Augmented and Virtual Reality for Needle Phobia

(SNAC Trial)

Overseen By Thomas Caruso, MD, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Neurological condition, Developmental disability, Motion sickness, Seizures, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: up to 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how augmented and virtual reality can help children and teens with a strong fear of needles. The researchers combine these technologies with cognitive behavioral therapy, a type of psychological treatment, to determine if they can reduce stress during blood draws and injections. Conducted at Stanford, the trial seeks participants aged 8-17 who have a significant fear of needles. This unphased trial offers a unique opportunity to explore innovative therapies that could make medical procedures less intimidating for young patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Spatial Computing Device and AR/VR exposure therapy is safe for children and adolescents with needle phobia?

Research has shown that Virtual Reality Exposure Therapy (VRET) is generally safe and manageable for participants. Studies have found that VRET effectively reduces needle-related anxiety and is well-received. Participants in these studies did not report any major negative effects.

In another study, Virtual Reality (VR) helped manage anxiety in medical settings without causing significant side effects. This suggests VR is safe for treating needle fear in children and teenagers.

Overall, current research considers combining Augmented Reality (AR) and VR with Cognitive Behavioral Therapy (CBT) to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using augmented and virtual reality exposure therapy combined with cognitive behavioral therapy (CBT) for needle phobia because this approach offers a unique and immersive way to confront and reduce fear. Unlike traditional treatments that rely solely on CBT or medications, augmented and virtual reality provide a safe, controlled environment where patients can gradually face their fears. This method allows for a more engaging and interactive experience, potentially leading to faster and more effective desensitization. By integrating technology with psychological therapy, this approach could revolutionize how needle phobia is managed, making treatment more accessible and appealing to patients who might be wary of traditional methods.

What evidence suggests that augmented and virtual reality exposure therapy could be effective for needle phobia?

Research has shown that augmented reality (AR) and virtual reality (VR) can reduce anxiety in people who fear needles. In this trial, participants will receive Cognitive Behavioral Therapy (CBT) combined with Extended Reality Exposure Therapy (XRET), which includes AR and VR. Studies have found that these technologies, when used with CBT, help people gradually face and manage their fears. Early results suggest that AR and VR provide a safe and controlled space for practicing coping skills during exposure therapy. This approach has effectively lowered anxiety levels and increased willingness to undergo procedures involving needles. While more research is needed, the initial findings are promising for treating needle phobia.

Who Is on the Research Team?

Aaron Lulla, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 8-17 with moderate to extreme needle phobia, as assessed by a specific measure. Participants must be undergoing surgery at LPCH or Stanford Hospital and have an active psychiatry consult for procedure-related anxiety. Exclusions include those with certain medical conditions, severe depression or PTSD, recent major surgery, vision impairments not correctable by contacts, and physical disabilities affecting hand use.

Inclusion Criteria

Patients who complete a patient survey via QR code at Stanford blood draw and/or primary care clinics

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)

I am between 8 and 17 years old.

Exclusion Criteria

I have had seizures triggered by flashing lights.

Legal guardian not present to obtain consent

History of severe motion sickness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Virtual Reality Exposure Therapy (VRET) using AR/VR devices combined with Cognitive Behavioral Therapy (CBT) to treat needle and blood-injection-injury phobia

up to 12 weeks

Multiple sessions as needed

Follow-up

Participants are monitored for safety, engagement, and effectiveness of the intervention

immediately after intervention

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Reality and Virtual Reality Exposure Therapy + Cognitive Behavioral Therapy
• Cognitive Behavioral Therapy Exposure Therapy

Trial Overview The study tests whether using Augmented Reality (AR) and Virtual Reality (VR) during Cognitive Behavioral Therapy (CBT) helps reduce needle phobia in young patients. It's conducted at Lucile Packard Children's Hospital and Stanford University to see if this tech-enhanced exposure therapy is effective.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy (CBT) + Extended reality exposure therapy (XRET) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07042074?term=AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=10

Study Details | NCT07042074 | Use of Augmented Reality ... Here we propose to conduct a feasibility study to determine the safety and acceptability of using VRET for children and adolescents with needle and blood- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12462493/

Virtual reality delivered exposure for fear of needles Virtual Reality Exposure-Based Therapy appears to be an effective and highly acceptable intervention for reducing immediate anxiety related to needle exposure, ...

3. patlynk.com patlynk.com/trial/NCT07042074

Spatial Computing Device with AR/VR for Needle Phobia ... This study explores how new technology, specifically virtual reality exposure therapy (VRET), can help children and adolescents who are scared of needles ...

4. games.jmir.org games.jmir.org/2023/1/e42025/

An Exposure-Based Video Game (Dr. Zoo) to Reduce Needle ... We designed and evaluated a serious exposure-based mobile game called Dr. Zoo to reduce the fear of needles in children aged 3 to 6 years.

5. link.springer.com link.springer.com/article/10.1007/s10055-025-01178-1

Virtual Reality - impact on anxiety reduction This study confirms VR's potential as an effective intervention for managing hematophobia in clinical contexts, particularly among patients with moderate ...