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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) + Extended reality exposure therapy (XRET) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixed reality (XR) Exposure Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety symptoms related to needle phobia and BII | 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. | Baseline, immediately after the intervention of week 4 and week 5, 6 and 12 weeks after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Conductance Response Density (SCRD) | 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. | during the first intervention, week 4, week 5 and last intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aaron Lulla, MD | Contact | 310-478-3711 | alulla@stanford.edu | |
| Thomas Caruso, MD, PhD | Contact | 6504970927 | tjcaruso@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aaron Lulla, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Parkard Children's Hospital | Stanford | California | 94304 | United States |
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| ID | Term |
|---|---|
| D007171 | Implosive Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Parasympathetic response indexed by Respiratory sinus arrhythmia (RSA) |
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. |
| during the first intervention, week 4, week 5 and last intervention. |
| Change in Anxiety after virtual exposure | 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. | Baseline, immediately after the intervention |
| Change in Anxiety after real exposure | 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. | during intervention, immediately after the intervention |
| User engagement | 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." | Immediately after final intervention |