Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485869
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-03
Brief Title:
Impact of Virtual Reality on the Quality of Life of Oncology Patients
Sponsor:
Central Hospital Saint Quentin
Organization:
Central Hospital Saint Quentin
Study Overview
Official Title:
Impact of Virtual Reality on the Quality of Life of Oncology Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIRONSCARE
Brief Summary:
Anxiety nausea and vomiting are common side effects in paediatric patients receiving chemotherapy chemotherapy New evidence supports the efficacy of immersive virtual reality in improving symptoms of anxiety and distress including nausea and vomiting in this vulnerable group This research will evaluate the efficacy of virtual reality in managing anxiety nausea and vomiting in cancer patients receiving their first line of chemotherapy and will also measure the quality of life of these patients and evaluate patient and nursing staff satisfaction
Detailed Description:
For cancer patients virtual reality proved more effective than other forms of distraction in relieving anxiety depression and fatigue during chemotherapy Although pain and anxiety in cancer patients are managed proactively this study was designed to measure the quality of life of these patients assess patient and carer satisfaction evaluate the effectiveness of virtual reality in reducing anxiety during the first three sessions of chemotherapy and assess the impact of virtual reality on preventive and acute chemotherapy-induced fatigue nausea and vomiting
This is a clinical study with a therapeutic aim using a non-medicinal interventional prospective multi-centre controlled and randomised technique with two parallel groups It is clinical research involving the human person category 2 involving only minimal risks and constraints The two arms are Arm A study questionnaires with virtual reality VR Arm B study questionnaires without virtual reality standard care SC
A visit will be made during the 3 cycles of chemotherapy during which arm A will be immersed in Virtual Reality with the Healthy Mind VR programme
programme and patients in arm B will receive standard care without hypnotic support
There will also be a pre-inclusion visit 7 days before the first cycle and visits at 3 6 and 9 months after the 3 cycles of chemotherapy
This is a clinical study with a therapeutic aim using a non-medicinal interventional prospective multi-centre controlled and randomised technique with two parallel groups It is clinical research involving the human person category 2 involving only minimal risks and constraints The two arms are Arm A study questionnaires with virtual reality VR Arm B study questionnaires without virtual reality standard care SC
A visit will be made during the 3 cycles of chemotherapy during which arm A will be immersed in Virtual Reality with the Healthy Mind VR programme
programme and patients in arm B will receive standard care without hypnotic support
There will also be a pre-inclusion visit 7 days before the first cycle and visits at 3 6 and 9 months after the 3 cycles of chemotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None