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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02154-41 | Other Identifier | ANSM |
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Main objective:
Evaluate the effectiveness of the repeated use of interactive or hypnotic virtual reality compared to standard treatment, on pain, during each needle placement on PAC for 3 months on children or adolescents (6 to 16 years old) with acute leukemia
Hypothesis:
Repeated use over 3 months of hypnotic or interactive virtual reality provides more benefits in terms of :
Children and adolescents with acute leukemia frequently have anxiety-provoking and painful care in the management of their disease. As soon as the diagnosis is announced, the installation of a central line is recommended to allow the administration of chemotherapy treatments, parenteral nutrition, and blood tests. The implantable port (IP) is more often used than the central catheter. It allows the injection of drugs directly into the implantable port, through the skin using a specific needle whose caliber can be variable. This treatment, which can be repeated weekly, causes pain and anxiety for children. The use of skin anesthetic patches (EMLA®) is recommended to limit pain during needle installation. According to the literature, this system limits the pain associated with needle injections but does not reduce children's anxiety about this upcoming treatment. The repetition of the gesture, often for several months, is a source of discomfort and pain that only increases over time. A memorization of pain increases the apprehension of care by the child, his parents and can also create difficult care conditions for the caregiver. These children receive multiple treatments, which is why a non-drug intervention is recommended for the management of pain and anxiety. Standard distraction (e.g.: speech) is recommended but it is often insufficient. This is why the use of interactive or hypnotic virtual reality (VR) could improve the care of these children and in particular reduce anxiety and fear. The immersion of the child in a three-dimensional environment with sound and visual stimulation potentiates the diversion of his attention. Thus, it seems necessary to evaluate the impact of interactive or hypnotic virtual reality on pain and anxiety during repeated painful care in children with acute leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard method | Active Comparator | In this standard method, before the treatment, the procedure of inserting the needle into the implantable port is explained to the child. The patient is comfortably installed and the treatment start using the standard method which consist on distracting the patient by singing, story telling, talking etc.. Use of local anesthesic cream and +/- anxiolytic gas |
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| Interactive virtual reality | Active Comparator | Before the treatment, the caregiver explains the procedure of inserting the needle into the implantable port. A general explanation is given on the VR device (how the headphones and headsets are placed), presentation of the virtual worlds to choose from, description of the course of the session (virtual travel is guided by a voice). For the interactive virtual reality, the mode of operation will be explained as the actions are validated using the eyes. The patient is then installed comfortably. The caregiver helps the child to put on the headphones and headset correctly. Before starting the care procedure, the caregiver will wait about 5 minutes after the start of the viewing to make sure the child is completely immersed in the virtual reality. The software is turned off about 3 minutes after the end of the care procedure. Use of local anesthesic cream. |
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| Hypnotic virtual reality | Active Comparator | Before the treatment, the caregiver explains the procedure of inserting the needle into the implantable port to the child. A general explanation is given on the VR device (how the headphones and headsets are placed), presentation of the virtual worlds to choose from, description of the course of the session (virtual travel is guided by a voice). The patient is then installed comfortably. The caregiver helps the child to put on the headphones and headset correctly. Before starting the care procedure, the caregiver will wait about 5 minutes after the start of the viewing to make sure the child is completely immersed in the virtual reality. The software is turned off about 3 minutes after the end of the care procedure. Use of local anesthesic cream. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnotic Virtual reality | Device | Hypnotic Virtual reality mask Deepsen® with age-appropriate software Birdy® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Children's pain self-evaluation | Self-evaluation of children's pain with the visual analog scale in vertical position. Quote from 0 to 10 with 10 being the worst score. | 15 minutes after the care |
| Measure | Description | Time Frame |
|---|---|---|
| Children's fear evaluation | Children's fear evaluation by the nurse with the visual analog scale from 0 to 10 with 10 being the worst score | 15 minutes before the care and right after the procedure |
| Children's heart rate measurement |
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Inclusion Criteria:
Exclusion Criteria:
Children from 6 to 16:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | +33473754963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Alexandra USCLADE | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Recruiting | Bordeaux | 33000 | France |
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Randomized, controlled, open-label, three arms parallel, multicenter therapeutic trial
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| Interactive virtual reality | Device | Interactive virtual reality mask Deepsen® with age-appropriate software Birdy® |
|
| Standard method | Other | Use of local anesthesic cream + Nurse and/or parents distraction +/- anxioloytic gas |
|
Heart rate mesure using a digital sensor
| 15 minutes before the care and right after the procedure |
| Evaluation of the care | Satisfaction of the care given to the child filled out by nurses, parents and child using a questionnaire. Score going fro 1 to 3 with 3 being the best score = very satisfied | After each care from the date of randomization and assessed during 3 months |
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
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| Assistance Publique - Hôpitaux de Marseille | Recruiting | Marseille | 13005 | France |
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| CHU de Toulouse | Recruiting | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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