Hematologic MalignancyVIRTUOSONCT05042479
Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.
A study testing Usual distraction and pain prevention techniques., Virtual reality and Choice between usual distraction or virtual reality in people with Hematologic Malignancy and Hematologic Non Malignancy, run by Nantes University Hospital at 1 site in France.
Trial summary
Medical procedures can be a very frightening experience for children. It is known that children who received painful medical procedures can develop a higher sensitivity of pain during their following experiences. During their treatments for malignant diseases, children are exposed to a lot of painful procedures (eg. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Hematologic Malignancy, Hematologic Non Malignancy, Solid Tumor, Childhood
- What is being tested?
- Usual distraction and pain prevention techniques., Virtual reality and Choice between usual distraction or virtual reality
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2022to 24 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Quantitative component:
- Child aged 7 to 18 years
- Child followed in pediatric onco-hematology in the context of hematological malignancy or non malignant hematology or solid tumor management.
- Child who has already experienced a potentially painful care procedure before entry the study
- Child who will have the same potentially painful care procedure (Hüber needle placement or lumbar puncture) on three occasions during the course of their care.
- Child with consent.
Show all 10Show fewer
- Child whose parental authority holders have given their consent to participate to the study.
- Qualitative component:
- Professional who used both care-induced pain prevention techniques and agreed to be interviewed.
- A parent or guardian.
Who cannot join
- Child who refuse to use this distraction technique (VR).
- Child who refuse to not use MEOPA during VR.
- Child who hasn't experienced the potentially painful care procedure that will be done during the study at least once before inclusion
- Child who does not speak French and whose parents do not speak French
Trial locations and contacts
1 site in 1 country.
About this study
Medical procedures can be a very frightening experience for children. It is known that children who received painful medical procedures can develop a higher sensitivity of pain during their following experiences.
During their treatments for malignant diseases, children are exposed to a lot of painful procedures (eg. needle insertion, lumbar punction, myelogram, etc…)
Read more
Therefore, medical societies propose the use of interventions like distraction techniques for pain management in complement of pharmacological treatment.
In addition, the repetitions of painful procedures and ineffective prevention of pain can create care phobia.
Within this context, immersive and participative virtual reality (VR) could be an innovative distraction technique for pain management among children undergoing medical procedures.
Attention Pain Theory can explain how virtual reality can reduce the perception of pain. Attention is required to feel pain. When the patient is focused on another subject like an immersive virtual environment, his brain is less available to treat information like painful stimulus from care procedures.
The investigators hypothesis is that VR can reduce procedural-related pain and can decrease fear during the following procedures.
Results of previous studies are varied : some showed a non-significant reduction of patient's procedural pain despite the use of VR, whereas others concluded to a decrease of pain. The question of the benefit of VR for the patients who are exposed to repeated painful procedures remains still unclear, especially with patients who are likely to feel chronic pain or many pain-related exposures.
The aim of this study is to evaluate the non-inferiority of virtual reality as a distraction technique for pain management in children and adolescents with onco-hematological diseases, undergoing painful procedures, compared to standard of care.
Read the detailed description
VIRTUOSO is a study that aims to evaluate the impact of using a virtual reality headset to prevent care-induced pain in pediatric oncology. This study plans to include 34 patients. It is a single-center, non-inferiority, controlled, with cross-over study.
Efficiency of VR will be evaluated for each patient across 3 potentially painful care-procedures :
For the first treatment, the child will benefit usual distraction and pain prevention techniques.
For the 2nd treatment, the child will use a VR headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age.
For the 3rd treatment, the child will choose his/her favorite technique.
The virtual reality headset is an Occulus Quest headset, composed of 2 integrated earphones. It is adapted to the environment and can be used sitting or standing.
Usual pharmacological techniques for pain prevention will be maintained as per local practice.
All concomitant treatments are authorized except the use of oxygen-nitrous oxide mixtures.
The duration of this study is approximately 20 months. Inclusion will be for 10 months, patient follow-up for 6 months. Data analysis will be performed during 4 months.
During each treatment, if the child wishes to stop VR, the helmet will be removed and the usual techniques will be offered.
After each procedure, a self-assessment of the pain will be done immediately, using VAS.
At the end of the third treatment, a short questionnaire will be proposed to the child in order to collect the reasons for his choice. Another questionnaire will also be proposed to the parent present during the care.
A qualitative component will explore the social representations of the parents. A range of semi-directive interviews will be conducted with 6 families by a trained professional under the supervision of the methodologist.
- Being tested
- Usual distraction and pain prevention techniques., Virtual reality, Choice between usual distraction or virtual reality
- Keywords
- Pediatric, Pediatric oncology, Pain, Virtual reality, Nurse
- Medical subject headings
- Hematologic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual distraction and pain prevention techniques.Other
For the first painful procedure, the child will benefit usual distraction and pain prevention techniques.Pain prevention and management techniques commonly used in the conduct of care:
- Application of a patch or anaesthetic cream 1 hour before the treatment
- Vigilant sedation using a premedication for lumbar punctures: Midazolam /Nalbuphine/Hydroxyzine/Morphine.
- Apart from care using VR, MEOPA can be given to the child for all assessed care on prescription.
- Apart from care using VR, the usual distraction techniques are left to the patient's choice (electronic tablet, smartphone, games, songs...)
- The presence of the parents
Virtual realityOther
For the 2nd painful procedure, the child will use a VR (virtual reality) headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age.
Choice between usual distraction or virtual realityOther
For the 3rd painful procedure, the child will choose his/her favorite technique between :
Usual distraction and pain prevention techniques or virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment then virtual reality then choice between the two | Experimental | Efficiency of VR will be evaluated for each patient across 3 potentially painful care-procedures :
For the first treatment, the child will benefit usual distraction and pain prevention techniques.
For the 2nd, the child will use a VR headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age and parental agreement.
For the 3rd treatment, the child will choose his/her favorite technique. Receives: Other: Usual distraction and pain prevention techniques.; Other: Virtual reality; Other: Choice between usual distraction or virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level measured by VAS (self-evaluation) during the first care using standard treatment.
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Measured: Immediately after the first care.
Pain level measured by VAS (self-evaluation) during the second care using virtual reality
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Measured: Immediately after the second care .
Pain level measured by VAS (self-evaluation) during the third care using virtual reality or standard treatment
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Measured: Immediately after the third care .
Secondary outcomes (6)
Percentage of children who choose VR in the 3rd care
Patient preference between VR and usual pain prevention technique for the same care.
The difference between the pain level measured on a VAS with the use of VR and the pain level with the usual technique.
VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Measured: Immediately after the 3rd intervention.
Patient questionnaire
Analysis of the answers to the patient questionnaire after treatment n°3. Description of the reasons for selecting the preferred technique.
Measured: Immediately after the 3rd intervention.
Side effects to the use of VR
Record of side effects reported in the e-CRF. Description of the potential side effects to the use of VR in care.
Measured: During each intervention with virtual reality (care 2 and care 3 if VR is chosen). Up to 6 months.
Ethnographic approach to caregivers' experiences after using the VR headset.
Direct observation of the care unit. Understand the obstacles and levers for professionals to implement a new pain prevention device during care.
Measured: Through study completion - up to 20 months.
parent questionnaire.
Analysis of the responses to the parent questionnaire. Understand parents' experience of care when implementing a new pain prevention device during care.
Measured: Immediately after the 3rd intervention.
Thematic analysis of the verbatim collected during the semi-directive interviews with the parents after Care 3
Understand the social representations of parents and children regarding the use of a virtual reality device.
Measured: Immediately after the 3rd intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start30 Jun 2022
- Primary completion12 Dec 2024
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Nantes 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- For Ever Fabien
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042479
- Sponsor's protocol ID
- RC21_0008
- Acronym
- VIRTUOSO
- Status last verified
- Dec 2024
- First submitted
- 25 Aug 2021
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.
- ClinicalTrials.gov ID
- NCT05042479
- Acronym / sponsor ID
- VIRTUOSO / RC21_0008
- Keywords
- Pediatric, Pediatric oncology, Pain, Virtual reality, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- For Ever Fabien
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 13 Sep 2021 (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.
Medical procedures can be a very frightening experience for children. It is known that children who received painful medical procedures can develop a higher sensitivity of pain during their following experiences.
During their treatments for malignant diseases, children are exposed to a lot of painful procedures (eg. needle insertion, lumbar punction, myelogram, etc…)
Therefore, medical societies propose the use of interventions like distraction techniques for pain management in complement of pharmacological treatment.
In addition, the repetitions of painful procedures and ineffective prevention of pain can create care phobia.
Within this context, immersive and participative virtual reality (VR) could be an innovative distraction technique for pain management among children undergoing medical procedures.
Attention Pain Theory can explain how virtual reality can reduce the perception of pain. Attention is required to feel pain. When the patient is focused on another subject like an immersive virtual environment, his brain is less available to treat information like painful stimulus from care procedures.
The investigators hypothesis is that VR can reduce procedural-related pain and can decrease fear during the following procedures.
Results of previous studies are varied : some showed a non-significant reduction of patient's procedural pain despite the use of VR, whereas others concluded to a decrease of pain. The question of the benefit of VR for the patients who are exposed to repeated painful procedures remains still unclear, especially with patients who are likely to feel chronic pain or many pain-related exposures.
The aim of this study is to evaluate the non-inferiority of virtual reality as a distraction technique for pain management in children and adolescents with onco-hematological diseases, undergoing painful procedures, compared to standard of care.
Detailed description
VIRTUOSO is a study that aims to evaluate the impact of using a virtual reality headset to prevent care-induced pain in pediatric oncology. This study plans to include 34 patients. It is a single-center, non-inferiority, controlled, with cross-over study.
Efficiency of VR will be evaluated for each patient across 3 potentially painful care-procedures :
For the first treatment, the child will benefit usual distraction and pain prevention techniques.
For the 2nd treatment, the child will use a VR headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age.
For the 3rd treatment, the child will choose his/her favorite technique.
The virtual reality headset is an Occulus Quest headset, composed of 2 integrated earphones. It is adapted to the environment and can be used sitting or standing.
Usual pharmacological techniques for pain prevention will be maintained as per local practice.
All concomitant treatments are authorized except the use of oxygen-nitrous oxide mixtures.
The duration of this study is approximately 20 months. Inclusion will be for 10 months, patient follow-up for 6 months. Data analysis will be performed during 4 months.
During each treatment, if the child wishes to stop VR, the helmet will be removed and the usual techniques will be offered.
After each procedure, a self-assessment of the pain will be done immediately, using VAS.
At the end of the third treatment, a short questionnaire will be proposed to the child in order to collect the reasons for his choice. Another questionnaire will also be proposed to the parent present during the care.
A qualitative component will explore the social representations of the parents. A range of semi-directive interviews will be conducted with 6 families by a trained professional under the supervision of the methodologist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard treatment then virtual reality then choice between the two | Experimental | Other: Usual distraction and pain prevention techniques., Other: Virtual reality, Other: Choice between usual distraction or virtual realityEfficiency of VR will be evaluated for each patient across 3 potentially painful care-procedures : For the first treatment, the child will benefit usual distraction and pain prevention techniques. For the 2nd, the child will use a VR headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age and parental agreement. For the 3rd treatment, the child will choose his/her favorite technique. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Child aged 7 to 18 years
- Child followed in pediatric onco-hematology in the context of hematological malignancy or non malignant hematology or solid tumor management.
- Child who has already experienced a potentially painful care procedure before entry the study
- Child who will have the same potentially painful care procedure (Hüber needle placement or lumbar puncture) on three occasions during the course of their care.
- Child with consent.
Key exclusion criteria (4 listed)
- Child who refuse to use this distraction technique (VR).
- Child who refuse to not use MEOPA during VR.
- Child who hasn't experienced the potentially painful care procedure that will be done during the study at least once before inclusion
- Child who does not speak French and whose parents do not speak French
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 |
|---|---|---|
| Usual distraction and pain prevention techniques.For the first painful procedure, the child will benefit usual distraction and pain prevention techniques.Pain prevention and management techniques commonly used in the conduct of care: * Application of a patch or anaesthetic cream 1 hour before the treatment * Vigilant sedation using a premedication for lumbar punctures: Midazolam /Nalbuphine/Hydroxyzine/Morphine. * Apart from care using VR, MEOPA can be given to the child for all assessed care on prescription. * Apart from care using VR, the usual distraction techniques are left to the patient's choice (electronic tablet, smartphone, games, songs...) * The presence of the parents | Other | Standard treatment then virtual reality then choice between the two |
| Virtual realityFor the 2nd painful procedure, the child will use a VR (virtual reality) headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age. | Other | Standard treatment then virtual reality then choice between the two |
| Choice between usual distraction or virtual realityFor the 3rd painful procedure, the child will choose his/her favorite technique between : Usual distraction and pain prevention techniques or virtual reality | Other | Standard treatment then virtual reality then choice between the two |
Primary outcome
Pain level measured by VAS (self-evaluation) during the first care using standard treatment.
Time frame: Immediately after the first care.
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Pain level measured by VAS (self-evaluation) during the second care using virtual reality
Time frame: Immediately after the second care .
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Pain level measured by VAS (self-evaluation) during the third care using virtual reality or standard treatment
Time frame: Immediately after the third care .
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
6 secondary outcomes
Percentage of children who choose VR in the 3rd care
Time frame: Immediately after the 3rd intervention.
Patient questionnaire
Time frame: Immediately after the 3rd intervention.
Side effects to the use of VR
Time frame: During each intervention with virtual reality (care 2 and care 3 if VR is chosen). Up to 6 months.
Ethnographic approach to caregivers' experiences after using the VR headset.
Time frame: Through study completion - up to 20 months.
parent questionnaire.
Time frame: Immediately after the 3rd intervention.
Thematic analysis of the verbatim collected during the semi-directive interviews with the parents after Care 3
Time frame: Immediately after the 3rd intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual distraction and pain prevention techniques., Virtual reality and Choice between usual distraction or virtual reality in people with Hematologic Malignancy and Hematologic Non Malignancy, run by Nantes 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 10 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: finished, as of the sponsor's last update on 31 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level measured by VAS (self-evaluation) during the first care using standard treatment. (time frame: Immediately after the first care.). The study lists 3 primary outcomes in all. 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 31 Dec 2024.