Optimizing the Patient Experience: Virtual Reality Goggle Utilization for Venipuncture Distraction - Can we Decrease Anxiety and Pain During This Common Procedure?
概览
- 阶段
- 不适用
- 干预措施
- Virtual Reality Goggles
- 疾病 / 适应症
- Pain, Procedural
- 发起方
- Montefiore Medical Center
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in Perceived Pain Scale
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
This is a randomized non-blinded trial evaluating the effect of virtual reality goggles on perceived pain and anxiety scores during venipuncture on hospitalized children ages 5-21. We will randomized patients to either standard of care (including Lidocaine 2.5%/Prilocaine 2.5% cream as a topical anesthetic 60-240 minutes prior to venipuncture) or standard of care plus virtual reality goggles.
详细描述
Study personnel will identify patients on CHAM 6 and CHAM 8 scheduled for lab draw prior to child life rounds and subsequently ask the health care providers if there are any patients that are not developmentally or physically appropriate to use the VR equipment. They will then screen and consent the patients approximately 1 hour prior to the Child Life rounds (see appendix A \& B). Patients aged 12-17 years old who are able to read the form will be asked to fill out an assent form (see appendix C) and patients aged 5-12 years old and those unable to read the form will be read the assent form to ensure verbal assent. Those patients who consent to the study will be randomized to a VR arm and non VR arm using computer generated randomization. Lidocaine 2.5%/Prilocaine 2.5% cream will be placed on all patients that have consented to the study by the patient's nurse if they don't already have it applied. After consent and assurance of topical anesthetic application, a brief demographic questionnaire (see appendix D) will also be completed. For efficiency and feasibility, two study personnel will screen and consent families, assist with VR set up and removal, and conduct post procedure assessment.
研究者
入排标准
入选标准
- •patients aged 5-21 years old admitted to the 6th floor of the inpatient unit who are scheduled for a venipuncture during morning phlebotomy rounds
排除标准
- •Patients developmentally or physically not appropriate to use the VR equipment as determined by their parent, guardian or healthcare provider, if there is discomfort related to wearing the goggles (for example: recent neurosurgery, migraines, hardware on head), patient have photosensitive seizures or infectious concern such as scabies, lice, COVID-19 that can't reliably be disinfected.
- •Patient (\>18) or Parent or guardian (for patient \< 18) that does not speak English, Spanish or Arabic will be excluded.
- •If patient refuses Lidocaine 2.5%/Prilocaine 2.5% cream use they will also be excluded from the study.
研究组 & 干预措施
VR goggle with venipuncture
Virtual reality goggles SamsungGearVR supplied by KindVR will be placed on patients at least 2 min prior to venipuncture. All patients will also receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture.
干预措施: Virtual Reality Goggles
no VR goggle with venipuncture
Patients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles.
结局指标
主要结局
Change in Perceived Pain Scale
时间窗: Approximately 1 hour prior to venipuncture and again immediately after venipuncture
Change in perceived pain from pre-venipuncture to post-venipuncture (during the blood draw) will be assessed using the Wong-Baker FACES Pain Rating scale. Children, or parents on behalf of children, will be asked to communicate the severity of the pain the child is experiencing using the FACES scale which contains a series of 6 different facial expressions correlated to numbers (i.e., 0, 2, 4, 6, 8, 10) ranging from a happy face at "0" indicating "no hurt" to a crying face at "10" indicating "hurts worst." Higher scale scores signify worse pain severity. Change in group mean FACES scale scores will be summarized by study arm and subsequently analyzed using Wilcoxon signed rank test for paired data.
次要结局
- Change in Anxiety Scores(Approximately 1 hour prior to venipuncture and again immediately after venipuncture)
- Change in Heart Rate(Approximately 1 hour prior to venipuncture and again immediate after venipuncture)
- Change in Level of simulator sickness(Approximately 1 hour prior to venipuncture and again immediately after venipuncture)
- Pre-venipuncture anxiety scores in participants with prior hospitalizations or prior medical problems.(Baseline)