RecruitingNAINTERVENTIONAL

Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia

This research is exploring new ways to make needle procedures easier for children and teenagers (aged 6 to 16) who have leukaemia. These children often need regular needles into a special port under their skin, which can be painful and worrying for them and their parents. The study compares two types of virtual reality (VR) – interactive games or calming, hypnotic VR experiences – with the usual methods used to help children cope. We want to see if using VR repeatedly over three months can better manage pain, reduce anxiety for children and their parents, and improve everyone's satisfaction with care compared to existing approaches. The goal is to make these necessary treatments less stressful.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

120

Start

15 Nov 2024

Estimated completion

01 Oct 2027

Virtual Reality Children and Adolescents Acute Leukemia Anxiety and Fear

What is this study about?

When children and teenagers are diagnosed with leukaemia, they often need many medical procedures that can be quite uncomfortable or even painful, and often cause a lot of worry. One common procedure involves putting a needle into a special device, often called an implantable port or port-a-cath, which sits just under the skin. This port allows doctors and nurses to give chemotherapy, other medicines, and take blood samples without having to find a new vein each time. While this makes treatment easier in the long run, the needle insertion itself can still be a source of pain and anxiety, especially since it needs to happen regularly, sometimes for many months.

Currently, healthcare providers use things like numbing patches on the skin to reduce pain. They also try to distract children with conversation. While these methods help, they often aren't enough to fully ease the child's worry or completely stop the memory of past pain from making future procedures even more stressful. This study wants to find out if virtual reality (VR) could offer a better solution. VR involves putting on a headset that creates a 3D world with sights and sounds, helping to take a child’s mind off the procedure.

We are looking into two types of VR: one where children can play interactive games and another where they experience calming or 'hypnotic' virtual environments. Both types aim to fully immerse the child, diverting their attention away from the needle and the hospital setting. By comparing these VR methods with the standard care, we hope to learn if repeated use of VR can significantly reduce the pain and anxiety children feel during these needle procedures, not just for the child but also for their parents and the healthcare staff involved.

Key takeaways

New study exploring virtual reality for children aged 6-16 with leukaemia.
Aims to reduce pain and anxiety during needle procedures for implantable ports.
Compares interactive VR games or calming VR experiences to standard care.
Participation lasts for three months, during regular treatment visits.
Hopes to improve comfort and satisfaction for children, parents, and staff.
No changes to your child's leukaemia treatment itself.

Who may be eligible?

This study is looking for children and teenagers between 6 and 16 years old who have acute leukaemia and need regular needle insertions into their implantable port. To be part of the study, they need to be expected to live for at least three more months, as the study runs for three months.

It's important that both the child and their parents understand the study and agree to take part. There are certain health conditions that would prevent someone from joining, such as having epilepsy, serious psychiatric illness, or specific pain conditions that affect how they feel pain. Also, if a child needs 100% oxygen or has certain brain conditions, they might not be able to participate. They also need to be able to use the simple scales we provide to rate their pain and anxiety.

Children who are in isolation due to contagious conditions, or have had seizures in the past, cannot be included. The aim is to ensure the study is safe and beneficial for everyone involved. All participants must also be registered with the UK Social Security system.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 6 and 16 years old?
Does your child have acute leukaemia and need a port needle for treatment?
Do you and your child understand the study and agree to take part?
Does your child NOT have epilepsy, serious mental health conditions, or certain brain issues?
Is your child able to use simple rating scales for pain and anxiety?
Is your child not currently in contact isolation (e.g., for an infection)?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive either virtual reality (VR) or standard care each time they need a needle placed in their implantable port for a period of three months. This will happen during their regular hospital visits for their leukaemia treatment, either in the oncology department or day hospital. During each of these procedures, we will ask your child to rate their pain and anxiety using simple scales. Parents will also be asked about their child's anxiety and their own satisfaction with the care. Healthcare staff will also share their feedback on the process. There won't be any extra hospital visits just for the study; it will fit into your child's existing treatment schedule. The total duration of active participation for each child will be three months.

Potential risks and benefits

Taking part in this study may offer some benefits, as the virtual reality could help reduce your child's pain and anxiety during needle procedures, potentially making their treatment experience more positive. Even if your child doesn't use VR, they will still receive standard care aimed at managing pain and anxiety. As with any new approach, there's always a small chance that VR might not be suitable for every child, or it might not work as well for some. There are very few known risks with VR beyond motion sickness for a very small number of people. We will carefully check if VR is safe for your child before they start. You are completely free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (4)

CHU de Bordeaux
Verified postcode
Bordeaux, France· Recruiting
CHU de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
Assistance Publique - Hôpitaux de Marseille
Verified postcode
Marseille, France· Recruiting
CHU de Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is an implantable port?

It's a small device placed under the skin, usually in the chest, that connects to a large vein. It means doctors can give medicines or take blood samples without needing to find a vein with a needle every time.

What is virtual reality (VR)?

VR uses a special headset that show 3D videos and sounds, making you feel like you are in a different place, like exploring a game world or a calm environment.

Will using VR stop all pain?

Our aim is to significantly reduce pain and anxiety, but it might not stop all feelings of discomfort. We hope it makes the experience much easier to manage.

Will my child's regular treatment change if they join?

No, your child's regular leukaemia treatment will continue exactly as planned. This study only looks at how we manage the needle procedures, not the treatment itself.

What if my child doesn't like the VR?

If your child finds the VR uncomfortable or doesn't want to use it, they can stop at any time. Their medical care will not be affected.

How to find out more

Lise LACLAUTRE

promo_interne_drci@chu-clermontferrand.fr +33473754963 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.