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
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
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California
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Los Angeles、California、美国、90027
- Children's Hospital Los Angeles
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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:
- Children who are 10-21 years old
- Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
- Children who are undergoing PIVC access in the Department of Radiology and Imaging or the outpatient Infusion Center.
- 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:
- Healthcare providers must be 18 years old or older
- Healthcare providers must be Children's Hospital Los Angeles staff
- Healthcare providers may participate if they have witnessed and/or administered the medical procedure
Exclusion Criteria:
- Children who are currently taking pain medication or anxiolytic medication will be excluded from this study.
- Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
- Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
- Children with a history of seizure disorder.
- Children currently sick with flu-like symptoms or experiencing a headache or earache.
- 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 |
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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).
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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.
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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.
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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 |
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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
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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。
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手术前约 5 分钟至 1 小时
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Visual Analogue Scale (VAS)
大体时间:Approximately 5 minutes to one hour before procedure
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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
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Approximately 5 minutes to one hour before procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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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
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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。
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手术前约 5 分钟至 1 小时
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Gold & Rizzo Immersion/Presence (GRIP) Inventory
大体时间:Approximately 5 minutes to one hour before procedure
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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.
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Approximately 5 minutes to one hour before procedure
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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
- Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
- Hua Y, Qiu R, Yao WY, Zhang Q, Chen XL. The Effect of Virtual Reality Distraction on Pain Relief During Dressing Changes in Children with Chronic Wounds on Lower Limbs. Pain Manag Nurs. 2015 Oct;16(5):685-91. doi: 10.1016/j.pmn.2015.03.001. Epub 2015 May 9.
- Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr. 2005 Mar 3;5(1):1. doi: 10.1186/1471-2431-5-1.
- Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.
- Bringuier S, Dadure C, Raux O, Dubois A, Picot MC, Capdevila X. The perioperative validity of the visual analog anxiety scale in children: a discriminant and useful instrument in routine clinical practice to optimize postoperative pain management. Anesth Analg. 2009 Sep;109(3):737-44. doi: 10.1213/ane.0b013e3181af00e4.
- Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
- Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.
- Gershon J, Zimand E, Lemos R, Rothbaum BO, Hodges L. Use of virtual reality as a distractor for painful procedures in a patient with pediatric cancer: a case study. Cyberpsychol Behav. 2003 Dec;6(6):657-61. doi: 10.1089/109493103322725450.
- Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20.
- Walther-Larsen S, Petersen T, Friis SM, Aagaard G, Drivenes B, Opstrup P. Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. Hosp Pediatr. 2019 Jul;9(7):501-507. doi: 10.1542/hpeds.2018-0249. Epub 2019 Jun 3.
- Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.
- Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.
- Gershon J, Zimand E, Pickering M, Rothbaum BO, Hodges L. A pilot and feasibility study of virtual reality as a distraction for children with cancer. J Am Acad Child Adolesc Psychiatry. 2004 Oct;43(10):1243-9. doi: 10.1097/01.chi.0000135621.23145.05.
- Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
- Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.
- Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12.
- Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. doi: 10.14219/jada.archive.2009.0102.
- Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction technique in chronic pain patients. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):346-52. doi: 10.1089/cyber.2014.0207.
- Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive Virtual Reality for Pediatric Pain. Children (Basel). 2017 Jun 23;4(7):52. doi: 10.3390/children4070052.
- Schneider SM, Kisby CK, Flint EP. Effect of virtual reality on time perception in patients receiving chemotherapy. Support Care Cancer. 2011 Apr;19(4):555-64. doi: 10.1007/s00520-010-0852-7. Epub 2010 Mar 26.
- Spiegel B, Fuller G, Lopez M, Dupuy T, Noah B, Howard A, Albert M, Tashjian V, Lam R, Ahn J, Dailey F, Rosen BT, Vrahas M, Little M, Garlich J, Dzubur E, IsHak W, Danovitch I. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial. PLoS One. 2019 Aug 14;14(8):e0219115. doi: 10.1371/journal.pone.0219115. eCollection 2019.
- Ahmadpour N, Keep M, Janssen A, Rouf AS, Marthick M. Design Strategies for Virtual Reality Interventions for Managing Pain and Anxiety in Children and Adolescents: Scoping Review. JMIR Serious Games. 2020 Jan 31;8(1):e14565. doi: 10.2196/14565.
- Matsangidou M, Ang CS, Sakel M. Clinical utility of virtual reality in pain management: a comprehensive research review. Br J Neurosci Nurs. 2017;13(3):133-143. doi:10.12968/bjnn.2017.13.3.133
- Deacon B, Abramowitz J. Anxiety sensitivity and its dimensions across the anxiety disorders. J Anxiety Disord. 2006;20(7):837-57. doi: 10.1016/j.janxdis.2006.01.003. Epub 2006 Feb 8.
- Kazak AE, Kassam-Adams N, Schneider S, Zelikovsky N, Alderfer MA, Rourke M. An integrative model of pediatric medical traumatic stress. J Pediatr Psychol. 2006 May;31(4):343-55. doi: 10.1093/jpepsy/jsj054. Epub 2005 Aug 10.
- Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.
- Kucuk Alemdar D, Yaman Aktas Y. The Use of the Buzzy, Jet Lidokaine, Bubble-blowing and Aromatherapy for Reducing Pediatric Pain, Stress and Fear Associated with Phlebotomy. J Pediatr Nurs. 2019 Mar-Apr;45:e64-e72. doi: 10.1016/j.pedn.2019.01.010. Epub 2019 Jan 30.
- Thrane SE, Wanless S, Cohen SM, Danford CA. The Assessment and Non-Pharmacologic Treatment of Procedural Pain From Infancy to School Age Through a Developmental Lens: A Synthesis of Evidence With Recommendations. J Pediatr Nurs. 2016 Jan-Feb;31(1):e23-32. doi: 10.1016/j.pedn.2015.09.002. Epub 2015 Sep 28.
- Bandstra NF, Skinner L, Leblanc C, Chambers CT, Hollon EC, Brennan D, Beaver C. The role of child life in pediatric pain management: a survey of child life specialists. J Pain. 2008 Apr;9(4):320-9. doi: 10.1016/j.jpain.2007.11.004. Epub 2008 Jan 16.
- Dumoulin S, Bouchard S, Ellis J, Lavoie KL, Vezina MP, Charbonneau P, Tardif J, Hajjar A. A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. Games Health J. 2019 Aug;8(4):285-293. doi: 10.1089/g4h.2018.0111. Epub 2019 May 24.
- Dunn A, Patterson J, Biega CF, Grishchenko A, Luna J, Stanek JR, Strouse R. A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial. JMIR Serious Games. 2019 Jan 9;7(1):e10902. doi: 10.2196/10902.
- Morris LD, Louw QA, Grimmer-Somers K. The effectiveness of virtual reality on reducing pain and anxiety in burn injury patients: a systematic review. Clin J Pain. 2009 Nov-Dec;25(9):815-26. doi: 10.1097/AJP.0b013e3181aaa909.
- Ashmore J, Di Pietro J, Williams K, Stokes E, Symons A, Smith M, Clegg L, McGrath C. A Free Virtual Reality Experience to Prepare Pediatric Patients for Magnetic Resonance Imaging: Cross-Sectional Questionnaire Study. JMIR Pediatr Parent. 2019 Apr 18;2(1):e11684. doi: 10.2196/11684.
- Neugebauer V, Li W, Bird GC, Han JS. The amygdala and persistent pain. Neuroscientist. 2004 Jun;10(3):221-34. doi: 10.1177/1073858403261077.
- Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, Lam C, Liu L, Foster S, Sambell R, Jeyachanthiran K, Crock C, Stock A, Hopper SM, Cohen S, Davidson A, Plummer K, Mills E, Craig SS, Deng G, Leong P. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.
- Wong CL, Lui MMW, Choi KC. Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial. Trials. 2019 Jun 20;20(1):369. doi: 10.1186/s13063-019-3443-z.
- Silverman WK, Fleisig W, Rabian B, Peterson RA. Child Anxiety Sensitivity Index. J Clin Child Psychol. 1991;20(2):162-168. doi:10.1207/s15374424jccp2002_7
- Vadivelu N, Kai AM, Kodumudi V, Sramcik J, Kaye AD. The Opioid Crisis: a Comprehensive Overview. Curr Pain Headache Rep. 2018 Feb 23;22(3):16. doi: 10.1007/s11916-018-0670-z.
- Amin AM, Tong X, Gromala D, Shaw CD. Cardboard Mobile Virtual Reality as an Approach for Pain Distraction in Clinical Settings: Comparison, Exploration and Evaluation with Oculus Rift. In: Proceedings of the 2017 CHI Conference Extended Abstracts on Human Factors in Computing Systems. CHI EA '17. Association for Computing Machinery; 2017:2345-2351. doi:10.1145/3027063.3053234
- Hendricks TM, Gutierrez CN, Stulak JM, Dearani JA, Miller JD. The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. Mayo Clin Proc. 2020 Jun;95(6):1148-1157. doi: 10.1016/j.mayocp.2020.02.032.
- Firoozabadi R, Elhaddad M, Drever S, Soltani M, Githens M, Kleweno CP, Sharar SR, Patterson DR, Hoffman HG. Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study. Front Virtual Real. 2020 Dec;1:553492. doi: 10.3389/frvir.2020.553492. Epub 2020 Dec 14.
- Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.
- Thomas JJ, Albietz J, Polaner D. Virtual reality for lumbar puncture in a morbidly obese patient with leukemia. Paediatr Anaesth. 2018 Nov;28(11):1059-1060. doi: 10.1111/pan.13505. Epub 2018 Oct 4.
- Wong CL, Li CK, Chan CWH, Choi KC, Chen J, Yeung MT, Chan ON. Virtual Reality Intervention Targeting Pain and Anxiety Among Pediatric Cancer Patients Undergoing Peripheral Intravenous Cannulation: A Randomized Controlled Trial. Cancer Nurs. 2021 Nov-Dec 01;44(6):435-442. doi: 10.1097/NCC.0000000000000844.
- Loreto-Quijada D, Gutierrez-Maldonado J, Gutierrez-Martinez O, Nieto R. Testing a virtual reality intervention for pain control. Eur J Pain. 2013 Oct;17(9):1403-10. doi: 10.1002/j.1532-2149.2013.00316.x. Epub 2013 Apr 12.
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
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
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University Hospital MuensterPalliativnetz Muenster gGmbH未知
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Children's Hospital Los AngelesAppliedVR Inc.招聘中
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University of Maryland, Baltimore尚未招聘