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

NCT07042074 | Not Yet Recruiting

• 1 other identifier: 77696
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Needle Phobia; Virtual Reality; Cognitive Behavior Treatment

Outcome Measures

Primary Outcomes (1)

• Change in anxiety symptoms related to needle phobia and BII

  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.

  Baseline, immediately after the intervention of week 4 and week 5, 6 and 12 weeks after completion of treatment

Secondary Outcomes (5)

• Skin Conductance Response Density (SCRD)

  during the first intervention, week 4, week 5 and last intervention.

• Parasympathetic response indexed by Respiratory sinus arrhythmia (RSA)

  during the first intervention, week 4, week 5 and last intervention.

• Change in Anxiety after virtual exposure

  Baseline, immediately after the intervention

• Change in Anxiety after real exposure

  during intervention, immediately after the intervention

• User engagement

  Immediately after final intervention

Study Arms (1)

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

EXPERIMENTAL

Behavioral: Mixed reality (XR) Exposure Therapy

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.

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

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients between the ages of 11-17
• Fear of needle
• Patients screened with the modified APA severity Measure for Specific Phobia (blood, needles, or injections), and have an individual phobia score rated as moderate, severe, or extreme (as described below)

You may not qualify if:

• Legal guardian not present to obtain consent
• Adolescent with a significant neurological condition, or major developmental disability
• Adolescent with active infection of the face or hand
• A history of severe motion sickness
• A history of seizures caused by flashing light
• An impending surgery within the last 48 hours
• Adolescents who wear glasses and cannot use contacts
• Adolescents with physical disabilities that prevent them from using their hands
• Patients with substance use disorder in past year
• Virtual Reality headsets do not fit.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Parkard Children's Hospital

Stanford, California, 94304, United States

Location

MeSH Terms

Interventions

Implosive Therapy

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Aaron Lulla, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Lulla, MD

CONTACT

310-478-3711; alulla@stanford.edu

Thomas Caruso, MD, PhD

CONTACT

6504970927; tjcaruso@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: June 27, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

US (1)