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临床试验/NCT03495531
NCT03495531已完成不适用

Virtual Reality Obstetrics Phase 1 & Phase 2 Prospective Study

Stanford University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月3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
入组人数
60
试验地点
1
主要终点
Virtual Reality vs Standard Of Care

研究概览

简要总结

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety and pain scores in women who are undergoing child laboring procedures. The anticipated primary outcome will be a reduction of pregnant females overall anxiety and pain scores before and after such procedure(s), including but not limited to epidural/combined spinal epidural (CSE), IV placement and/or labor.

详细描述

Phase 1 There will be 3 stages that are sequentially and chronologically timed in order to asses the efficacy of Virtual Reality (VR) in the reducing epidural/combined spinal-epidural (CSE) related pain and anxiety at every stage. Phase 1 is the development phase where the focus is primarily on feasibility for Phase 2. The exclusion criteria will remain the same for all the stages and includes (i) participants and patients who do not consent (ii) have significant cognitive impairment (iii) have a history of severe motion sickness (iv) currently have nausea (v) currently experiencing seizures (vi) have visual problems(vii) are clinically unstable or require urgent/emergent intervention and/or (viii) are Non-English Speaking. Inclusion criteria is that females are (i)18 years or older and (ii) who had either have a history of, planning to have, or currently having an child laboring related procedures such as IV placement, epidural/CSE placement and/or labor.

(Stage 1) The first stage will include 10 females who are not pregnant, but have previously have at least undergone one labor epidural/CSE in the past. These mothers will be approached by a clinician or healthcare provider at Lucille Packard Children's Hospital (LPCH) outpatient surgical procedures as they wait for their child. If they are interested, the healthcare provider will let the research staff know of the eligible participant. During the mother's wait time, the research assistant will review the study, go over the consent forms and answer any questions in regards to their participation in the study. Once the participant is consented into the study, the research assistant will provide the participant with a survey regarding their recall pain and anxiety (refer to section 16) during their most recent epidural (if participant has had previously had more than one). The research assistant will then provide the participant with a VR headset and guide them through a series of VR scenery, shortly after the VR simulation the participant will be given a feedback survey in regards to their VR experience.

(Stage 2) The second stage will include 10 different females who are currently either in their second or third trimester of pregnancy. These mothers will be approached by a clinician or healthcare provider during their visits to obstetrics clinic at LPCH and Stanford Health Care (SHC) facilities. If they are interested, the healthcare provider will let the research staff know of the eligible participant. During the patients wait time, the research assistant will review the study, go over the consent forms and answer any questions in regards to their participation in the study. Once the participant is consented into the study, the research assistant will provide the participant with a survey regarding their current anxiety about labor and epidural/CSE placement. The research assistant will then provide the participant with a VR headset and guide them through a series of VR scenery, shortly after the VR simulation the participant will be given a feedback survey in regards to their VR experience. Since this cohort can give the investigators better guidance of intolerance (i.e nausea and dizziness) during VR simulation, the clinicians and research providers have come up with a safety threshold: if more than 20 percent of patients answer to a score of 4 or higher on questions regarding nausea and dizziness, the clinicians and health care providers will have to go back and iterate on VR software and repeat the previous stage before moving on stage 3.

(Stage 3) If stage 2 outcomes meet the investigator's criteria, the clinical team will move on to the last stage of 10 different females who are currently in labor and planning on undergoing an epidural for child-laboring. These mothers will be approached by their obstetric anesthesiologist during their first anesthesia consult after being admitted into LPCH labor and delivery facilities. If they are interested, the anesthesiologist will let the research staff know of the eligible participant. During the patients wait time, the research assistant and/or anesthesiologist will review the study, go over the consent forms and answer any questions in regards to their participation in the study. Once the patient is consented into the study, the research assistant and/or anesthesiologist will provide the participant with a survey regarding their pre-epidural anxiety and pain scores. The anesthesiologist and/or research assistant will then provide the laboring mother with a VR headset during epidural/CSE placement by anesthesiologist. Depending on the mother's laboring timeline, if possible, mother will receive VR feedback survey and post-epidural anxiety and pain scores. If not, mothers will receive post-epidural anxiety and pain scores where they recall these scores and fill out VR feedback survey postpartum.

Phase 2:

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Age 18 and over
  • •Able to consent
  • •Obstetric patients who had either have a history of, planning to have, or currently having an child laboring related procedures such as IV placement, epidural/CSE placement and/or labor.

排除标准

  • •Inclusion Criteria:
  • •Age 18 and over
  • •Able to consent
  • •Obstetric patients who had either have a history of, planning to have, or currently having an child laboring related procedures such as IV placement, epidural/CSE placement and/or labor.

研究组 & 干预措施

Standard of Care

No Intervention

Standard of Care

VR Use

Experimental

Obstetrics patients who use virtual reality

干预措施: Virtual Reality (Device)

结局指标

主要结局

Virtual Reality vs Standard Of Care

时间窗: Throughout Study Completion, an average of 1-2 years.

Investigators hope to determine if technology based distractions (VR headsets) are more effective than standard of care in obstetric patients for preventing high anxiety and pain during laboring procedures. This will be assessed using pre-/post- surveys.

次要结局

  • Epidural/Combined Spinal-Epidural Dosing Requirements(Duration of procedure, which is generally less than 2 hours)
  • Overall Change in Pain Scores Using Virtual Reality(Duration of procedure, which is generally less than 2 hours)
  • Parent/Patient Assessment of Virtual Reality Software(Evaluated post procedure, between 5-60 minutes after such procedure.)
  • Overall Change in Anxiety Scores Using Virtual Reality(Duration of procedure, which is generally less than 2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samuel Rodriguez

Clinical Assistant Professor

Stanford University

研究点 (1)

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