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

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.

Conditions

• Hematologic Malignancy
• Hematologic Non Malignancy
• Solid Tumor, Childhood
• Child, Only

Interventions

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

OTHER

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.

OTHER

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

Sponsors & Collaborators

• For Ever Fabien

  collaborator UNKNOWN

• Nantes University Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-30

Primary Completion

2024-12-12

Completion

2024-12-24

Countries

• France

Study Locations