Cognitive Behavior Treatment, Needle Phobia, Virtual Reality
Conditions
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 (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
BEHAVIORALMixed 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 and after each session. If VAS-A score is less or equal to 5, participants will be able to proceed. If VAS-A score is greater than 5, participants will have the option to exit the study or proceed. 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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Patients between the ages of 11-17 2. Fear of needle 3. 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
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 physical disabilities that prevent them from using their hands 9. Patients with substance use disorder in past year 10. Virtual Reality headsets do not fit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety symptoms related to needle phobia and BII | Baseline, immediately after the intervention of week 4 and week 5, 6 and 12 weeks after completion of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Conductance Response Density (SCRD) | during the first intervention, week 4, week 5 and last intervention. | Change in sympathetic response to a scripted discussion regarding use of a needle and needle being shown - administered at the beginning of the first session and at the end of the last session. |
| Parasympathetic response indexed by Respiratory sinus arrhythmia (RSA) | during the first intervention, week 4, week 5 and last intervention. | Change in parasympathetic response to a scripted discussion regarding use of a needle and needle being shown. Measured via respiratory sinus arrhythmia (RSA) in hertz using chest biometric sensors in 30-second epochs. |
| Change in Anxiety after virtual 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. |
| Change in Anxiety after real exposure | during intervention, 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. |
| User engagement | Immediately after final intervention | User engagement will be measured by User Engagement Scale (UES) - Short. This scale consists of 12 items that participants will respond to, reflecting their feelings and interactions with the application or platform. Each item is rated on a Likert scale ranging from 1 to 5, where 1 indicates "strongly disagree" and 5 indicates "strongly agree." |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAaron Lulla, MD, PhD
Stanford University
Outcome results
None listed