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Completed

NCT Number: NCT05883267

Virtual Reality and Children With Type 1 Diabetes

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.

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Key information

Conditions

Virtual Reality

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Noah Gruber

Ramat Gan, Please Select, 5265601, Israel

About this study

Children with T1D aged 8 to 15 years old, managed with CGM and insulin pumps, will be screened for participation. Key exclusion criteria include medical conditions that precluded use of the VR tool, such as epilepsy or vertigo, and diagnosed anxiety disorder.

Children will be randomly assigned (1:1 ratio) to one of the two groups. Upon every change of a CGM or pump infusion set, parents will be instructed to actively coach the child to use the designated intervention, VR glasses, or vocal-guided affective imagery, during the entire procedure. The VR glasses will be "PICO" model neo 2. The visual and vocal data content include both calming, affective imagery and interactive gaming, supplied by "XR-Health Israel Ltd". The vocal-guided affective imagery during the procedure will be identical to the vocal guide in the VR glasses. We plan 40 children in each group. The study will last for 2 months.

Questionnaires to assess anxiety and pain will be given to the children at baseline, during every CGM / pump infusion set change (every 3-14 days, depending on the device), and at one and two months after study initiation. Regimen adherence will be measured by changes in the number of insertion sites on the participants' bodies and by their willingness to change CGM / pump infusion sets themselves. Questionnaires administered at baseline, one month, and two months after the intervention will assess the use of aiding measures. Glycemic control measures that will be measured are comprised of differences between the interventions, in the percentage of time in range (TIR) 70-180 mg/dL, the percentage of time below range I (TBRI) <70 mg/dL and TBRII <54 mg/dL, the percentage of time above range I (TARI) >180 mg/dL andTARII >250 mg/dL, estimated HbA1c as measured by glucose management indicator (GMI), mean glucose, standard deviation, and the coefficient of variation (CV). A questionnaire that will assess the effectiveness and satisfaction of VR, and will evaluate the relief of diabetes distress following the intervention will be given at baseline, 1 and 2 months after the beginning.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Children with medical conditions not able to use virtual reality tool, such as epilepsy or vertigo.
  • Children with diagnosed anxiety disorder who are treated with medications.

Treatment and study plan

Virtual Reality Glasses

Device

"PICO" model neo 2 VR glasses

Vocal-guided affective imagery

Device

Audio via telephone

Primary outcomes

  1. Pain assessment

    Time frame: At baseline, during every CGM/ pump infusion set change (every 3-14 days, depending on the device), and at one and two months after study initiation.

    Questionnaires to assess pain will be given to the children at baseline, during every CGM/ pump infusion set change (every 3-14 days, depending on the device), and at one and two months after study initiation. Pain scale assessment (FACES scale) will be assessed. Range of scores for the pain scale is from 0-10. A higher number meaning worse pain.

  2. Anxiety assessment - state anxiety

    Time frame: At baseline, during every CGM/ pump infusion set change (every 3-14 days, depending on the device), and at one and two months after study initiation.

    Questionnaires to assess anxiety will be given to the children at baseline, during every CGM/ pump infusion set change (every 3-14 days, depending on the device), and at one and two months after study initiation. State anxiety will be assessed using the standardized Spielberger State-Trait Anxiety Inventory (STAI). State anxiety scores range from 6-24, with a higher number meaning higher anxiety.

  3. Anxiety assessment - trait anxiety

    Time frame: Baseline and 2 months after the intervention

    Questionnaires to assess anxiety will be given to the children at baseline and at two months after study initiation. Trait anxiety will be assessed using the standardized Spielberger State-Trait Anxiety Inventory (STAI). Trait anxiety scores range from 20-80, a higher number meaning higher anxiety.

Secondary outcomes

  1. Regimen adherence

    Time frame: Baseline, 1 month and 2 months after the intervention

    Regimen adherence will be measured by changes in the number of insertion sites on the participants' bodies and by their willingness to change CGM / pump infusion sets themselves. Questionnaires administered at baseline, one month, and two months after the intervention will assess the use of aiding measures.

  2. Glycemic control measures - percentage of time in range 70-180 mg/dL

    Time frame: Baseline, 1 month and 2 months after the intervention

    Glycemic control measures that will be measured are comprised of differences between the interventions in the percentage of time in range 70-180 mg/dL.

  3. Glycemic control measures - percentage of time below range <70 mg/dL

    Time frame: Baseline, 1 month and 2 months after the intervention

    Glycemic control measures that will be measured are comprised of differences between the interventions in the percentage of time below range <70 mg/dL.

  4. Glycemic control measures - percentage of time below range <54 mg/dL

    Time frame: Baseline, 1 month and 2 months after the intervention

    Glycemic control measures that will be measured are comprised of differences between the interventions in the percentage of time below range <54 mg/dL.

  5. Glycemic control measures - percentage of time above range I >180 mg/dL

    Time frame: Baseline, 1 month and 2 months after the intervention

    Glycemic control measures that will be measured are comprised of differences between the interventions in the percentage of time above range >180 mg/dL

  6. Glycemic control measures - percentage of time above range >250 mg/dL

    Time frame: Baseline, 1 month and 2 months after the intervention

    Glycemic control measures that will be measured are comprised of differences between the interventions in the percentage of time above range >250 mg/dL.

  7. Glycemic control measures - estimated HbA1c as measured by glucose management indicator (GMI)

    Time frame: Baseline, 1 month and 2 months after the intervention

    Glycemic control measures that will be measured are comprised of differences between the interventions in estimated HbA1c as measured by glucose management indicator (GMI).

  8. Glycemic control measures - mean glucose

    Time frame: Baseline, 1 month and 2 months after the intervention

    Glycemic control measures that will be measured are comprised of differences between the interventions in mean glucose.

  9. Glycemic control measures - standard deviation

    Time frame: Baseline, 1 month and 2 months after the intervention

    Glycemic control measures that will be measured are comprised of differences between the interventions in standard deviation.

  10. Glycemic control measures - coefficient of variation (CV)

    Time frame: Baseline, 1 month and 2 months after the intervention

    Glycemic control measures that will be measured are comprised of differences between the interventions in coefficient of variation (CV).

  11. VR Satisfaction and effectiveness assessment

    Time frame: Baseline, 1 month and 2 months after the intervention

    A questionnaire that will assess the effectiveness and satisfaction of VR, and will evaluate the relief of diabetes distress following the intervention will be given at baseline, 1 and 2 months after the beginning.

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 31, 2023
Registry last updated
Jun 25, 2024

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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