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Spatial Computing Device with AR/VR for Needle Phobia Exposure Therapy

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Study AimThis study uses a spatial computing device with AR/VR to provide exposure therapy for people with needle phobia. We will assess the treatment's acceptability, feasibility, and any adverse events.
What is being tested

Mixed reality (XR) Exposure Therapy

Behavioral
Who is being recruted

From 8 to 17 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorStanford University
Study ContactAaron Lulla, MDMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2026Actual date on which the first participant was enrolled.

This study explores how new technology, specifically virtual reality exposure therapy (VRET), can help children and adolescents who are scared of needles and medical procedures involving blood. These fears can make it difficult for young people to get the care they need, sometimes requiring sedation to undergo necessary medical treatments. While there are some treatments available for adults with these phobias, there is limited information about how to help younger individuals. The study aims to see if using VRET with advanced spatial computing and augmented/virtual reality devices can reduce anxiety and make these treatments more engaging for children and teenagers. Participants in the study will use these advanced virtual reality devices to experience a controlled and safe simulation of situations involving needles and blood. This method allows them to face their fears in a gradual and manageable way, potentially reducing their anxiety over time. Researchers will evaluate the safety and effectiveness of this therapy by observing how well participants engage with the treatment and any changes in their anxiety levels. The study will take place at LPCH and Stanford Hospital, focusing on ensuring the therapy is both safe and acceptable for young patients.

Official TitleUse of a Spatial Computing Device and Augmented Reality and Virtual Reality for Exposure Therapy for Needle and Blood-Injection-Injury Phobia 
NCT07042074
Principal SponsorStanford University
Study ContactAaron Lulla, MDMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
20 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 8 to 17 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

Inclusion Criteria: 1. Patients between the ages of 8-17 2. Patients who complete a patient survey via QR code at Stanford blood draw and/or primary care clinics 3. Patients screened with the APA severity Measure for Specific Phobia (blood, needles, or injections), and have an individual phobia score rated as moderate, severe, or extreme (as described) Exclusion Criteria: 1. Legal guardian not present to obtain consent 2. Adolescent with a significant neurological condition, or major developmental disability 3. Adolescent with active infection of the face or hand 4. A history of severe motion sickness 5. A history of seizures caused by flashing light 6. An impending surgery within the last 48 hours 7. Adolescents who wear glasses and cannot use contacts 8. Adolescents with myopia or astigmatism 9. Adolescents with physical disabilities that prevent them from using their hands 10. Patients with substance use disorder in past year 11. Patients screened with PHQ-9 and found to have a depression score greater than 15 and/or those with a score greater than 1 or above for questions related to suicidality 12. Patients screened with Child PTSD Symptom Scale Self-Report (CPSS-SR5) and found to have score greater than 31 (indicating likely PTSD diagnosis)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

Participants will engage in a minimum 8-session intervention combining Cognitive Behavioral Therapy (CBT) and Extended Reality Therapy (XRET) to address needle phobia and blood-injection-injury (BII) phobia. The intervention begins with an initial intake session where the APA-SMS screener results are reviewed. Participants will then undergo VR exposure, with mixed exposure to sham needles in the latter exposure session. Anxiety levels will be assessed using a Visual Analog Scale (VAS-A) during and after each session. If fail to achieve the desired anxiety score, participants will continue working with the study team until ready to progress. The final session includes in-person exposure to a real needle, aiming for voluntary vaccination or IV placement. Coping strategies will be discussed at the final session. Participants will be contacted for follow-up assessments at 6 and 12 weeks to evaluate long-term outcomes.
Study Objectives
Primary Objectives

APA severity Measure for Specific Phobia (APA-SMS) is a validated tool used to assess the severity of specific phobia symptoms, including needle and blood-injection-injury (BII) phobia. The scale has 10 items, rated on a 5-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). The total score ranges from 0 - 40, with higher scores indicating greater severity of phobia. A change in symptom ratings from moderate/severe/extreme rating to mild/none indicates remission of symptoms by the end of intervention. The time to remission will be measured by the completion of sessions to reach remission, whether the participants complete the sessions as scheduled, or they need extra sessions.
Secondary Objectives

Change in sympathetic response to a scripted discussion regarding use of a needle and needle being shown - administered at the beginning of the first session and at the end of the last session.

Change in parasympathetic response to a scripted discussion regarding use of a needle and needle being shown. Measured via respiratory sinus arrhythmia (RSA) in hertz using chest biometric sensors in 30-second epochs.

Anxiety levels will be measured by a Visual Analogue Scale - Anxiety (VAS-A), where participants rate their anxiety in a scale ranging from 0-10, with 0 representing no anxiety to 10 representing extreme anxiety. Higher scores indicate higher anxiety levels.

Anxiety levels will be measured by a Visual Analogue Scale - Anxiety (VAS-A), where participants rate their anxiety in a scale ranging from 0-10, with 0 representing no anxiety to 10 representing extreme anxiety. Higher scores indicate higher anxiety levels.

User engagement will be measured by User Engagement Scale (UES) - Short. This scale consists of 12 items that participants will respond to, reflecting their feelings and interactions with the application or platform. Each item is rated on a Likert scale ranging from 1 to 5, where 1 indicates "strongly disagree" and 5 indicates "strongly agree."

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Lucile Parkard Children's HospitalStanford, United StatesSee the location
Recruiting soonOne Study Center
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