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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT07042074
Status
Enrolling By Invitation

Conditions

  • Cognitive Behavior Treatment
  • Needle Phobia
  • Virtual Reality

Eligibility Criteria

Sex
ALL
Age
11 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Mixed reality (XR) Exposure Therapy — BEHAVIORAL
    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.

Study Details

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).

Key Dates

First listed
Jun 27, 2025
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive Behavioral Therapy (CBT) + Extended reality exposure therapy (XRET)

Primary Outcome Measure

Change in anxiety symptoms related to needle phobia and BII [ Time Frame: Baseline, immediately after the intervention of week 4 and week 5, 6 and 12 weeks after completion of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Parkard Children's HospitalStanfordCalifornia94304-

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Lucile Parkard Children's Hospital· Stanford, CA

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