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NCT05883267Completed

Virtual Reality and Children With Type 1 Diabetes

Virtual Reality's Impact on Children With Type 1 Diabetes: a Randomized Cross-over Trial on Anxiety, Pain, Adherence, and Glycemic Control

Source: ClinicalTrials.gov · Last updated 25 Jun 2024

Brief summary (registry, in English)

For children with type 1 diabetes (T1D), pain and needle phobia can cause postponing of changes in insulin pump infusion sets and continuous glucose monitors, and thus worsen glycemic control. We aim to assess the effectiveness of virtual reality (VR) technology, in reducing pain and anxiety, and improving regimen adherence and glycemic control among children with type 1 diabetes (T1D). Children with T1D, managed with continuous glucose monitoring and insulin pumps, will be recruited for a randomized cross-over trial. Children will be randomized to one of two interventions for diabetes management: group 1 will use VR glasses first and group 2 will listen to vocal-guided affective imagery first (audio). After 1 month, the interventions will be crossed over. The outcome measures will include pain and anxiety assessment, regimen adherence, glycemic control, and patient-reported outcome measures (PROMs) of VR satisfaction and effectiveness.

Status (registry)
Completed
Study type
Interventional
Enrollment
40 (actual)
First submitted
23 Apr 2023
Start date
10 May 2023
Primary completion date
1 Dec 2023
Lead sponsor
Sheba Medical Center
NCT number
NCT05883267

What you commit to

  • Study type: Interventional
  • Participants enrolled: 40
  • From 10 May 2023 to the primary completion date, 1 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Children with diagnosed anxiety disorder who are treated with medications.

Other illness

  • Children with medical conditions not able to use virtual reality tool, such as epilepsy or vertigo.

Who the study is looking for

  • Children and young adults aged 8-15 years with type 1 diabetes with continuous glucose monitoring (CGM) and insulin pump.

Age in the registry: 8 years to 15 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Noah Gruber
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.