Clinical Trials Logo

Clinical Trial Summary

For a young patient, the conditions of proton therapy treatment can be stressful. Adjusting the environment can be a source of avoiding this physical and psychological discomfort impacting the quality of treatment. A fixed, long, uncomfortable position is the main cause of stress, already present due to the cancerous therapeutic course. It extends the positioning time. For the patient and the optimization of his treatment, solutions must be sought. Relaxation in virtual reality is efficient, simple and non-medicinal and could reduce stress in children and allow irradiation in very good conditions. We will assess the effectiveness of the virtual reality session using objective (placement time, helmet tolerance) and subjective (perceived anxiety via a dedicated questionnaire) criteria. This is the first pediatric virtual reality study, supported by the French Group of Pediatric Radiotherapists, to reduce anxiety in radiotherapy. Multiple benefits from this pilot study are expected, such as improved reception conditions, treatment parameters and better acceptance of proton therapy sessions.


Clinical Trial Description

The treatment of certain pediatric cancers requires irradiation. These treatments are stressful in children because it is necessary to keep a fixed position that is often uncomfortable. The more the stress increases, the longer the positioning, which again generates stress making the treatment position more and more uncomfortable. This irradiation can be carried out by various conventional techniques, tomotherapy, proton therapy. In all cases, the precise positioning, essential for the successful completion of the treatment, under the treatment machine is an iterative process, requiring long and tedious checks. This positioning step on the treatment table takes about 15 minutes, but depending on the technical difficulty can be extended up to 45 minutes in the most complex cases and depending on the patient's apprehension. This positioning is then checked by placement verification images. At the Antoine LACASSAGNE Center, the investigators have a new generation proton therapy device. This device allows radiotherapy doses to be delivered extremely precisely, subject to very rigorous positioning, and is therefore particularly suitable for pediatric treatment by protecting organs near the radiation. In addition, proton therapy requires longer sessions than conventional radiotherapy; which generates even more anxiety for the children for whom it is the treatment of choice. Non-drug solutions to reduce this stress are therefore necessary to allow the irradiation to be carried out under optimal conditions in order to ensure the effectiveness and safety of the treatment. In this context, virtual reality (VR) headsets, using relaxation techniques in virtual reality or digital sedation, are presented as a simple solution to reduce the anxiety of children regarding the treatment and would therefore be tested mainly on this modality. To allow us to assess the effectiveness of this technique on anxiety, the investigators will therefore measure the positioning time necessary before carrying out a treatment session and its reduction via its impact on perceived anxiety thanks to a dedicated questionnaire. The strength of our study is that it uses simple and reproductive measurement systems such as the measurement of placement time and a validated anxiety scale during Marie POURCHET's science thesis. This is the easy EVAN (Anxiety Assessment) scale adapted to several age groups and developed in pediatric wards. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04934293
Study type Interventional
Source Centre Antoine Lacassagne
Contact Anne GARCIA
Phone 04-92-03-19-44
Email Anne.GARCIA@nice.unicancer.fr
Status Recruiting
Phase N/A
Start date August 26, 2021
Completion date November 21, 2024

See also
  Status Clinical Trial Phase
Completed NCT05720819 - Biofeedback-VR for Treatment of Chronic Migraine N/A
Recruiting NCT05547152 - Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis N/A
Recruiting NCT05528497 - Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia N/A
Recruiting NCT05378581 - Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children N/A
Completed NCT04091659 - Use of Virtual Reality for Overdose Management Educational Trainings N/A
Completed NCT04880486 - Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Not yet recruiting NCT05982457 - The Effect of Virtual Reality Application in Cervical Dilatation and Effacement Teaching N/A
Completed NCT06061588 - "Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches" N/A
Completed NCT06112600 - The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination N/A
Active, not recruiting NCT04532866 - Brain Changes in Response to Long-Duration Isolation and Confinement N/A
Completed NCT05604924 - Virtual Reality Training Simulator for Cesarean Section N/A
Recruiting NCT04736888 - Effectiveness of Extended Reality CPR Training Methods N/A
Not yet recruiting NCT05941390 - Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures N/A
Completed NCT05961033 - The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis
Recruiting NCT04630184 - A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity N/A
Terminated NCT03665233 - Virtual Reality for Post Operative Pain Management After Total Knee Arthroplasty N/A
Recruiting NCT03698526 - Virtual Reality for Symptoms Control in Palliative Care N/A
Suspended NCT03715400 - Mobile Virtual Positive Experiences for Anhedonia N/A
Completed NCT03208400 - Virtual Reality Exposure in Spider Phobia N/A
Completed NCT05078762 - Immersive Virtual Reality in Simulation-based Bronchoscopy Training N/A