Virtual RealityNCT05883267
Virtual Reality and Children With Type 1 Diabetes
A study testing Virtual reality glasses and Vocal-guided affective imagery in people with Virtual Reality, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual reality glasses and Vocal-guided affective imagery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 10 May 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and young adults aged 8-15 years with type 1 diabetes with continuous glucose monitoring (CGM) and insulin pump.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality's Impact on Children With Type 1 Diabetes: a Randomized Cross-over Trial on Anxiety, Pain, Adherence, and Glycemic Control
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.
Read the detailed description
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.
- Conditions
- Virtual Reality
- Being tested
- Virtual reality glasses, Vocal-guided affective imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glassesDevice
"PICO" model neo 2 VR glasses
Vocal-guided affective imageryDevice
Audio via telephone
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | 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. Receives: Device: Virtual reality glasses |
| Audio | Active comparator | The vocal-guided affective imagery during the procedure will be identical to the vocal guide in the VR glasses. Receives: Device: Vocal-guided affective imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
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.
Measured: 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.
Anxiety assessment - state anxiety
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.
Measured: 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.
Anxiety assessment - trait anxiety
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.
Measured: Baseline and 2 months after the intervention
Secondary outcomes (11)
Regimen adherence
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.
Measured: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - percentage of time in range 70-180 mg/dL
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.
Measured: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - percentage of time below range <70 mg/dL
Glycemic control measures that will be measured are comprised of differences between the interventions in the percentage of time below range <70 mg/dL.
Measured: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - percentage of time below range <54 mg/dL
Glycemic control measures that will be measured are comprised of differences between the interventions in the percentage of time below range <54 mg/dL.
Measured: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - percentage of time above range I >180 mg/dL
Glycemic control measures that will be measured are comprised of differences between the interventions in the percentage of time above range >180 mg/dL
Measured: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - percentage of time above range >250 mg/dL
Glycemic control measures that will be measured are comprised of differences between the interventions in the percentage of time above range >250 mg/dL.
Measured: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - estimated HbA1c as measured by glucose management indicator (GMI)
Glycemic control measures that will be measured are comprised of differences between the interventions in estimated HbA1c as measured by glucose management indicator (GMI).
Measured: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - mean glucose
Glycemic control measures that will be measured are comprised of differences between the interventions in mean glucose.
Measured: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - standard deviation
Glycemic control measures that will be measured are comprised of differences between the interventions in standard deviation.
Measured: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - coefficient of variation (CV)
Glycemic control measures that will be measured are comprised of differences between the interventions in coefficient of variation (CV).
Measured: Baseline, 1 month and 2 months after the intervention
VR Satisfaction and effectiveness assessment
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.
Measured: Baseline, 1 month and 2 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start10 May 2023
- Primary completion1 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Noah Gruber, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883267
- Sponsor's protocol ID
- SHEBA-21-816421-NG-CTIL
- Status last verified
- Apr 2023
- First submitted
- 23 Apr 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not intended
Publications
Gruber N, Shemesh-Iron M, Kraft E, Mitelberg K, Mauda E, Ben-Ami M, Mazor-Aronovitch K, Levy-Shraga Y, Levran N, Levek N, Zimlichman E, Pinhas-Hamiel O. Virtual reality's impact on children with type 1 diabetes: a proof-of-concept randomized cross-over trial on anxiety, pain, adherence, and glycemic control. Acta Diabetol. 2024 Feb;61(2):215-224. doi: 10.1007/s00592-023-02195-9. Epub 2023 Oct 16.
PubMed 37845502
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality's Impact on Children With Type 1 Diabetes: a Randomized Cross-over Trial on Anxiety, Pain, Adherence, and Glycemic Control
- ClinicalTrials.gov ID
- NCT05883267
- Acronym / sponsor ID
- SHEBA-21-816421-NG-CTIL
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual reality glassesThe 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. |
| Audio | Active comparator | Device: Vocal-guided affective imageryThe vocal-guided affective imagery during the procedure will be identical to the vocal guide in the VR glasses. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children and young adults aged 8-15 years with type 1 diabetes with continuous glucose monitoring (CGM) and insulin pump.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality glasses"PICO" model neo 2 VR glasses | Device | Virtual reality |
| Vocal-guided affective imageryAudio via telephone | Device | Audio |
Primary outcome
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.
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.
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.
11 secondary outcomes
Regimen adherence
Time frame: Baseline, 1 month and 2 months after the intervention
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 - percentage of time below range <70 mg/dL
Time frame: Baseline, 1 month and 2 months after the intervention
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 - percentage of time above range I >180 mg/dL
Time frame: Baseline, 1 month and 2 months after the intervention
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 - estimated HbA1c as measured by glucose management indicator (GMI)
Time frame: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - mean glucose
Time frame: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - standard deviation
Time frame: Baseline, 1 month and 2 months after the intervention
Glycemic control measures - coefficient of variation (CV)
Time frame: Baseline, 1 month and 2 months after the intervention
VR Satisfaction and effectiveness assessment
Time frame: Baseline, 1 month and 2 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 37845502Gruber N, Shemesh-Iron M, Kraft E, Mitelberg K, Mauda E, Ben-Ami M, Mazor-Aronovitch K, Levy-Shraga Y, Levran N, Levek N, Zimlichman E, Pinhas-Hamiel O. Virtual reality's impact on children with type 1 diabetes: a proof-of-concept randomized cross-over trial on anxiety, pain, adherence, and glycemic control. Acta Diabetol. 2024 Feb;61(2):215-224. doi: 10.1007/s00592-023-02195-9. Epub 2023 Oct 16.
- Individual participant dataSharing planned: No. Not intended
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Gruber, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality glasses and Vocal-guided affective imagery in people with Virtual Reality, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.