Impact of Virtual Reality on the Quality of Life of Oncology Patients
NCT ID: NCT06485869
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-11-01
2026-08-29
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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With virtual reality session
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.
Measure the improvement in quality of life
Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire
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.
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)
Measurement of depressive state
Depressive State is measured by HAD score
measuring fatigue levels
Fatigue levels is measured by Visual Analogue Scale (VAS).
measurement of acute nausea and vomiting
acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT)
Without virtual reality session
Patients in arm B will receive conventional care without hypnotic support.
Measure the improvement in quality of life
Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire
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.
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)
Measurement of depressive state
Depressive State is measured by HAD score
measuring fatigue levels
Fatigue levels is measured by Visual Analogue Scale (VAS).
measurement of acute nausea and vomiting
acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT)
Interventions
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Measure the improvement in quality of life
Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire
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.
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)
Measurement of depressive state
Depressive State is measured by HAD score
measuring fatigue levels
Fatigue levels is measured by Visual Analogue Scale (VAS).
measurement of acute nausea and vomiting
acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Central Hospital Saint Quentin
OTHER_GOV
Responsible Party
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Principal Investigators
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Frédérique Mm Roussel
Role: PRINCIPAL_INVESTIGATOR
CH SAINT-QUENTIN
Locations
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Centre Hospitalier de Chauny
Chauny, , France
Centre Hospitalier de Saint Quentin
Saint-Quentin, , France
Countries
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Central Contacts
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Facility Contacts
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Frédérique DR Roussel
Role: primary
References
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Related Links
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The prevalence of long-term symptoms of depression and anxiety after breast cancer treatment: A systematic review
Projection de l'incidence et de la mortalité par cancer en France métropolitaine en 2017
Other Identifiers
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2023-A01543-42
Identifier Type: -
Identifier Source: org_study_id
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