Virtual RealityNCT05275881
Impact of Virtual Reality in Hematology and Oncology During Invasive Procedures in Children, Adolescents and Young Adults, from 7 to Less Than 25 Years Old
A study testing Virtual Reality and Usual Practices in people with Virtual Reality and Pediatrics, run by Poitiers University Hospital at 1 site in France.
Trial summary
This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children and young adults with cancer. Patients age from 7 to under 25 years whose treatement protocols required a lumbure puncture and a chemotherapy by implantable venous access will be… Read more about this study
- Who is it for?
- Ages 7 to 24 years
- Conditions the study is for
- Virtual Reality, Pediatrics, Cancer
- What is being tested?
- Virtual Reality and Usual Practices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2022to 13 Dec 2026
- 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 7 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 7 to strictly under 25
- Follow-ups for hematological or oncological pathology
- With a lumbar puncture or to connection to an implantable chamber
- Patient understanding French
- Consent of parents or guardians with parental authority.
- Child informed and having given his assent
Who cannot join
- Children with cognitive impairment
- Children in absolute emergency situations
- Children with a contraindication to a virtual reality headset (psychiatric pathology, vestibular and proprioceptive disorders, unbalanced epilepsy, impaired vision, hearing aids, claustrophobia, recent lesions of the eyes, face or scalp)
- Children who have already participated in the clinical investigation
- Refusal to participate in the study
- Patients not benefiting from a social security system or not benefiting from it by the intermediary of a third person
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Virtual Reality in Hematology and Oncology for the Management of Pain During Invasive Procedures in Children, Adolescents and Young Adults, 7 to Under 25 Years in a Pilot Study
This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children and young adults with cancer. Patients age from 7 to under 25 years whose treatement protocols required a lumbure puncture and a chemotherapy by implantable venous access will be randomly assigned to virtual reality or treatement as usual (nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine). We expect the same benefit by using VR as usual intervention.
Read the detailed description
Nationally, around 2,150 new cases of cancer are diagnosed per year in children aged 0 to 18. The main locations are leukemia, central system tumors and lymphomas. The onco-pediatrics unit of the Poitiers University Hospital is recruiting around 70 patients per year from 0 to under 18 years old. 1482 invasive procedures have been done in 2019. The diagnostic and therapeutic methods for these children remain aggressive and involve patients in chronic care. They repeatedly undergo painful and anxiety-inducing care. In pediatrics, nitrous oxide is chosen as the first-line choice in these various procedures, but its effectiveness is not always conclusive, due to habituation, and can induce side effects. For some children, it becomes difficult to obtain their consent to care, despite the range of different analgesics offered, and forces prescribers to increase the drugs. Virtual reality (VR) has already been shown to be effective on pain and anxiety in children and adolescents. This devices uses distraction and hypnosis techniques by establishing a state of hypnosedation and mediation through the work of breathing and sophrology. With this study, we expect the same benefit by using VR as usual pratices.
After explaining the treatment protocol, the potentially eligible patient will be informed by the investigator of the possibility of participating in this clinical trial. After checking the eligibility criteria and including the patient, the investigator can randomize the patient in the control group or the experimental group. As part of this study, patients will be followed for 1 month and for each act of lumbar puncture and connection to an implantable chamber.
- Conditions
- Virtual Reality, Pediatrics, Cancer, Pain, Procedural Pain
- Being tested
- Virtual Reality, Usual Practices
- Keywords
- Virtual Reality, Pediatrics, Cancerology, Pain, Invasive Acts
- Medical subject headings
- Neoplasms, Pain, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
In each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the the RV group, The session will be started before the gesture and the patient will wear the helmet throughout the act. In case of pain and / or restlessness, the child will receive analgesics.
Usual PracticesDrug
In each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the control group, the child will receive the usual care: nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality headset Group | Experimental | 30 patients will be included in the virtual reality arm Receives: Device: Virtual Reality |
| Control group with usual practices | Active comparator | 30 patients will be included the usual practices Receives: Drug: Usual Practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of virtual reality compared to usual analgesic practices in pain management during the first lumbar puncture or connection to an implantable chamber of the study.
At the inclusion, the primary endpoint will be to assess pain using the Visual Analogue Scale (VAS) after the first invasive act of lumbar puncture or connection to an implantable chamber.
The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The EVA (Analogue Visual Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain.
The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment:
- 0: no pain
- Between 1 and 3: mild pain
- Between 3 and 5: moderate-intensity pain
- Between 5 and 7: severe pain
- Greater than 7: very intense pain
Measured: up to one day
Secondary outcomes (9)
Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to the implantable chamber
Pain from the VAS after the 1st connection to the implantable chamber:
The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain.
The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment:
- 0: no pain
- Between 1 and 3: mild pain
- Between 3 and 5: moderate-intensity pain
- Between 5 and 7: severe pain
- Greater than 7: very intense pain
Measured: up to one month
Comparison, between the control group and the group supported with virtual reality: Child's anxiety using the Frankl scale
The Frankl scale, is a scale of hetero-evaluation of anxiety. It will be performed by the caregiver before the invasive procedure (lumbar puncture and connection to an implantable chamber). It is suitable for children from 7 to under 25 years old and is easy to score:
- 0: Definitely negative behavior; refuses treatment, shouts forcefully, opposes/cares,
- 1: Negative behavior: unwilling to accept care; unwilling to accept care. Some signs of opposition exist but not necessarily declared (sullen air, scowling),
- 2: Positive behaviour; accepts treatment with reservation. He is cautious but follows the instructions of the practitioner/caregiver
- 3: Definitely positive behavior; good relations/practitioner/caregiver, interested in treatment. He laughs often and seems to enjoy the visit/care.
Measured: up to one month
Comparison, between the control group and the group supported with virtual reality:The type and amount of analgesics consumed during the invasive act (lumbar puncture and / or connection to an implantable chamber)
The type of associated analgesics, the dosage will be collected through the patient's medical record
Measured: up to one month
Comparison, between the control group and the group supported with virtual reality: Heart rate
Heart rate (min <40 B/min - max >200 B/min), from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)
Measured: up to one month
Comparison, between the control group and the group supported with virtual reality:oxygen saturation
oxygen saturation (min <90% - max >100%) from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)
Measured: up to one month
Comparison, between the control group and the group supported with virtual reality: Respiratory rate
Respiratory rate (min <10 - max > 50) from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)
Measured: up to one month
Comparison, between the control group and the group supported with virtual reality: Tolerance
Tolerance, in number of episodes of confusion, agitation, dizziness, nausea, vomiting, headache, hallucinations and temporary amnesia during the performance of the invasive act and within 2 hours of post-act monitoring for a lumbar puncture and 30 minutes for a connection to an implantable chamber
Measured: up to one month
Comparison, between the control group and the group supported with virtual reality: Pain after each act from the VAS
A patient may have several consecutive invasive acts. The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7:
- 0: no pain
- Between 1 and 3: mild pain
- Between 3 and 5: moderate-intensity pain
- Between 5 and 7: severe pain
- Greater than 7: very intense pain
Measured: up to one month
Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to an implantable chamber
Pain from the VAS after the 1st connection to an implantable chamber the :
The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain.
The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment:
- 0: no pain
- Between 1 and 3: mild pain
- Between 3 and 5: moderate-intensity pain
- Between 5 and 7: severe pain
- Greater than 7: very intense pain
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start13 Oct 2022
- Primary completion13 Nov 2026 (estimated)
- Study completion13 Dec 2026 (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 Poitiers University HospitalThe 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
- This is an exploratory interventional, comparative, single-center, randomized research into 2 parallel groups. The study will compare the use of virtual reality versus usual practices for two iterative and painful acts: lumbar puncture and connection to an implantable chamber.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amandine AF FERNANDES, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275881
- Sponsor's protocol ID
- HOPPIVR
- Status last verified
- Dec 2024
- First submitted
- 10 Feb 2022
- Last updated
- 16 Dec 2024
- 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality in Hematology and Oncology for the Management of Pain During Invasive Procedures in Children, Adolescents and Young Adults, 7 to Under 25 Years in a Pilot Study
- ClinicalTrials.gov ID
- NCT05275881
- Acronym / sponsor ID
- HOPPIVR
- Conditions
- Virtual Reality, Pediatrics, Cancer, Pain, Procedural Pain
- Keywords
- Virtual Reality, Pediatrics, Cancerology, Pain, Invasive Acts
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 13 Dec 2026 (estimated)
- First posted
- 11 Mar 2022 (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.
This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children and young adults with cancer. Patients age from 7 to under 25 years whose treatement protocols required a lumbure puncture and a chemotherapy by implantable venous access will be randomly assigned to virtual reality or treatement as usual (nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine). We expect the same benefit by using VR as usual intervention.
Detailed description
Nationally, around 2,150 new cases of cancer are diagnosed per year in children aged 0 to 18. The main locations are leukemia, central system tumors and lymphomas. The onco-pediatrics unit of the Poitiers University Hospital is recruiting around 70 patients per year from 0 to under 18 years old. 1482 invasive procedures have been done in 2019. The diagnostic and therapeutic methods for these children remain aggressive and involve patients in chronic care. They repeatedly undergo painful and anxiety-inducing care. In pediatrics, nitrous oxide is chosen as the first-line choice in these various procedures, but its effectiveness is not always conclusive, due to habituation, and can induce side effects. For some children, it becomes difficult to obtain their consent to care, despite the range of different analgesics offered, and forces prescribers to increase the drugs. Virtual reality (VR) has already been shown to be effective on pain and anxiety in children and adolescents. This devices uses distraction and hypnosis techniques by establishing a state of hypnosedation and mediation through the work of breathing and sophrology. With this study, we expect the same benefit by using VR as usual pratices.
After explaining the treatment protocol, the potentially eligible patient will be informed by the investigator of the possibility of participating in this clinical trial. After checking the eligibility criteria and including the patient, the investigator can randomize the patient in the control group or the experimental group. As part of this study, patients will be followed for 1 month and for each act of lumbar puncture and connection to an implantable chamber.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an exploratory interventional, comparative, single-center, randomized research into 2 parallel groups. The study will compare the use of virtual reality versus usual practices for two iterative and painful acts: lumbar puncture and connection to an implantable chamber.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality headset Group | Experimental | Device: Virtual Reality30 patients will be included in the virtual reality arm |
| Control group with usual practices | Active comparator | Drug: Usual Practices30 patients will be included the usual practices |
Who may qualify
- Ages
- 7 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients aged 7 to strictly under 25
- Follow-ups for hematological or oncological pathology
- With a lumbar puncture or to connection to an implantable chamber
- Patient understanding French
- Consent of parents or guardians with parental authority.
Key exclusion criteria (6 listed)
- Children with cognitive impairment
- Children in absolute emergency situations
- Children with a contraindication to a virtual reality headset (psychiatric pathology, vestibular and proprioceptive disorders, unbalanced epilepsy, impaired vision, hearing aids, claustrophobia, recent lesions of the eyes, face or scalp)
- Children who have already participated in the clinical investigation
- Refusal to participate in the study
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 |
|---|---|---|
| Virtual RealityIn each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the the RV group, The session will be started before the gesture and the patient will wear the helmet throughout the act. In case of pain and / or restlessness, the child will receive analgesics. | Device | Virtual Reality headset Group |
| Usual PracticesIn each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the control group, the child will receive the usual care: nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine | Drug | Control group with usual practices |
Primary outcome
To assess the effectiveness of virtual reality compared to usual analgesic practices in pain management during the first lumbar puncture or connection to an implantable chamber of the study.
Time frame: up to one day
At the inclusion, the primary endpoint will be to assess pain using the Visual Analogue Scale (VAS) after the first invasive act of lumbar puncture or connection to an implantable chamber. The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The EVA (Analogue Visual Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain. The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment: * 0: no pain * Between 1 and 3: mild pain * Between 3 and 5: moderate-intensity pain * Between 5 and 7: severe pain * Greater than 7: very intense pain
9 secondary outcomes
Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to the implantable chamber
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Child's anxiety using the Frankl scale
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality:The type and amount of analgesics consumed during the invasive act (lumbar puncture and / or connection to an implantable chamber)
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Heart rate
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality:oxygen saturation
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Respiratory rate
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Tolerance
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Pain after each act from the VAS
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to an implantable chamber
Time frame: up to one month
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 16 Dec 2024.
- 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.
Amandine AF FERNANDES principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Usual Practices in people with Virtual Reality and Pediatrics, run by Poitiers University Hospital at 1 site 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 6 inclusion and 6 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Amandine AF FERNANDES (+33549444578, amandine.fernandes@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of virtual reality compared to usual analgesic practices in pain management during the first lumbar puncture or connection to an implantable chamber of the study. (time frame: up to one day). 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 16 Dec 2024.