Use of Augmented Reality and Virtual Reality During Cognitive Behavioral Therapy for Needle Phobia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-17
SponsorStanford University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Mixed reality (XR) Exposure Therapy
BehavioralParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cognitive Behavioral Therapy (CBT) + Extended reality exposure therapy (XRET)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, immediately after the intervention of week 4 and week 5, 6 and 12 weeks after completion of treatmentSecondary outcomes
1
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.
Time frame
during the first intervention, week 4, week 5 and last intervention.2
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.
Time frame
during the first intervention, week 4, week 5 and last intervention.3
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.
Time frame
Baseline, immediately after the intervention4
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.
Time frame
during intervention, immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov
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