Impact of Virtual Reality on the Quality of Life of Oncology Patients
NCT Number: NCT06485869
Acronym: VIRONSCARE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: OTHER: Measure the improvement in quality of life|OTHER: Measure the level of satisfaction of patients and nursing staff|OTHER: Measurement of anxiety and pain|OTHER: Measurement of depressive state|OTHER: measuring fatigue levels|OTHER: measurement of acute nausea and vomiting
Sponsor: Central Hospital Saint Quentin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-11-01
Completion Date: 2026-08-29
Locations: Centre Hospitalier de Chauny, Chauny, 02300, France|Centre Hospitalier de Saint Quentin, Saint-Quentin, 02100, France

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

Primary Outcome Measures: QLQ-C30, Measurement of the quality of life observed in patients. The QLQ-C30 questionnaire consists of 30 questions on the patient's state of physical and mental health. There are 28 questions with scores ranging from 1 = not at all to 4= very much and two questions with scores ranging from 1= very poor to 7= excellent., at the start of cycle 1 (each cycle is 28 days); 3,6,9 months post chemo, at the beginning of the 3rd month post chemo, at the beginning of the 6th month post chemo and at the beginning of the 9th month post chemo|Measuring patient and nurse satisfaction with the chemotherapy procedure, Use of a patient questionnaire with a 10-point scale assessed on a five-point scale ranging from 1=strongly disagree disagree to 5 = strongly agree, after the first chemotherapy session on day 1 of cycle 1 and 3 (each cycle lasts 28 days)|MAT, Assessment of acute nausea and vomiting in patients induced by chemotherapy. 4 questions are used to assess nausea and vomiting 24 hours after chemotherapy and these 4 questions are again used to assess late nausea and vomiting.

There are 2 questions with a yes or no choice, 1 question with a numerical answer and 1 question with a 10-point numerical scale with 0= none and 10= maximum difficulty., after the first chemotherapy session on day 1 of cycle 2 and 3 (each cycle lasts 28 days)
Secondary Outcome Measures: VAS Score, Measures patients' anxiety and pain levels, as well as their fatigue levels. This questionnaire consists of 4 questions on pain levels, anxiety, fatigue and satisfaction with treatment. It is administered before and after chemotherapy.

A 10-point numerical scale is used, with 0= the minimum and 10 =the maximum., Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).|Heart rate, Measurement of heart rate in bpm. To assess the patient's level of anxiety and pain. Use of a multiparametric monitor. It will be collected before and after virtual reality., Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).|Blood pressure, Measurement of blood pressure in mmHg. To assess the patient's level of anxiety and pain. Use of a multiparametric monitor. It will be collected before and after virtual reality., Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).|HAD Score, Assessment of the patient's state of depression and anxiety. There are 14 questions with scores ranging from 0 to 3 and different answer choices depending on the type of question., Before the start of the first chemotherapy session on day 1 of cycle 1 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1 and 2 (each cycle is 28 days).