NCT06485869

Impact of Virtual Reality on the Quality of Life of Oncology Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Central Hospital Saint Quentin · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	Measure the improvement in quality of life	Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire
OTHER	Measure the level of satisfaction of patients and nursing staff	Patient satisfaction is measured using a five-point scale ranging from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate higher levels of satisfaction.
OTHER	Measurement of anxiety and pain	Anxiety and pain is measured by Visual Analogue Scale (VAS). This measurement is complemented by physiological responses to anxiety, measured by heart rate and mean arterial blood pressure (HR and BP)
OTHER	Measurement of depressive state	Depressive State is measured by HAD score
OTHER	measuring fatigue levels	Fatigue levels is measured by Visual Analogue Scale (VAS).
OTHER	measurement of acute nausea and vomiting	acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT)

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-08-29
• Completion: 2026-08-29
• First posted: 2024-07-03
• Last updated: 2024-07-03

Locations

2 sites across 1 country: France