Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-26 @ 9:09 PM
Study NCT ID:
NCT04853303
Status:
UNKNOWN
Last Update Posted:
2021-05-20
First Post:
2021-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D000070263', 'term': 'Sleep Hygiene'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-04-16', 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Pediatric Nausea Assessment Tool (PeNAT) at the 6-month follow-up', 'timeFrame': 'at the 6-month follow-up', 'description': 'Children will be required o fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at 6-month follow-up. The score ranges from 1 to 4. Higher scores represent a more severe nausea.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up', 'timeFrame': 'at the 6-month follow-up', 'description': 'Children will be required to fill in the Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up. The score ranges from 0 to 21. Higher scores represent to poorer sleep quality.'}, {'measure': 'Visual Analogue Pain Scale (VAS) at the 6-month follow-up', 'timeFrame': 'at the 6-month follow-up', 'description': 'Children will be required to fill in the Visual Analogue Pain Scale (VAS) at 6-month follow-up. The score ranges from 0 to 10. Higher scores represent a higher level of pain.'}], 'secondaryOutcomes': [{'measure': 'The Pediatric Nausea Assessment Tool (PeNAT) at baseline', 'timeFrame': 'at baseline', 'description': 'Children will be required to fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at baseline. The score ranges from 1 to 4. Higher scores represent a more severe nausea.'}, {'measure': 'The Pediatric Nausea Assessment Tool (PeNAT) at 1-month follow-up', 'timeFrame': 'at 1-month follow-up', 'description': 'Children will be required to fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at 1-month follow-up.The score ranges from 1 to 4. Higher scores represent a more severe nausea.'}, {'measure': 'The Pediatric Nausea Assessment Tool (PeNAT) at 3-month follow-up', 'timeFrame': 'at 3-month follow-up', 'description': 'Children will be required to fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at 3-month follow-up. The score ranges from 1 to 4. Higher scores represent a more severe nausea.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI) at baseline', 'timeFrame': 'at baseline', 'description': 'Children will be required to fill in the Pittsburgh Sleep Quality Index (PSQI) at baseline. The score ranges from 0 to 21. Higher scores represent to poorer sleep quality.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI) at 1-month follow-up', 'timeFrame': 'at 1-month follow-up', 'description': 'Children will be required to fill in the Pittsburgh Sleep Quality Index (PSQI) at 1-month follow-up. The score ranges from 0 to 21. Higher scores represent to poorer sleep quality.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up', 'timeFrame': 'at 3-month follow-up', 'description': 'Children will be required to fill in the Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up. The score ranges from 0 to 21. Higher scores represent to poorer sleep quality.'}, {'measure': 'Visual Analogue Pain Scale (VAS) at baseline', 'timeFrame': 'at baseline', 'description': 'Children will be required to fill in the Visual Analogue Pain Scale (VAS) at baseline. The score ranges from 0 to 10. Higher scores represent a higher level of pain.'}, {'measure': 'Visual Analogue Pain Scale (VAS) at 1-month follow-up', 'timeFrame': 'at 1-month follow-up', 'description': 'Children will be required to fill in the Visual Analogue Pain Scale (VAS) at 1-month follow-up. The score ranges from 0 to 10. Higher scores represent a higher level of pain.'}, {'measure': 'Visual Analogue Pain Scale (VAS) at 3-month follow-up', 'timeFrame': 'at 3-month follow-up', 'description': 'Children will be required to fill in the Visual Analogue Pain Scale (VAS) at 3-month follow-up. The score ranges from 0 to 10. Higher scores represent a higher level of pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasms', 'Child', 'Nausea', 'Vomiting', 'Sleep Hygiene', 'Pain']}, 'descriptionModule': {'briefSummary': "Chemotherapy-induced nausea and vomiting, sleep quality and pain are the common symptoms experienced by children with cancer. These symptoms significantly devastate the children's quality of life. Hypnosis is found to be effective in managing chemotherapy-induced nausea and vomiting, sleep quality and pain in children with cancer. In addition, virtual reality is shown to promote the effectiveness of hypnosis in managing these symptoms. However, no study so far has examine it effectiveness in Hong Kong Chinese children with cancer. This study aims to investigate the effectiveness in the use a virtual reality device to improve chemotherapy-induced nausea and vomiting, sleep quality and pain among children with cancer in Hong Kong.", 'detailedDescription': 'This study is a randomized controlled trial. We recruit 180 children with cancer who are aged 9 to 18 and Chinese speaking and allocate them into experimental and control group. The experimental group will receive a 15-minute hypnosis using virtual reality when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain. The control group will receive no intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 9 to 18\n* Can read Chinese and speak Cantonese\n* diagnosed with cancer\n\nExclusion Criteria:\n\n* with mental disabilities or cognitive dysfunction as identified in the medical record'}, 'identificationModule': {'nctId': 'NCT04853303', 'briefTitle': 'VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'The Use of a Virtual Reality Device (HypnoVR®) to Improve Chemotherapy-induced Nausea and Vomiting, Sleep Quality and Pain Among Children With Cancer in Hong Kong', 'orgStudyIdInfo': {'id': 'hypnoVR-NVSP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnosis VR', 'description': 'The experimental group will receive a 15-minute hypnosis using virtual reality when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain.', 'interventionNames': ['Device: Hypnosis VR']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will receive no intervention.'}], 'interventions': [{'name': 'Hypnosis VR', 'type': 'DEVICE', 'description': 'Children will be required to wear a VR gadget for hypnosis when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain. The duration is 15 minutes.', 'armGroupLabels': ['Hypnosis VR']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eva Ho, PhD', 'role': 'CONTACT', 'email': 'kyanho@polyu.edu.hk', 'phone': '27666417'}, {'name': 'Katherine Lam, PhD', 'role': 'CONTACT', 'email': 'kwkatlam@polyu.edu.hk', 'phone': '27666420'}], 'overallOfficials': [{'name': 'Eva Ho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Eva Ho', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}