Technology-Based Distractions During Minor Procedures

NCT03628989 | Completed

• 1 other identifier: 46917
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety; Procedural Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Parent and Child Satisfaction Questionnaire

  Duration of procedure (usually no more than 2-4 hours)

• Virtual and Augmented Reality Feedback Survey

  Duration of procedure (usually no more than 2-4 hours)

• Asses cumulative medication dosing and the duration of procedure

  Duration of procedure (usually no more than 2-4 hours)

• Evaluation of Passive vs Active Interventions

  Duration of procedure (usually no more than 2-4 hours)

Other Outcomes (3)

• Fear assessment

  Duration of procedure (usually no more than 2-4 hours)

• Pain Assessment

  Duration of procedure (usually no more than 2-4 hours)

• Procedural Compliance

  Duration of procedure (usually no more than 2-4 hours)

Study Arms (3)

Cardiac Cathertization Patients

EXPERIMENTAL

Participants will use technology based distraction during procedure.

Behavioral: Use of Virtual Technology

Allergy Patients

EXPERIMENTAL

Participants will use technology based distraction during procedure

Behavioral: Use of Virtual Technology

Procedure-Only Patients

NO INTERVENTION

Interventions

Use of Virtual Technology BEHAVIORAL

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.

Allergy Patients; Cardiac Cathertization Patients

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Thomas J Caruso, MD, MEd

  Stanford University

  PRINCIPAL INVESTIGATOR

• Samuel Rodriguez, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 14, 2018
• Study Start: June 1, 2018
• Primary Completion: June 30, 2023
• Study Completion: July 11, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)