此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

VR to Reduce Pain/Anxiety During IV Starts

2021年6月28日 更新者:Jeffrey I Gold, PhD、Children's Hospital Los Angeles

Effect of Immersive Virtual Reality on Pain and Anxiety in Pediatric Peripheral Intravenous Catheter Access: A Randomized Clinical Trial

This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center at CHLA, as measured by self- and proxy-report.

研究概览

地位

完全的

条件

详细说明

Distraction is a form of non pharmacological intervention for reducing pain and anxiety in children during painful medical procedures (e.g., venipuncture, IV placement). Recent technological developments in the area of virtual reality (VR) provide new and potentially more effective ways of distracting children from the pain and anxiety associated with medical procedures. While initial studies of VR pain distraction are promising, few have studied the effectiveness of the technology in children, using a multi-method approach. The current study aims to recruit 115 children ages 10-21 years and their caregivers who arrive at the hospital for peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center. Children and their parents will be randomly assigned to one of two treatment conditions: 1) existing hospital standard of care or 2) standard of care plus distraction via VR. Children and caregivers will be asked to complete measures assessing pain and anxiety both before and after the procedure. In addition, objective measures of child pain and distress during the PIVC access will be taken using coding of behavioral/verbal expressions. Univariate Analysis of Variance (ANOVA) will be used to compare differences in primary and secondary outcome variables in VR + standard of care to standard of care only conditions when pre and post-operative measures are available. Univariate ANOVA will be used to compare conditions on post-operative variables.

研究类型

介入性

注册 (实际的)

107

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Los Angeles、California、美国、90027
        • Children's Hospital Los Angeles

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

10年 至 21年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria for Children:

  1. Children who are 10-21 years old
  2. Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
  3. Children who are undergoing PIVC access in the Department of Radiology and Imaging or the outpatient Infusion Center.
  4. Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.

Inclusion criteria for healthcare providers:

  1. Healthcare providers must be 18 years old or older
  2. Healthcare providers must be Children's Hospital Los Angeles staff
  3. Healthcare providers may participate if they have witnessed and/or administered the medical procedure

Exclusion Criteria:

  1. Children who are currently taking pain medication or anxiolytic medication will be excluded from this study.
  2. Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
  3. Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
  4. Children with a history of seizure disorder.
  5. Children currently sick with flu-like symptoms or experiencing a headache or earache.
  6. Children with known or suspected motion sickness

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Standard of Care (No VR) Randomization
In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for PIVC placement (i.e., a topical numbing spray and Buzzy® Bee, a vibrating device placed near the PIVC site for pain distraction).
实验性的:VR Randomization
Children in the VR condition will undergo the invasive procedure while distracted by interaction with an immersive virtual environment (VE) presented via a head mounted display (HMD). The intervention group will receive standard CHLA treatment with VR distraction. Patients began gameplay <5 minutes before their PIVC placement and concluded after successful vascular access.
Participants 13 -21 years old can use the Samsung Gear VR. The VE is mobile based (Samsung with the Gear VR) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image. Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears. The VR game is equipped with a head-tracking system, enabling the player to look around the VE. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use to minimize chance of infection.
Participants 10-21 years can use the Merge. The VE to be used in this study is mobile based (Pixel with the Merge) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image. Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears. The VR game is equipped with a head-tracking system, enabling the player to look around the VE. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use to minimize chance of infection.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
面部疼痛量表修订版 (FPS-R)
大体时间:手术前约 5 分钟至 1 小时
修订版是 Wong-Baker 面部疼痛评定量表的更新版本,与原始测量的笑脸相比,将无疼痛描述为中性表情。 孩子被要求指着描绘他们目前因疼痛而感觉如何的卡通脸。 面部测量被认为可以测量疼痛强度,Wong-Baker 面部测量已证明具有良好的可靠性和有效性。
手术前约 5 分钟至 1 小时
Visual Analogue Scale (VAS)
大体时间:Approximately 5 minutes to one hour before procedure
The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task. The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top. Prior research used the VAS to rate anticipatory anxiety and pain in children
Approximately 5 minutes to one hour before procedure

次要结果测量

结果测量
措施说明
大体时间
儿童焦虑敏感度指数 (CASI)
大体时间:手术前约 5 分钟至 1 小时
这项包含 18 项的措施使用李克特三点量表(无 (1)、一些 (2)、很多 (3))来评估患者对焦虑症状的负面看法。 项目总分越高,表明焦虑敏感性越高。
手术前约 5 分钟至 1 小时
Gold & Rizzo Immersion/Presence (GRIP) Inventory
大体时间:Approximately 5 minutes to one hour before procedure
Gold & Rizzo Immersion/Presence (GRIP) Inventory is a Child Presence Questionnaire was developed out of a content analysis of the entire domain of adult presence items and selection and adaptation of appropriate items for assessing the child's sense of believability of their experience. This 16-item measure is verbally administered to children and asks them to respond according to a 3-point Likert-like format. Items assess the child's sense of involvement, realism, and transportation into the experience. Patients in the VR condition will complete the Child Presence Questionnaire post-procedure to assess level of VR immersion.
Approximately 5 minutes to one hour before procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年4月12日

初级完成 (实际的)

2019年7月24日

研究完成 (实际的)

2019年7月24日

研究注册日期

首次提交

2021年6月18日

首先提交符合 QC 标准的

2021年6月18日

首次发布 (实际的)

2021年6月28日

研究记录更新

最后更新发布 (实际的)

2021年7月1日

上次提交的符合 QC 标准的更新

2021年6月28日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • CHLA-15-00549_A

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Samsung Gear VR的临床试验

3
订阅