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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

Tracking Information
First Submitted Date  ICMJE July 31, 2018
First Posted Date  ICMJE August 14, 2018
Last Update Posted Date August 14, 2020
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
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 2
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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"
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 11, 2020)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Technology-Based Distractions During Minor Procedures
Official Title  ICMJE Evaluation of Technology-Based Distractions In Pediatric Patients During Minor Procedures
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Anxiety
  • Procedural Anxiety
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Cardiac Cathertization Patients
    Participants will use technology based distraction during procedure.
    Intervention: Behavioral: Use of Virtual Technology
  • Experimental: Allergy Patients
    Participants will use technology based distraction during procedure
    Intervention: Behavioral: Use of Virtual Technology
  • No Intervention: Procedure-Only Patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03628989
Other Study ID Numbers  ICMJE 46917
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samuel Rodriguez, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas J Caruso, MD, MEd Stanford University
Principal Investigator: Samuel Rodriguez, MD Stanford University
PRS Account Stanford University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP