Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.

Hematologic Malignancy Clinical Trial

— VIRTUOSO  

Official title:

Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042479
• Other study ID #: RC21_0008
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: February 11, 2025

Study information

• Verified date: December 2023
• Source: Nantes University Hospital
• Contact: Thomas JEZEQUEL
• Phone: (0)2.76.64.38.63
• Email: thomas.jezequel[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: February 11, 2025
• Est. primary completion date: February 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

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.
• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Child, Only
• Hematologic Malignancy
• Hematologic Neoplasms
• Pain, Procedural
• Solid Tumor, Childhood

Intervention

Other:
• 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
• Virtual reality
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 reality
For the 3rd painful procedure, the child will choose his/her favorite technique between : Usual distraction and pain prevention techniques or virtual reality

Locations

Country	Name	City	State
France	Nantes CHU	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	For Ever Fabien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after the first care.
Primary	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.	Immediately after the second care .
Primary	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.	Immediately after the third care .
Secondary	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.	Immediately after the 3rd intervention.
Secondary	Patient questionnaire	Analysis of the answers to the patient questionnaire after treatment n°3. Description of the reasons for selecting the preferred technique.	Immediately after the 3rd intervention.
Secondary	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.	During each intervention with virtual reality (care 2 and care 3 if VR is chosen). Up to 6 months.
Secondary	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.	Through study completion - up to 20 months.
Secondary	parent questionnaire.	Analysis of the responses to the parent questionnaire. Understand parents' experience of care when implementing a new pain prevention device during care.	Immediately after the 3rd intervention.
Secondary	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.	Immediately after the 3rd intervention.