NCT07042074

Use of Augmented Reality and Virtual Reality During Cognitive Behavioral Therapy for Needle Phobia

Use of a Spatial Computing Device and Augmented Reality and Virtual Reality for Exposure Therapy for Needle and Blood-Injection-Injury Phobia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This case series study seeks to evaluate the use of a Spatial Computing Device and Augmented Reality (AR) and Virtual Reality (VR) as an exposure therapy modality for children and adolescents with needle and blood-injection-injury phobia. This study will take place at Lucile Packard Children's Hospital (LPCH) and Stanford Hospital (Stanford University, Palo Alto, CA).

Detailed description

Needle phobia and Blood-Injection-Injury phobia are anxieties that are observed in children, adolescents, and adults undergoing medical/surgical procedures and the use of needles. These phobias can lead to an impediment of care for children or adolescents and may impact their ability to participate in care and/or receive essential treatments. This can lead to significant delays in treatment of individuals and medical trauma for patients who can only receive treatments/procedures using needles after undergoing sedation. Although treatment protocols exist for treating needle and blood-injection-injury phobia in adults, the literature regarding treatment in children and adolescents is limited. Additionally, the use of medications for management of needle phobia can lead to increased medical complications and may not resolve the underlying cause of needle phobia. Recent technological developments have led to the use of virtual reality exposure therapy (XRET) for treating needle and blood-injection-injury phobia, however few studies have been performed in children, and the literature regarding anxiety and clinical outcomes using this treatment modality is lacking in this population. Further, newly developed spatial computing and XR (Mixed Reality) devices have led to advancements in immersion and personalization of images/videos, and as such may lead to increased engagement and clinical efficacy for patients participating in XRET. Here we propose to conduct a study to determine the effectiveness of using XRET for children and adolescents with needle and blood-injection-injury phobia undergoing procedures at LPCH and Stanford Hospital. This feasibility study will serve as the basis for a larger scale RCT to determine if XRET can serve as an alternative to traditional exposure therapy methods to improve anxiety related to these phobias, and increase engagement/participation with treatment.

Conditions

• Needle Phobia
• Virtual Reality
• Cognitive Behavior Treatment

Interventions

Type	Name	Description
BEHAVIORAL	Mixed reality (XR) Exposure Therapy	Participants will engage in a maximum 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 VAS-A score is less or equal to 5, participants will be able to proceed. If VAS-A score is greater than 5, participants will have the option to exit the study or proceed. 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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2025-06-27
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States