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

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Stanford University

Status

Not yet enrolling

Conditions

Needle Phobia
Cognitive Behavior Treatment
Virtual Reality

Treatments

Behavioral: Mixed reality (XR) Exposure Therapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Cognitive Behavioral Therapy (CBT) + Extended reality exposure therapy (XRET)
Experimental group
Treatment:
Behavioral: Mixed reality (XR) Exposure Therapy

Trial contacts and locations

1

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Central trial contact

Thomas Caruso, MD, PhD; Aaron Lulla, MD

Data sourced from clinicaltrials.gov

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