Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-31 @ 1:58 AM
Study NCT ID:
NCT06516003
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR for Lac Repairs in Peds Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D022125', 'term': 'Lacerations'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-27', 'size': 618947, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-02T16:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'Assessed immediately after intervention', 'description': 'Using Wong Baker Faces Pain Scale'}, {'measure': 'Fear Score', 'timeFrame': 'Assessed immediately after intervention', 'description': "Using Children's Fear Score"}], 'secondaryOutcomes': [{'measure': 'Satisfaction of procedure', 'timeFrame': 'Assessed immediately after intervention', 'description': 'Assessed by Likert- type scale question'}, {'measure': 'Side Effects', 'timeFrame': 'Assessed immediately after intervention', 'description': 'nausea, vomiting, dizziness, headache, other'}, {'measure': 'Duration of procedure', 'timeFrame': 'Assessed immediately after intervention', 'description': 'Five minute intervals up to 25 minutes'}, {'measure': 'Future Use', 'timeFrame': 'Assessed immediately after intervention', 'description': 'Would they recommend use of VR for same procedure again'}, {'measure': 'Physical Holding', 'timeFrame': 'Assessed immediately after intervention', 'description': 'Did patient need to be held for the procedure'}, {'measure': 'Anxiolytic Use', 'timeFrame': 'Assessed immediately after intervention', 'description': 'Did patient need anxiolytics for the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'pediatrics', 'emergency department'], 'conditions': ['Laceration']}, 'referencesModule': {'references': [{'pmid': '38724104', 'type': 'BACKGROUND', 'citation': 'Martin SR, Heyming TW, Fortier MA, Kain ZN. Paediatric laceration repair in the emergency department: post-discharge pain and maladaptive behavioural changes. Emerg Med J. 2024 Jul 22;41(8):469-474. doi: 10.1136/emermed-2023-213858.'}, {'pmid': '11739597', 'type': 'BACKGROUND', 'citation': 'Ploghaus A, Narain C, Beckmann CF, Clare S, Bantick S, Wise R, Matthews PM, Rawlins JN, Tracey I. Exacerbation of pain by anxiety is associated with activity in a hippocampal network. J Neurosci. 2001 Dec 15;21(24):9896-903. doi: 10.1523/JNEUROSCI.21-24-09896.2001.'}, {'pmid': '31047650', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34746980', 'type': 'BACKGROUND', 'citation': 'Kumar K, Ali S, Sabhaney V, Trottier E, Drendel A, Bhatt M, Boisvert L, Poonai N; Pediatric Emergency Research Canada. Anxiolysis for laceration repair in children: a survey of pediatric emergency providers in Canada. CJEM. 2022 Jan;24(1):75-83. doi: 10.1007/s43678-021-00210-y. Epub 2021 Nov 8.'}, {'pmid': '26720064', 'type': 'BACKGROUND', 'citation': 'Ali S, McGrath T, Drendel AL. An Evidence-Based Approach to Minimizing Acute Procedural Pain in the Emergency Department and Beyond. Pediatr Emerg Care. 2016 Jan;32(1):36-42; quiz 43-4. doi: 10.1097/PEC.0000000000000669.'}, {'pmid': '32711948', 'type': 'BACKGROUND', 'citation': 'Arikan A, Esenay FI. Active and Passive Distraction Interventions in a Pediatric Emergency Department to Reduce the Pain and Anxiety During Venous Blood Sampling: A Randomized Clinical Trial. J Emerg Nurs. 2020 Nov;46(6):779-790. doi: 10.1016/j.jen.2020.05.004. Epub 2020 Jul 22.'}, {'pmid': '31501078', 'type': 'BACKGROUND', 'citation': 'Aykanat Girgin B, Gol I. Reducing Pain and Fear in Children During Venipuncture: A Randomized Controlled Study. Pain Manag Nurs. 2020 Jun;21(3):276-282. doi: 10.1016/j.pmn.2019.07.006. Epub 2019 Sep 26.'}, {'pmid': '31136330', 'type': 'BACKGROUND', 'citation': 'Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.'}, {'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': '29237632', 'type': 'BACKGROUND', 'citation': 'Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.'}, {'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.'}, {'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': '31440148', 'type': 'BACKGROUND', 'citation': 'Hoffman HG, Rodriguez RA, Gonzalez M, Bernardy M, Pena R, Beck W, Patterson DR, Meyer WJ 3rd. Immersive Virtual Reality as an Adjunctive Non-opioid Analgesic for Pre-dominantly Latin American Children With Large Severe Burn Wounds During Burn Wound Cleaning in the Intensive Care Unit: A Pilot Study. Front Hum Neurosci. 2019 Aug 8;13:262. doi: 10.3389/fnhum.2019.00262. eCollection 2019.'}, {'pmid': '29722606', 'type': 'BACKGROUND', 'citation': 'Chad R, Emaan S, Jillian O. Effect of virtual reality headset for pediatric fear and pain distraction during immunization. Pain Manag. 2018 May;8(3):175-179. doi: 10.2217/pmt-2017-0040. Epub 2018 May 3.'}, {'pmid': '30730798', 'type': 'BACKGROUND', 'citation': 'Shetty V, Suresh LR, Hegde AM. Effect of Virtual Reality Distraction on Pain and Anxiety During Dental Treatment in 5 to 8 Year Old Children. J Clin Pediatr Dent. 2019;43(2):97-102. doi: 10.17796/1053-4625-43.2.5. Epub 2019 Feb 7.'}, {'pmid': '24823326', 'type': 'BACKGROUND', 'citation': 'Jeffs D, Dorman D, Brown S, Files A, Graves T, Kirk E, Meredith-Neve S, Sanders J, White B, Swearingen CJ. Effect of virtual reality on adolescent pain during burn wound care. J Burn Care Res. 2014 Sep-Oct;35(5):395-408. doi: 10.1097/BCR.0000000000000019.'}, {'pmid': '33986914', 'type': 'BACKGROUND', 'citation': 'Goldman RD, Behboudi A. Pilot Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care During Pediatric Laceration Repair. J Child Adolesc Trauma. 2021 Mar 26;14(2):295-298. doi: 10.1007/s40653-021-00350-4. eCollection 2021 Jun.'}, {'pmid': '31160472', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38466416', 'type': 'BACKGROUND', 'citation': 'Bexson C, Oldham G, Wray J. Safety of virtual reality use in children: a systematic review. Eur J Pediatr. 2024 May;183(5):2071-2090. doi: 10.1007/s00431-024-05488-5. Epub 2024 Mar 11.'}, {'pmid': '35525050', 'type': 'BACKGROUND', 'citation': 'Neiman NR, Falkson SR, Rodriguez ST, Wang EY, Hemphill SF, Khoury ME, Kist MN, Jackson CD, Caruso TJ. Quantifying virtual reality pain modulation in healthy volunteers: A randomized, crossover study. J Clin Anesth. 2022 Sep;80:110876. doi: 10.1016/j.jclinane.2022.110876. Epub 2022 May 4.'}, {'pmid': '39641640', 'type': 'DERIVED', 'citation': 'McEvoy AO, Vincent OB, Vazifedan T, Chang TP, Clingenpeel JM, Kapoor R. Virtual Reality as Active Distraction in Laceration Repair: A Game Changer? Pediatr Emerg Care. 2025 Mar 1;41(3):208-212. doi: 10.1097/PEC.0000000000003319. Epub 2024 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the clinical trial is to compare virtual reality to standard of care for laceration repairs in the pediatric emergency department. The main question it aims to answer is:\n\n-Does virtual reality decrease pain and anxiety scores compared to standard of care for laceration repairs in the pediatric emergency department?\n\nParticipants who meet the age and other inclusion criteria will be enrolled by research staff. They will complete a brief paper survey along with their guardians and the provider doing the laceration repair. The surveys will be completed after the laceration repair is finished.', 'detailedDescription': "This will be a randomized pragmatic study for all patients ages 6-17 years with simple lacerations. Simple lacerations will be defined as lacerations within the scope of pediatric emergency medicine providers AND not requiring sedation or operative intervention. Subjects will be identified by the Emergency Department staff for enrollment. The goal number of enrolled participants will be 480, including 240 patients randomized into two groups, 120 per group, and 240 parents/guardians. The Emergency Department accepted to participate in this study and ED providers will complete the provider's survey. After signing the consent and assent form when appropriate, the patients will be randomized to either receive the standard of care or standard or care with immersive virtual reality goggles. Consent and assent will be obtained in the patient rooms within the emergency department. The standard of care shall be defined to include any of the following: local analgesia (topical LET and/ or subcutaneous lidocaine), oral or intranasal midazolam, distraction, Child Life Staff, or physical holding. Because each of the aforementioned interventions may vary between patients, it cannot be truly standardized; hence, this will be considered a pragmatic study. Patients randomized to the VR arm will receive the other standard procedures as well with VR goggles as an adjunct. Exclusion criteria include a history of epilepsy, visual or hearing impairment, or intellectual disability that would preclude use of VR goggles as determined by the guardian. Additionally, any lacerations around the eyes, eyebrows, and nose will be excluded as well as patients requiring sedation. Non-English speaking patients will be excluded as well. Hand lacerations will not be excluded.\n\nParticipants will be identified by ED staff following evaluation of the laceration. The ED staff will be given a flowchart with eligibility criteria. All interested participants who meet eligibility criteria will be consented. A research team member will obtain consent from parents or guardians by providing and reviewing the consent form (see Subject Consent Form). For patients who are between 8 and 17 years of age, a research team member will obtain assent by providing and reviewing the assent form (see Subject Assent Form). Consent and assent will be obtained in the patient's ED room.\n\nPatients will be separated into groups age 6-11 and 12-17. Patients will be randomized via a selection of a sealed envelope which will contain instructions for use of the VR goggles. The goggles utilized will be Lenovo Mirage Solo with DayDream, which are standalone VR headset with Worldsense Body Tracking. Research staff will coach the child on age-appropriate games, as previously determined by Lenovo.\n\nThe goggles will be cleansed with Oxivir Tb disinfectant wipes after each use and allowed to dry in room air prior to next use. Education will be provided to all ED providers on the proper cleansing protocol for the VR goggles (Figure 4). The disinfectant protocol will be available for all users during the study, and has been approved by the director of Infection Control at Children's Hospital of the King's Daughters.\n\nFollowing the laceration repair, the patient, guardian and health care provider will be surveyed (Figure 1, 2, and 3) on paper surveys. The survey includes Likert-type scale questions, binary questions as well as incorporates the Wong Baker Faces Pain Scale and Children's Fear Scale. The duration of the procedure will be recorded by the healthcare provider who completed the laceration repair. Time of procedure will be defined as from the time of irrigation to wound dressing. Patients and parents will both be filling out their own individual surveys. The parent should complete the survey first before the child should the child need assistance with completion. Patients and parents may decline to participate in any survey at any time"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Simple lacerations that do not require surgical subspecialty repair or moderate or deep sedation\n* Hand lacerations\n* Laceration that required stitches\n\nExclusion Criteria:\n\n* less than 6 years old or greater than 17 years old\n* Non english speaking\n* Visual or hearing impairment\n* Epilepsy\n* Lacerations to forehead, nose, or cheeks where goggles cover\n* Intellectual disability that precludes participation as determined by guardian'}, 'identificationModule': {'nctId': 'NCT06516003', 'briefTitle': 'VR for Lac Repairs in Peds Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Virginia Medical School'}, 'officialTitle': 'Use of Immersive Virtual Reality for Laceration Repairs in the Pediatric Emergency Department', 'orgStudyIdInfo': {'id': '29-01-FB-0211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'description': 'Patients randomized to receive virtual reality goggles in addition to the standard of care.', 'interventionNames': ['Device: Immersive Virtual Reality Goggles']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Patients that are randomized to receive the standard of care including other distraction techniques and child life specialist.', 'interventionNames': ['Behavioral: Standard of Care']}], 'interventions': [{'name': 'Immersive Virtual Reality Goggles', 'type': 'DEVICE', 'description': "Immersive Virtual Reality goggles are a head mounted device placed over a patient's head and eyes that allows them to play in a virtual reality game.", 'armGroupLabels': ['Virtual Reality']}, {'name': 'Standard of Care', 'type': 'BEHAVIORAL', 'description': 'Distraction techniques like tablet, phone, television, parent, child life specialist', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': "Children's Hospital of the King's Daughters", 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planning to share data with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Virginia Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}