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

Not Applicable

Not yet recruiting

• Conditions: Needle Phobia; Virtual Reality; Cognitive Behavior Treatment

• Registration Number: NCT07042074
• Lead Sponsor: Stanford University

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 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

Study Timeline

• Study First Submitted: 2024-11-05
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-19
• Last Update Submitted: 2025-06-19
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-09-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Acceptability Survey	immediately after the intervention, up to12-week	Participants and their parents will be asked about their VRET exposure experience through the Treatment Experience Questionnaire. They will also complete the Treatment Evaluation Inventory (TEI), which includes both open-ended feedback questions, and 9 items rated on a 5-point Likert scale ((1= Strongly Disagree to 5= Strongly Agree). Higher scores indicate greater acceptability, accessibility, and usefulness of the intervention.
Drop out Feasibility	immediately after the intervention	The number of participants who discontinue the intervention will be recorded by the research team during each VRET session. It is used to evaluate engagement, tolerability, and feasibility of the intervention.
Adverse Events and Tolerability	baseline, immediately after the intervention	The Fast Motion Sickness screener (FMS) screener is a validated self-reported tool to assess the motion sickness induced during the VRET session. It ranges from 0 - 20, with 0 (no sickness at all) to 20 (frank sickness), assessing symptoms such as nausea, dizziness, etc. Higher scores indicate higher motion sickness.

Secondary Outcome Measures

Name	Time	Method
Time to Remission of Symptoms and Reduction in Anxiety Symptoms	baseline, immediately after the intervention, up to 12-weeks	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. The time to remission will be measured by the completion of sessions to reach remission, whether the participants complete the sessions as scheduled, or they need extra sessions.
Change in Anxiety During Exposure	baseline, immediately after the intervention	Anxiety levels will be measured by a Visual Analogue Scale - Anxiety (VAS-A), where participants rate their anxiety in a scale ranging from 0-10, with 0 representing no anxiety to 10 representing extreme anxiety. Higher scores indicate higher anxiety levels.
Heart Rate Monitoring	Periprocedural	Participant's heart rates will be measured using pulse oximeter during each VRET exposures. Higher HR may indicate heightened anxiety or stress.

Trial Locations

Locations (1)

Lucile Parkard Children's Hospital; 🇺🇸 Stanford, California, United States