All studies
RecruitingNAINTERVENTIONAL

Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting

This study is exploring a new way to help people manage pain and stress when they have a small medical device, called a Port-a-Cath, put under their skin. This device helps administer cancer treatments more easily. Traditionally, pain relief involves local anaesthetic and sometimes calming medicines or gas. This study is testing a new digital tool called Bliss DTx, which uses virtual reality (VR) with sounds and visuals to distract and relax patients. Researchers want to see if using Bliss DTx works as well as, or even better than, current methods for pain and anxiety relief. They also want to understand if it makes the process more satisfying for patients and if there are other benefits for hospitals.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Butterfly Therapeutics
Enrolment target
318
Start
12 Jun 2024
Estimated completion
12 May 2025

What is this study about?

When someone needs regular treatment for cancer, like chemotherapy, doctors often put a small device called a Port-a-Cath under the skin, usually in the chest area near the collarbone. This device makes it easier to give medicines and take blood samples without repeated needle sticks. Having this device put in can be uncomfortable and worrying, even with local anaesthetic to numb the area. Because of this, hospitals often offer extra help like calming medicines (sedatives) or special pain-relieving gas.

Researchers are now looking at a new digital tool called Bliss DTx. This tool uses virtual reality (VR) – where you wear a headset that shows you a different world with calming sounds and visuals – to help distract and relax you. The idea is that by focusing on the VR experience, you might feel less pain and anxiety during the Port-a-Cath procedure. A previous study for a different procedure suggested that Bliss DTx was as good as pain-relieving gas at managing pain.

This new study aims to see if Bliss DTx works just as well as, or better than, the usual ways of managing pain and anxiety (like calming medicines, relaxing gas, or talking therapy) when a Port-a-Cath is being put in. They also want to find out if patients feel more satisfied with the process when using Bliss DTx, and if it could make things run more smoothly for hospitals. It’s important to find ways to make medical procedures as comfortable and stress-free as possible for patients.

Key takeaways

  • A study comparing virtual reality (Bliss DTx) to standard pain relief during Port-a-Cath placement.
  • Aims to reduce pain and anxiety during the procedure.
  • Also looking at patient satisfaction and hospital benefits.
  • Involves using a VR headset during the procedure and answering questionnaires.
  • May offer a new way to make medical procedures more comfortable.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has been diagnosed with cancer and needs to have a Port-a-Cath fitted for the first time. You must also be having this procedure done as an outpatient, meaning you won't stay overnight in the hospital for it. You should also be able to understand and speak French, as the study materials and communication will be in French, and be part of a social security system.

There are some reasons why you wouldn't be able to join. For example, if you've already had a Port-a-Cath fitted before, this study isn't for you. You also can't take part if you have problems with how you feel pain, or if using virtual reality headsets or screens is not suitable for you (for example, if it makes you feel sick or dizzy). Pregnant women or patients who are considered legally 'protected' (meaning someone else makes decisions for them) also cannot participate.

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.

  1. Are you 18 years old or older?
  2. Do you have a cancer diagnosis?
  3. Do you need to have a Port-a-Cath placed for the first time?
  4. Will you be having your Port-a-Cath placed as an outpatient?
  5. Can you speak and understand French?
  6. Are you able to use virtual reality technology (no contraindications)?
Answer every question to see your result.

What does participation involve?

If you join this study, you will go through the Port-a-Cath procedure as planned. Instead of the usual calming medicines or gas, you would be using the Bliss DTx virtual reality headset during the procedure. You'll complete some brief questionnaires beforehand to measure your anxiety, and afterwards to assess your pain levels and how satisfied you were with the process. The total time for your involvement beyond your normal Port-a-Cath appointment would be minimal, mainly for completing these questionnaires.

Potential risks and benefits

Potential benefits of taking part could include experiencing less pain and anxiety during your Port-a-Cath procedure due to the distraction of the virtual reality. You might also feel more satisfied with your experience. As with any medical procedure, there are some minimal risks; for example, some people can feel dizzy or uncomfortable when using virtual reality. You will be closely monitored, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

  • CHU Angers
    Verified postcode
    Angers, France· Recruiting

Common questions

What is a Port-a-Cath and why do I need one?

A Port-a-Cath is a small device placed under your skin to make it easier to give medicines for cancer treatment, like chemotherapy, and to take blood tests, avoiding repeated needle pokes.

What is Bliss DTx?

Bliss DTx is a new digital tool that uses a virtual reality headset to create calming sounds and visuals. The idea is that this helps distract you and reduce pain and anxiety during medical procedures.

Will I still get pain relief if I use Bliss DTx?

Yes, you will still receive local anaesthesia to numb the area where the Port-a-Cath is placed. Bliss DTx is being tested as an additional way to help with pain and stress, instead of other calming medicines or gas.

Is using virtual reality safe?

Virtual reality is generally safe for most people. However, some people might feel dizzy or uncomfortable. The study will check if using VR is suitable for you beforehand.

What if I decide not to continue with the study?

You can leave the study at any time, for any reason. Your decision will not affect the medical care you receive.

How to find out more

Katell Le Dû, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Bliss DTx Assessment During Course Care Including Port-A-Cat…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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