Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-27 @ 5:11 PM
Study NCT ID:
NCT04942561
Status:
COMPLETED
Last Update Posted:
2021-07-01
First Post:
2021-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR to Reduce Pain/Anxiety During IV Starts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-06-18', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'Approximately 5 minutes to one hour before procedure', 'description': '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'}, {'measure': 'Faces Pain Scale-Revised (FPS-R)', 'timeFrame': 'Approximately 5 minutes to one hour before procedure', 'description': 'Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how they are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity.'}], 'secondaryOutcomes': [{'measure': 'Gold & Rizzo Immersion/Presence (GRIP) Inventory', 'timeFrame': 'Approximately 5 minutes to one hour before procedure', 'description': "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."}, {'measure': 'Childhood Anxiety Sensitivity Index (CASI)', 'timeFrame': 'Approximately 5 minutes to one hour before procedure', 'description': 'This 18-item measure utilizes a three-point Likert scale (none (1), some (2), a lot (3)) to assess how negatively patients view anxiety symptoms. Items are summed with a higher score indicating greater anxiety sensitivity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IV Stick', 'Pain', 'Anxiety', 'Virtual Reality', 'Radiology'], 'conditions': ['Radiology']}, 'referencesModule': {'references': [{'pmid': '29053848', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28644422', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32012042', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '16466904', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16093522', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30362982', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30711327', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26424196', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18201933', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31135178', 'type': 'BACKGROUND', 'citation': '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. 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Epub 2010 Mar 26.'}, {'pmid': '31518319', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25972074', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24892196', 'type': 'BACKGROUND', 'citation': 'Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction technique in chronic pain patients. 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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.'}, {'pmid': '14756933', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33585832', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31889358', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30284748', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32511154', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23580493', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29155488', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for Children:\n\n1. Children who are 10-21 years old\n2. Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)\n3. Children who are undergoing PIVC access in the Department of Radiology and Imaging or the outpatient Infusion Center.\n4. 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.\n\nInclusion criteria for healthcare providers:\n\n1. Healthcare providers must be 18 years old or older\n2. Healthcare providers must be Children's Hospital Los Angeles staff\n3. Healthcare providers may participate if they have witnessed and/or administered the medical procedure\n\nExclusion Criteria:\n\n1. Children who are currently taking pain medication or anxiolytic medication will be excluded from this study.\n2. Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders\n3. Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks\n4. Children with a history of seizure disorder.\n5. Children currently sick with flu-like symptoms or experiencing a headache or earache.\n6. Children with known or suspected motion sickness"}, 'identificationModule': {'nctId': 'NCT04942561', 'briefTitle': 'VR to Reduce Pain/Anxiety During IV Starts', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Effect of Immersive Virtual Reality on Pain and Anxiety in Pediatric Peripheral Intravenous Catheter Access: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CHLA-15-00549_A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care (No VR) Randomization', 'description': '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).'}, {'type': 'EXPERIMENTAL', 'label': 'VR Randomization', 'description': '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.', 'interventionNames': ['Device: Samsung Gear VR', 'Device: Merge VR']}], 'interventions': [{'name': 'Samsung Gear VR', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['VR Randomization']}, {'name': 'Merge VR', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['VR Randomization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jeffrey I Gold, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'collaborators': [{'name': 'AppliedVR Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jeffrey I Gold, PhD', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}