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Technology-Based Distractions During Minor Procedures

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ClinicalTrials.gov Identifier: NCT03628989
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2018
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Samuel Rodriguez, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Anxiety Procedural Anxiety Behavioral: Use of Virtual Technology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Technology-Based Distractions In Pediatric Patients During Minor Procedures
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Cardiac Cathertization Patients
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.

Experimental: Allergy Patients
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.

No Intervention: Procedure-Only Patients



Primary Outcome Measures :
  1. Measure anxiety score [ Time Frame: Duration of procedure (usually no more than 2-4 hours) ]
    Numerical anxiety scale (0-10), 0 being no anxiety and 10 being the worst imaginable anxiety


Secondary Outcome Measures :
  1. Parent and Child Satisfaction Questionnaire [ Time Frame: Duration of procedure (usually no more than 2-4 hours) ]
    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"

  2. Virtual and Augmented Reality Feedback Survey [ Time Frame: Duration of procedure (usually no more than 2-4 hours) ]
    Measure satisfaction and feedback for Virtual Reality/ Augmented Reality in regards to software and hardware for future iterations.

  3. Asses cumulative medication dosing and the duration of procedure [ Time Frame: Duration of procedure (usually no more than 2-4 hours) ]
    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.

  4. Evaluation of Passive vs Active Interventions [ Time Frame: Duration of procedure (usually no more than 2-4 hours) ]
    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.


Other Outcome Measures:
  1. Fear assessment [ Time Frame: Duration of procedure (usually no more than 2-4 hours) ]
    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.

  2. Pain Assessment [ Time Frame: Duration of procedure (usually no more than 2-4 hours) ]
    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.

  3. Procedural Compliance [ Time Frame: Duration of procedure (usually no more than 2-4 hours) ]
    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.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 17 and under
  • Able to consent or have parental consent
  • Undergoing minor procedures (i.e lumbar punctures, cardiac catheterization) at Lucile Packard Children's Hospital (LPCH) or Stanford Hospital facilities

Exclusion Criteria:

  • People who do not consent
  • Significant Cognitive Impairment
  • History of Severe Motion Sickness
  • Current Nausea
  • Seizures
  • Visual Problems
  • Non-English Speaking
  • Patients who clinically unstable or requires urgent/emergent intervention
  • (ASA) Physical status classification class 4 or higher
  • Patient or parental preference for General Anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628989


Locations
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United States, California
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Thomas J Caruso, MD, MEd Stanford University
Principal Investigator: Samuel Rodriguez, MD Stanford University
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Responsible Party: Samuel Rodriguez, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03628989    
Other Study ID Numbers: 46917
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders