Impact of Virtual Reality on the Quality of Life of Oncology Patients (VIRONSCARE)

Central Hospital Saint Quentin

Status

Enrolling

Conditions

Cancer

Treatments

Other: Measurement of depressive state

Other: measuring fatigue levels

Other: Measurement of anxiety and pain

Other: Measure the improvement in quality of life

Other: Measure the level of satisfaction of patients and nursing staff

Other: measurement of acute nausea and vomiting

Study type

Interventional

Funder types

Other

Identifiers

NCT06485869

2023-A01543-42

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Chemotherapy-naive patient
Patient with first-line indication for intravenous cyclic chemotherapy
Affiliated to a social security system
Having received full information on the organization of the research and having given free, informed and written consent signed by the participant and the investigator
Patient understands French or English
Expected duration of chemotherapy session for the first 3 cycles greater than 30 minutes

exclusion criteria :

Patient with communication disorders preventing informed consent
Patient under legal protection (guardianship, curatorship, safeguard of justice)
Patients suffering from epilepsy
Severe visual or hearing impairment preventing use of headphones
Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia.
Patients with infections or facial wounds
Patients with severe claustrophobia
Patients with pacemakers
Patients with known cognitive or learning problems,
Patients with brain tumors or metastases,
Patients suffering from motion sickness
Expected duration of chemotherapy session for the first 3 cycles of 30 minutes or less.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

With virtual reality session

Experimental group

Description:

Arm A patients will benefit from a 20-minute virtual reality session per chemotherapy session, for the first 3 cycles, with each session lasting more than 30 minutes.

Treatment: