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Trial Title:
Impact of Virtual Reality on the Quality of Life of Oncology Patients
NCT ID:
NCT06485869
Condition:
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
non-randomized parallel two-arm comparative study with a group without virtual reality
sessions and a group with virtual reality sessions
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Measure the improvement in quality of life
Description:
Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire
Arm group label:
With virtual reality session
Arm group label:
Without virtual reality session
Intervention type:
Other
Intervention name:
Measure the level of satisfaction of patients and nursing staff
Description:
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.
Arm group label:
With virtual reality session
Arm group label:
Without virtual reality session
Intervention type:
Other
Intervention name:
Measurement of anxiety and pain
Description:
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)
Arm group label:
With virtual reality session
Arm group label:
Without virtual reality session
Intervention type:
Other
Intervention name:
Measurement of depressive state
Description:
Depressive State is measured by HAD score
Arm group label:
With virtual reality session
Arm group label:
Without virtual reality session
Intervention type:
Other
Intervention name:
measuring fatigue levels
Description:
Fatigue levels is measured by Visual Analogue Scale (VAS).
Arm group label:
With virtual reality session
Arm group label:
Without virtual reality session
Intervention type:
Other
Intervention name:
measurement of acute nausea and vomiting
Description:
acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT)
Arm group label:
With virtual reality session
Arm group label:
Without virtual reality session
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier de Chauny
Address:
City:
Chauny
Zip:
02300
Country:
France
Status:
Recruiting
Contact:
Last name:
Jerome Dr Cherry
Phone:
06 08 22 95 99
Email:
jerome.chery@ch-chauny.fr
Facility:
Name:
Centre Hospitalier de Saint Quentin
Address:
City:
Saint-Quentin
Zip:
02100
Country:
France
Status:
Recruiting
Contact:
Last name:
Frédérique DR Roussel
Start date:
November 1, 2023
Completion date:
August 29, 2026
Lead sponsor:
Agency:
Central Hospital Saint Quentin
Agency class:
Other
Source:
Central Hospital Saint Quentin
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06485869
https://doi.org/10.1016/j.maturitas.2015.04.010
https://www.santepubliquefrance.fr/docs/projection-de-l-incidence-et-de-la-mortalite-par-cancer-en-france-metropolitaine-en-2017
