Technology-Based Distractions During Minor Procedures

Pain Clinical Trial

Official title:

Evaluation of Technology-Based Distractions In Pediatric Patients During Minor Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628989
• Other study ID #: 46917
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 11, 2023

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 11, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Procedural Anxiety

Intervention

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.

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Duration of procedure (usually no more than 2-4 hours)
Other	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.	Duration of procedure (usually no more than 2-4 hours)
Other	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.	Duration of procedure (usually no more than 2-4 hours)
Primary	Measure anxiety score	Numerical anxiety scale (0-10), 0 being no anxiety and 10 being the worst imaginable anxiety	Duration of procedure (usually no more than 2-4 hours)
Secondary	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"	Duration of procedure (usually no more than 2-4 hours)
Secondary	Virtual and Augmented Reality Feedback Survey	Measure satisfaction and feedback for Virtual Reality/ Augmented Reality in regards to software and hardware for future iterations.	Duration of procedure (usually no more than 2-4 hours)
Secondary	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.	Duration of procedure (usually no more than 2-4 hours)
Secondary	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.	Duration of procedure (usually no more than 2-4 hours)