Virtual RealityLEAVENCT06697275
Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
A study testing Hypnotic Virtual reality, Interactive virtual reality and Standard method in people with Virtual Reality and Children and Adolescents, run by University Hospital, Clermont-Ferrand at 4 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Virtual Reality, Children and Adolescents, Acute Leukemia
- What is being tested?
- Hypnotic Virtual reality, Interactive virtual reality and Standard method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Nov 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 6 to 16 years old suffering from leukemia requiring needle insertion into an implantable port and having a life expectancy greater than or equal to 3 months
- Subjects and their parents who have been informed of the study and having expressed their informed consent
- Children without contraindications to the use of MEOPA® :
- Patient requiring 100% oxygen ventilation
- Intracranial hypertension
- Any alteration in the state of consciousness preventing the patient\'s cooperation
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- Children without contraindication to the use of the virtual reality mask:
- Epilepsy
- Psychiatric illness
- Children and parents able to use the self-assessment scales proposed in the study
- Enrolment in the Social Security system
Who cannot join
- Children from 6 to 16:
- Having a modification of pain\'s integration (spina bifida for example)
- Requiring contact isolation (conjunctivitis, contagious skin condition, etc.)
- With a history of seizures
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Clémentine Zannettacci
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Emmanuelle Labraise
- Recruiting
Assistance Publique - Hôpitaux de Marseille
Marseille, 13005
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Julie Soler
- Recruiting
CHU de Toulouse
Toulouse, 31059
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Silvi Bador
About this study
Official title: Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia: Randomized Multicenter Trial
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 :
- pain management
- anxiety of the child and his parents
- satisfaction of the child's care, of his parents and of the caregivers compared to the standard method when inserting a needle into an implantable port in the pediatric oncology department or day hospital.
Read the detailed description
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.
- Being tested
- Hypnotic Virtual reality, Interactive virtual reality, Standard method
- Keywords
- acute leukemia, virtual reality mask, children and adolescents from 6 to 16
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic Virtual realityDevice
Hypnotic Virtual reality mask Deepsen® with age-appropriate software Birdy®
Interactive virtual realityDevice
Interactive virtual reality mask Deepsen® with age-appropriate software Birdy®
Standard methodOther
Use of local anesthesic cream + Nurse and/or parents distraction +/- anxioloytic gas
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Standard method |
| 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. Receives: Device: Interactive virtual reality |
| 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. Receives: Device: Hypnotic Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes after the care
Secondary outcomes (3)
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
Measured: 15 minutes before the care and right after the procedure
Children's heart rate measurement
Heart rate mesure using a digital sensor
Measured: 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
Measured: After each care from the date of randomization and assessed during 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start15 Nov 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, open-label, three arms parallel, multicenter therapeutic trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra USCLADE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697275
- Sponsor's protocol ID
- PHRIP-2022-USCLADE
- Other IDs
- 2023-A02154-41
- Acronym
- LEAVE
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia: Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT06697275
- Acronym / sponsor ID
- LEAVE / PHRIP-2022-USCLADE
- Keywords
- acute leukemia, virtual reality mask, children and adolescents from 6 to 16
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- pain management
- anxiety of the child and his parents
- satisfaction of the child's care, of his parents and of the caregivers compared to the standard method when inserting a needle into an implantable port in the pediatric oncology department or day hospital.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, controlled, open-label, three arms parallel, multicenter therapeutic trial
| Arm | Type | Receives |
|---|---|---|
| Standard method | Active comparator | Other: Standard methodIn 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 |
| Interactive virtual reality | Active comparator | Device: Interactive virtual realityBefore 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. |
| Hypnotic virtual reality | Active comparator | Device: Hypnotic Virtual realityBefore 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Children from 6 to 16 years old suffering from leukemia requiring needle insertion into an implantable port and having a life expectancy greater than or equal to 3 months
- Subjects and their parents who have been informed of the study and having expressed their informed consent
- Children without contraindications to the use of MEOPA® :
- Patient requiring 100% oxygen ventilation
- Intracranial hypertension
Key exclusion criteria (4 listed)
- Having a modification of pain\'s integration (spina bifida for example)
- Requiring contact isolation (conjunctivitis, contagious skin condition, etc.)
- With a history of seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnotic Virtual realityHypnotic Virtual reality mask Deepsen® with age-appropriate software Birdy® | Device | Hypnotic virtual reality |
| Interactive virtual realityInteractive virtual reality mask Deepsen® with age-appropriate software Birdy® | Device | Interactive virtual reality |
| Standard methodUse of local anesthesic cream + Nurse and/or parents distraction +/- anxioloytic gas | Other | Standard method |
Primary outcome
Children's pain self-evaluation
Time frame: 15 minutes after the care
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.
3 secondary outcomes
Children's fear evaluation
Time frame: 15 minutes before the care and right after the procedure
Children's heart rate measurement
Time frame: 15 minutes before the care and right after the procedure
Evaluation of the care
Time frame: After each care from the date of randomization and assessed during 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra USCLADE principal investigator
University Hospital, Clermont-Ferrand
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic Virtual reality, Interactive virtual reality and Standard method in people with Virtual Reality and Children and Adolescents, run by University Hospital, Clermont-Ferrand at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's pain self-evaluation (time frame: 15 minutes after the care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.