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

Stanford University

Status: Begins enrollment in 1 month

Conditions: Needle Phobia; Cognitive Behavior Treatment; Virtual Reality

Treatments: Behavioral: Augmented Reality (AR) / Virtual reality (VR) Exposure Therapy + Cognitive Behavioral Therapy (CBT) Exposure Therapy; Behavioral: Cognitive Behavioral Therapy (CBT) Exposure Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07042074

77696

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 child 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 AR/VR 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 case series 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, and to determine if the use of a spatial computing and AR/VR device can clinically 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

• Patients between the ages of 8-17
• Patients who will be undergoing a surgical procedure at LPCH and Stanford Hospital and who require a preoperative anesthesia consult
• Patients with an active consultation to child and adolescent psychiatry for anxiety related to procedures
• Patients who complete a patient survey via QR code at Stanford blood draw and/or primary care clinics
• 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

• 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
• Major surgery within the last 48 hours
• Adolescents who wear glasses and cannot use contacts
• Adolescents with myopia or astigmatism
• Adolescents with physical disabilities that prevent them from using their hands
• Patients with substance use disorder in past year
• 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
• 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: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Augmented Reality (AR)

Experimental group

Description:

AR will be used together with the Virtual reality (VR) and the Cognitive Behavioral Therapy (CBT) Exposure Therapy

Treatment:

Behavioral: Augmented Reality (AR) / Virtual reality (VR) Exposure Therapy + Cognitive Behavioral Therapy (CBT) Exposure Therapy

Virtual reality (VR)

Experimental group

Description:

VR will be used together with the Augmented Reality (AR) and the Cognitive Behavioral Therapy (CBT) Exposure Therapy

Treatment:

Behavioral: Augmented Reality (AR) / Virtual reality (VR) Exposure Therapy + Cognitive Behavioral Therapy (CBT) Exposure Therapy

Cognitive Behavioral Therapy (CBT) Exposure Therapy

Experimental group

Description:

AR and VR will be used together with the Cognitive Behavioral Therapy (CBT) Exposure Therapy

Treatment:

Behavioral: Augmented Reality (AR) / Virtual reality (VR) Exposure Therapy + Cognitive Behavioral Therapy (CBT) Exposure Therapy

Traditional Cognitive Behavioral Therapy (CBT) Exposure Therapy

Active Comparator group

Description:

Traditional Cognitive Behavioral Therapy (CBT) Exposure Therapy without the use of AR/VR

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT) Exposure Therapy