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Virtual Reality and Children With Type 1 Diabetes

NCT05883267 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-06-25

No results posted yet for this study

Summary

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.

Conditions

  • Virtual Reality

Interventions

DEVICE

Virtual reality glasses

"PICO" model neo 2 VR glasses

DEVICE

Vocal-guided affective imagery

Audio via telephone

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Noah Gruber, MD · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2023-12-01
Completion
2023-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05883267 on ClinicalTrials.gov