Using virtual reality to reduce pain and anxiety during needle placements in children with leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of using interactive or hypnotic virtual reality to manage pain and anxiety during needle placements for children and adolescents aged 6 to 16 with acute leukemia. Over a period of three months, participants will receive either virtual reality interventions or standard treatment while undergoing needle insertion into an implantable port. The study aims to assess improvements in pain management, anxiety levels, and overall satisfaction for both the children and their caregivers compared to traditional methods. The goal is to provide a non-drug intervention that enhances the care experience for these young patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children from 6 to 16 years old suffering from leukemia requiring needle insertion into an implantable port and having a life expectancy greater than or equal to 3 months
* Subjects and their parents who have been informed of the study and having expressed their informed consent
* Children without contraindications to the use of MEOPA® :
* Patient requiring 100% oxygen ventilation
* Intracranial hypertension
* Any alteration in the state of consciousness preventing the patient\'s cooperation
* Children without contraindication to the use of the virtual reality mask:
* Epilepsy
* Psychiatric illness
* Children and parents able to use the self-assessment scales proposed in the study
* Enrolment in the Social Security system

Exclusion Criteria:

Children from 6 to 16:

* Having a modification of pain\'s integration (spina bifida for example)
* Requiring contact isolation (conjunctivitis, contagious skin condition, etc.)
* With a history of seizures

Where it's running

• CHU de Bordeaux
  Bordeaux, France Recruiting
• CHU de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Assistance Publique - Hôpitaux de Marseille
  Marseille, France Recruiting
• CHU de Toulouse
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Alexandra USCLADE — University Hospital, Clermont-Ferrand
• Study coordinator: Lise LACLAUTRE
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: +33473754963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.