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

NCT ID: NCT07042074

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-31

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).

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 (VRET) 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 VRET.

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-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 VRET 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Mixed reality (XR) Exposure Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

Mixed reality (XR) Exposure Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Caruso

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron Lulla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Parkard Children's Hospital

Stanford, California, United States

Countries

United States

Central Contacts

Aaron Lulla, MD

Role: CONTACT

alulla@stanford.edu

310-478-3711

Thomas Caruso, MD, PhD

Role: CONTACT

tjcaruso@stanford.edu

6504970927

Other Identifiers

77696

Identifier Type: -

Identifier Source: org_study_id