Technology-Based Distractions During Minor Procedures

Not Applicable

Completed

• Conditions: Anxiety; Procedural Anxiety; Pain
• Interventions: Behavioral: Use of Virtual Technology

• Registration Number: NCT03628989
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-14
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac Cathertization Patients	Use of Virtual Technology	Participants will use technology based distraction during procedure.
Allergy Patients	Use of Virtual Technology	Participants will use technology based distraction during procedure

Primary Outcome Measures

Name	Time	Method
Measure anxiety score	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

Name	Time	Method
Asses cumulative medication dosing and the duration of procedure	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.
Virtual and Augmented Reality Feedback Survey	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.
Parent and Child Satisfaction Questionnaire	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"
Evaluation of Passive vs Active Interventions	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.

Trial Locations

Locations (1)

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States