An interventional study of Use of Virtual Technology in Pain, Anxiety and Procedural Anxiety, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged Up to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 58 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
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Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
Participants will use technology based distraction during procedure.
Behavioral: Use of Virtual Technology
Participants will use technology based distraction during procedure
Behavioral: Use of Virtual Technology
If parent and child consent to be in the study, the clinician will offer the use of one of the technologies: Virtual Reality (VR) headset or Augmented Reality (AR) headset. Active content includes video games, interactive avatars, and interactive experiences, while passive content includes video clips and movies. All patients will be offered the opportunity to use these technologies during their minor procedures if they meet eligibility criteria. Those who decline or who are switched over to the standard of care due to patient preference, health providers monitoring and assessment during the procedure will be noted in the database.
Measure anxiety score
Numerical anxiety scale (0-10), 0 being no anxiety and 10 being the worst imaginable anxiety
Time frame: Duration of procedure (usually no more than 2-4 hours)
Parent and Child Satisfaction Questionnaire
Parent and child questionnaire with 5 questions asking the individual on a scale from 1-5 how much they agree with each statement (1=Not at all, 3=A little bit, 5=A lot). It has stamens such as "Having the technology made me feel more relaxed before my procedure" or "If I ever have procedure again, I would like to use this technology"
Time frame: Duration of procedure (usually no more than 2-4 hours)
Virtual and Augmented Reality Feedback Survey
Measure satisfaction and feedback for Virtual Reality/ Augmented Reality in regards to software and hardware for future iterations.
Time frame: Duration of procedure (usually no more than 2-4 hours)
Asses cumulative medication dosing and the duration of procedure
Measure dosing requirements for anxiolytic and/or analgesic medications for participants thought their procedure. We will then compare these doses to their own historical chart data, since many of these patents come in routinely, and use their own data for intra-reliability measures.
Time frame: Duration of procedure (usually no more than 2-4 hours)
Evaluation of Passive vs Active Interventions
There is variation in the immersive technology experiences (active vs passive content), as a part of the study the investigators also aim to evaluate the degree of cognitive load which is suitable for clinical applications during minor procedures. During the participants immersive experience in either AR or VR, there are embedded questions in the experience that can gage as to the patient's emotional status (happy, sad, mad) or VAS scales (0-10, 0=no pain, 10=worst imaginable pain) that can let the research personnel know if we need to increase the cognitive load. If patients are self-reporting higher VAS scores, or aversive emotional status (i.e mad) the cognitive load will be increased to enhance the distraction experience from the procedure.
Time frame: Duration of procedure (usually no more than 2-4 hours)
Fear assessment
Patient's fear will be assessed through the Children's Fear Scale (CFS). Patients will be shown faces showing different levels of anxiety on a scale from 0 to 4. The left-most face (minimum value of 0) shows no anxiety at all and the right-most face shows extreme anxiety (maximum value of 4). Patients look at these faces and choose the one that shows how much anxiety was felt during procedure. This will be done only for allergy patients.
Time frame: Duration of procedure (usually no more than 2-4 hours)
Pain Assessment
Patient's pain will be assessed through the Wong-Baker FACES pain rating scale from 0 to 10. The left-most face has a value of 0 meaning no pain/doesn't hurt at all and the right-most face has a value of 10 being a lot of pain/hurts as much as you can imagine. Patients will be asked which face best describes their pain levels during the procedure. This will only be done for allergy patients.
Time frame: Duration of procedure (usually no more than 2-4 hours)
Procedural Compliance
Procedural compliance is measured through modified Induction Compliance Checklist (ICC). All behaviors observed in checklist are marked. Total score is the number of categories checked, perfect score is 0. This will only be done for allergy patients.
Time frame: Duration of procedure (usually no more than 2-4 hours)
Plan to share: No
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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