolitis, chronic lung diseases other than asthma, congenital heart diseases, neurological diseases such as epilepsy), obesity or malnutrition (to equalize the effectiveness of the drug dose), adrenaline, budesonide or Those who receive ipratropium bromide treatment, those who will receive inhaler nebula treatment for the first time, those who have received inhaler treatment in the last 72 hours, those who have a previous operation or sedative history, those who have a fever above 37.5°C, those who have used VR before, those under 2 years of age to avoid screen exposure children (infants) and children over 5 years old (school period) were excluded from the study. In addition, children with a saturation value below 92% at the time of admission, those presenting with severe asthma attacks and those with respiratory failure symptoms were not included in the study. Children with a score of 5 and above according to the bronchiolitis severity score were excluded from the study.

The children included in the study were divided into 3 groups by randomization method: VR audio-visual users (Roller Coasters, group 1), VR audio-visual users (Wild Dolphins, group 2) and those who did not use any additional equipment. (group 3). These children were observed during their 15-minute inhaler treatment and the groups were compared in terms of crying times, changes in RR, SpO2, HR values with pre- and post-treatment physician questionnaires and family questionnaires.

In the comparison study of Gerceker et al., with VR glasses in children from whom blood was drawn, the pain score was found to be 1.2 ± 2.2 in children using VR glasses, and 4.1 ± 3.5 in children without VR (control group), and the standard effect size was determined as 0.99 in the power analysis based on these data. When the number of 45 cases in each group is taken, the power of the study was calculated to be with a 1% margin of error and 98% power.

During the study period (November 2022 - April 2023), 913 children received inhaler treatment in our hospital. Children who met the selection criteria and whose families agreed to participate in the study were included in the study, and the study was terminated when the target number of 135 children was reached. 689 children who did not meet the inclusion criteria (such as chronic disease or severe bronchiolitis) and were not suitable for their age (such as under 2 years old, over 5 years old) were excluded from the study. Of the 224 children who met the inclusion criteria, 89 were excluded because they refused to participate in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Children were identified by a single investigator. He referred the child to the other investigator by noting the FLACC and MYPAS score, as well as the RR, SpO2, and HR values, which he determined to establish his criteria, including the first investigator. The second investigator divided the child into groups using the randomization method, with the double chronometer during the treatment, the duration of the crying and the effective treatment time were desired. He was re-directed to the first investigator, not telling the first investigator to group the treatment ending families and groups. Thus, before and after the first investigator's examination, when filling in the FLACC and MYPAS score and determining SpO2, RR and HR, the groups did not know which group they belonged to.

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between 2-5 years old
  • Children who need inhaler treatment (salbutamol)
  • Children whose families give consent to participants the study

排除标准

  • Children with neuromotor retardation,
  • Visual and auditory problems,
  • Underlying chronic diseases (bronchiolitis, chronic lung diseases other than asthma, congenital heart diseases, neurological diseases such as epilepsy),
  • Obesity or malnutrition (to equalize the effectiveness of the drug dose),
  • Adrenaline, budesonide or those who receive ipratropium bromide treatment,
  • Those who will receive inhaler inhaler treatment for the first time,
  • Those who have received inhaler treatment in the last 72 hours,
  • Those who have a previous operation or sedative history,
  • Those who have a fever above 37.5°C,
  • Those who have used VR before,
  • Patients with a saturation value below 92% at the time of admission,
  • Those presenting with severe asthma attack,
  • Those with respiratory failure symptoms,
  • Patients with a score of 5 and above according to the bronchiolitis severity score
  • Those under 2 years of age to avoid screen exposure patients (infants) and patients over 5 years old (school period)

研究组 & 干预措施

Roller Coasters, group 1

Experimental

VR audio-visual users with Roller Coasters

干预措施: Virtual Reality audio and visual glass (Roller Coasters, group 1) (Device)

Wild Dolphins, group 2

Experimental

VR audio-visual users with Wild Dolphins

干预措施: Virtual Reality audio and visual glass (Wild Dolphins, group 2) (Device)

group 3

No Intervention

did not use any additional equipment

结局指标

主要结局

Change in the FLACC (Face, Legs, Activity, Cry and Consolability ) pain scoring system

时间窗: Baseline

Changing pain scores by helping with uncomfortable procedures for children. The researchers used the FLACC (Face, Legs, Activity, Cry and Consolability ) scoring and scored between 0 and 10. A higher score indicated more pain and restlessness.

次要结局

未报告次要终点

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berker Okay

Principal Investigator

Haseki Training and Research Hospital

研究点 (2)

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