Use of Augmented Reality and Virtual Reality During Cognitive Behavioral Therapy for Needle Phobia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mixed reality (XR) Exposure Therapy.
- Who it may be relevant to
- Registry conditions: Needle Phobia, Virtual Reality, Cognitive Behavior Treatment. Basic parameters: 11 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of a Spatial Computing Device and Augmented Reality and Virtual Reality for Exposure Therapy for Needle and Blood-Injection-Injury Phobia
Overview
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 (XRET) 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 XRET.
The study aims to evaluate the effectiveness of combining cognitive behavioral therapy (CBT) and extended reality exposure therapy (XRET) for treating needle and blood-injection-injury (BII) phobia in children and adolescents. The intervention requires direct observation of human participants' psychological and physiological responses to exposures. These measurements, including anxiety levels and sympathetic/parasympathetic activity, can only be obtained from human subjects to assess treatment efficacy.
Interventions
- Behavioral Mixed reality (XR) Exposure Therapy
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 a
Primary outcome measures
- Change in anxiety symptoms related to needle phobia and BII [Time frame: Baseline, immediately after the intervention of week 4 and week 5, 6 and 12 weeks after completion of treatment]
Secondary outcome measures (5)
- Skin Conductance Response Density (SCRD) [Time frame: during the first intervention, week 4, week 5 and last intervention.]
- Parasympathetic response indexed by Respiratory sinus arrhythmia (RSA) [Time frame: during the first intervention, week 4, week 5 and last intervention.]
- Change in Anxiety after virtual exposure [Time frame: Baseline, immediately after the intervention]
- Change in Anxiety after real exposure [Time frame: during intervention, immediately after the intervention]
- User engagement [Time frame: Immediately after final intervention]
Eligibility criteria
Inclusion criteria
- 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)
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Lucile Parkard Children's Hospital — Stanford
Identifiers
NCT: NCT07042074 · 77696