Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-02-26 @ 5:05 PM
Study NCT ID:
NCT06446518
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2024-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Virtual Reality for Perioperative Anxiolysis in Adolescents Undergoing MIRPE Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005660', 'term': 'Funnel Chest'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in anxiety', 'timeFrame': '1-2 days', 'description': 'Anxiety assessed by STAI-S and STAI-T questionnaires level of anxiety will be assessed using the State Trait Anxiety-Inventory. The test is composed of 2 parts: STAI-S (How does the patient feel right now?) and STAI-T (How does the patient feel on average?). Both questionnaires contain 20 questions with answers rating from 1 to 4.'}], 'secondaryOutcomes': [{'measure': 'Change in pain and vital parameters', 'timeFrame': '1-2 days', 'description': 'Pain assessed by Numerical Pain Rating Scale level of pain will be assessed using the Numerical Pain Rating Scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable).\n\nVital parameters that are monitored during the study are blood pressure, heart rate, peripheral oxygen saturation and respiratory rate.\n\nPain will also be followed with analgesic demand per patien during the first postoperative day.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pectus Excavatum', 'Pectus Deformity']}, 'referencesModule': {'references': [{'pmid': '10320165', 'type': 'BACKGROUND', 'citation': 'Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.'}, {'pmid': '8953995', 'type': 'BACKGROUND', 'citation': "Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002."}, {'pmid': '18355741', 'type': 'BACKGROUND', 'citation': 'Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L. Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr. 2008 Mar-Apr;8(2):117-28. doi: 10.1016/j.ambp.2007.12.005.'}, {'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': '34962159', 'type': 'BACKGROUND', 'citation': 'Esposito C, Autorino G, Iervolino A, Vozzella EA, Cerulo M, Esposito G, Coppola V, Carulli R, Cortese G, Gallo L, Escolino M. Efficacy of a Virtual Reality Program in Pediatric Surgery to Reduce Anxiety and Distress Symptoms in the Preoperative Phase: A Prospective Randomized Clinical Trial. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):197-203. doi: 10.1089/lap.2021.0566. Epub 2021 Dec 28.'}, {'pmid': '34006462', 'type': 'BACKGROUND', 'citation': "Buyuk ET, Odabasoglu E, Uzsen H, Koyun M. The effect of virtual reality on Children's anxiety, fear, and pain levels before circumcision. J Pediatr Urol. 2021 Aug;17(4):567.e1-567.e8. doi: 10.1016/j.jpurol.2021.04.008. Epub 2021 Apr 21."}, {'pmid': '32618627', 'type': 'BACKGROUND', 'citation': 'Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.'}, {'pmid': '18089143', 'type': 'BACKGROUND', 'citation': 'Rumsey N, Harcourt D. Body image and disfigurement: issues and interventions. Body Image. 2004 Jan;1(1):83-97. doi: 10.1016/S1740-1445(03)00005-6.'}, {'pmid': '35185624', 'type': 'BACKGROUND', 'citation': 'Casatori L, Pellegrino A, Messineo A, Ghionzoli M, Facchini F, Modesti A, Modesti PA. Differential Influence of Physical Activity on Cardiopulmonary Performance and Stroke Volume Assessed at Cardiopulmonary Exercise Test in Pectus Excavatum: A Pilot Study. Front Physiol. 2022 Feb 3;13:831504. doi: 10.3389/fphys.2022.831504. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'In this randomized control trial, investigators would like to assess as primary objective the effectiveness of VR in anxiolysis via using State Trait Anxiety- Inventory test various time during the perioperative period with recorded physiologic data. As a secondary objective they are investigating the use of VR in the postoperative period for pain modulation via using pain numeric rating scales (NRS), monitoring physiologic data, and collecting information on painkiller demand of the patients.', 'detailedDescription': 'This prospective, randomized controlled trial will be conducted with participants from the Paediatric Center, Semmelweis University, a tertiary level health care centre based in Budapest, Hungary. We evaluate the effects of VR immersion on reducing perioperative anxiety and postoperative pain.\n\nParticipants will be asked to wear a VR headset for preferably an hour before and after the surgery. Patients will be asked to fill out three anxiety tests meanwhile investigators will record their vital parameters (HR, RR, SpO2, BP): on admission, in the operating room and on the surgical ward on the day after surgery. In the first postoperative day vital parameters, analgesic demand and NRS score will be recorded to follow patients pain status.\n\nResearchers will compare VR group to control group to see if anxiety and pain was different among those who recieved the VR headset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient between 13-18 years old\n* reported chest deformity (pectus excavatum/ carinatum)\n* patients undergoing MIRPE surgery in general anesthesia\n* Hungarian fluency\n* willing to comply with study procedures.\n\nExclusion Criteria:\n\n* gross cognitive impairment that would interfere with the ability to consent or complete study procedures.\n* Head injury\n* Head infection\n* Altered mental status (independently from midazolam)\n* Scabies or louse\n* Dizziness or vertigo\n* Blindness or severe vision loss\n* Lack of parental/ guardian or patient consent\n* Those, who has a head deformity, so VR headset does not fit well'}, 'identificationModule': {'nctId': 'NCT06446518', 'briefTitle': 'Assessing Virtual Reality for Perioperative Anxiolysis in Adolescents Undergoing MIRPE Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'A Randomized Control Trial for Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery', 'orgStudyIdInfo': {'id': 'NRG 2022/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR intervention group', 'description': 'On admission, patients are asked to fill out a STAI-T and-S anxiety inventory. Attending investigator will take vital parameters upon admission.\n\nPatients are asked to use the VR headset a minimum of 1 hour before surgery. Participants are asked to fill out a STAI-S test in the operating room, where physiologic data is collected and timing and dose of medication administered. After surgery, during emergence physiologic data is collected, and attending anesthesiologist fills out the PAED score. Patients are encouraged to use the VR headset after surgery, any time when they feel comfortable.\n\nPain using an NRS scale, and vital parameters are monitored postoperative 1, 2, 3, 6, 12 hours (if patient is not sleeping) and in the morning following surgery at 6 and 9 am. A final STAI-S test is filled out by patients in the morning after surgery. Data regarding painkiller demand is collected after surgery.', 'interventionNames': ['Device: Virtual reality exposure']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'On admission, patients are asked to fill out a STAI-T and-S anxiety inventory. Attending investigator will take vital parameters upon admission.\n\nParticipants are asked to fill out a STAI-S test in the operating room, where physiologic data is collected and timing and dose of medication administered. After surgery, during emergence physiologic data is collected, and attending anesthesiologist fills out the PAED score.\n\nPain using an NRS scale, and vital parameters are monitored postoperative 1, 2, 3, 6, 12 hours (if patient is not sleeping) and in the morning following surgery at 6 and 9 am. A final STAI-S test is filled out by patients in the morning after surgery. Data regarding painkiller demand is collected after surgery.'}], 'interventions': [{'name': 'Virtual reality exposure', 'type': 'DEVICE', 'description': 'Assessing immersive virtual reality as a distraction tool in anxiolysis and pain modulation.', 'armGroupLabels': ['VR intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1083', 'city': 'Budapest', 'state': 'Budapest', 'country': 'Hungary', 'facility': 'Paediatric Centre, Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All relevant variables, that was collected during the study period will be shared after deidentifying the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Új Nemzeti Kiválóság Program', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Agnes Jermendy MD PhD MPH', 'investigatorAffiliation': 'Semmelweis University'}}}}