Back to resultsTechnology-Based Distractions During Minor Procedures
Primary Purpose
Pain, Anxiety, Procedural Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of Virtual Technology
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility 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
Sites / Locations
- Lucile Packard Children's Hospital Stanford
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Cardiac Cathertization Patients
Allergy Patients
Procedure-Only Patients
Arm Description
Participants will use technology based distraction during procedure.
Participants will use technology based distraction during procedure
Outcomes
Primary Outcome Measures
Measure anxiety score
Numerical anxiety scale (0-10), 0 being no anxiety and 10 being the worst imaginable anxiety
Secondary Outcome Measures
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"
Virtual and Augmented Reality Feedback Survey
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03628989
Brief Title
Technology-Based Distractions During Minor Procedures
Official Title
Evaluation of Technology-Based Distractions In Pediatric Patients During Minor Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Procedural Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac Cathertization Patients
Arm Type
Experimental
Arm Description
Participants will use technology based distraction during procedure.
Arm Title
Allergy Patients
Arm Type
Experimental
Arm Description
Participants will use technology based distraction during procedure
Arm Title
Procedure-Only Patients
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Use of Virtual Technology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure anxiety score
Description
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)
Secondary Outcome Measure Information:
Title
Parent and Child Satisfaction Questionnaire
Description
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)
Title
Virtual and Augmented Reality Feedback Survey
Description
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)
Title
Asses cumulative medication dosing and the duration of procedure
Description
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)
Title
Evaluation of Passive vs Active Interventions
Description
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)
Other Pre-specified Outcome Measures:
Title
Fear assessment
Description
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)
Title
Pain Assessment
Description
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)
Title
Procedural Compliance
Description
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)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Caruso, MD, MEd
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel Rodriguez, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Technology-Based Distractions During Minor Procedures
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