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NCT Number: NCT06697275

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

Main objective:

Evaluate the effectiveness of the repeated use of interactive or hypnotic virtual reality compared to standard treatment, on pain, during each needle placement on PAC for 3 months on children or adolescents (6 to 16 years old) with acute leukemia

Hypothesis:

Repeated use over 3 months of hypnotic or interactive virtual reality provides more benefits in terms of :

* pain management * anxiety of the child and his parents * satisfaction of the child's care, of his parents and of the caregivers compared to the standard method when inserting a needle into an implantable port in the pediatric oncology department or day hospital.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux, Bordeaux, France

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About this study

Children and adolescents with acute leukemia frequently have anxiety-provoking and painful care in the management of their disease. As soon as the diagnosis is announced, the installation of a central line is recommended to allow the administration of chemotherapy treatments, parenteral nutrition, and blood tests. The implantable port (IP) is more often used than the central catheter. It allows the injection of drugs directly into the implantable port, through the skin using a specific needle whose caliber can be variable. This treatment, which can be repeated weekly, causes pain and anxiety for children. The use of skin anesthetic patches (EMLA®) is recommended to limit pain during needle installation. According to the literature, this system limits the pain associated with needle injections but does not reduce children's anxiety about this upcoming treatment. The repetition of the gesture, often for several months, is a source of discomfort and pain that only increases over time. A memorization of pain increases the apprehension of care by the child, his parents and can also create difficult care conditions for the caregiver. These children receive multiple treatments, which is why a non-drug intervention is recommended for the management of pain and anxiety. Standard distraction (e.g.: speech) is recommended but it is often insufficient. This is why the use of interactive or hypnotic virtual reality (VR) could improve the care of these children and in particular reduce anxiety and fear. The immersion of the child in a three-dimensional environment with sound and visual stimulation potentiates the diversion of his attention. Thus, it seems necessary to evaluate the impact of interactive or hypnotic virtual reality on pain and anxiety during repeated painful care in children with acute leukemia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypnotic Virtual reality

Device

Hypnotic Virtual reality mask Deepsen® with age-appropriate software Birdy®

Interactive virtual reality

Device

Interactive virtual reality mask Deepsen® with age-appropriate software Birdy®

Standard method

Other

Use of local anesthesic cream + Nurse and/or parents distraction +/- anxioloytic gas

Primary outcomes

  1. Children's pain self-evaluation

    Time frame: 15 minutes after the care

    Self-evaluation of children's pain with the visual analog scale in vertical position.

    Quote from 0 to 10 with 10 being the worst score.

Secondary outcomes

  1. Children's fear evaluation

    Time frame: 15 minutes before the care and right after the procedure

    Children's fear evaluation by the nurse with the visual analog scale from 0 to 10 with 10 being the worst score

  2. Children's heart rate measurement

    Time frame: 15 minutes before the care and right after the procedure

    Heart rate mesure using a digital sensor

  3. Evaluation of the care

    Time frame: After each care from the date of randomization and assessed during 3 months

    Satisfaction of the care given to the child filled out by nurses, parents and child using a questionnaire. Score going fro 1 to 3 with 3 being the best score = very satisfied

Study contacts

Contact information is provided by the study sponsor or research team.

Lise LACLAUTRE

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: LEAVE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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