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NCT Number: NCT06924814

Technology-Based Distractions for Minor Procedures

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Procedural Anxiety Signs and Symptoms

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patient age between 4-17
  • English speaking
  • Parental consent/patient assent
  • Undergoing minor procedure(s) at LPCH or Stanford Hospital

Exclusion criteria

  • Patient does not consent
  • Legal guardian not present to obtain consent
  • Patient with a significant neurological condition or major developmental disability
  • Patient experiencing nausea
  • Patient with active infection of the face or hand
  • A history of severe motion sickness
  • A history of visual problems
  • A history of seizures caused by flashing light
  • Major surgery within the last 48 hours
  • Patients who are clinically unstable or require urgent/emergent intervention
  • Patient or parental preference for general anesthesia

Treatment and study plan

Standard of Care

Behavioral

Participant is allowed to use what they will use as a distraction tool while they are receiving treatment.

Immersive technology

Behavioral

Participants will be randomly assigned to one of the following four groups; VR headsets, a bluetooth haptic device (Buddy Guard), a screen and projector (BERT), and a tablets with a game. Participant's anxiety will be assessed and pre- and post-intervention assessments will be completed.

Primary outcomes

  1. Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures

    Time frame: baseline, immediately after the intervention

    Participants will complete the Visual Analogue Scale for Anxiety (VAS-A), a self-report scale to measure anxiety levels before and after the technological intervention. The scale is a horizontal line from 0 to 10 with an anchor at 0 indicating "no anxiety" and an anchor at 10 indicating "worst possible anxiety".

Secondary outcomes

  1. Evaluate the effectiveness of technological interventions on pain levels in patients whose age is 4-11 years old and undergo minor procedures

    Time frame: baseline, immediately after the intervention

    The FSP-R is a self-report measure of pain intensity displaying six faces representing equal intervals between the scale values from least pain = 0 to most pain = 10

  2. To evaluate pain levels pre- and post-intervention, participants will complete the Numerical Rating Pain Scale (NRPS) for patients 12-17 years old.

    Time frame: baseline, immediately after the intervention

    The NRPS quantifies pain intensity on a scale from 0, being no pain, to 10, being the worst imaginable pain.

  3. To evaluate patient's, clinician's, and caregiver's satisfaction levels

    Time frame: immediately after the intervention

    To analyze the patient's, clinician's, and caregiver's satisfaction levels, the feedback in the satisfaction survey at the end will be evaluated. The purpose of this analysis is to provide qualitative data on which aspects of the technological intervention the patient received mattered the most to the patient, clinician, and caregiver.

  4. To evaluate the patient's affect during the intervention using HRAD

    Time frame: during minor procedure

    HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation.

  5. To evaluate the patient's cooperation during the intervention using the modified Induction Compliance Checklist (mICC)

    Time frame: during minor procedure

    The mICC score will be recorded by the trained research observers during the minor procedure.11 behaviors that are commonly observed preoperatively will be recorded. Perfect compliance (score of 0) was compared to those that lacked cooperation. mICC will be rated at the time of intervention and only requires one RA.

Study contacts

Contact information is provided by the study sponsor or research team.

Man Yee Suen, MMedSc

CONTACT

[email protected]

6504970927

Thomas Caruso, MD, PhD

CONTACT

[email protected]

6504970927

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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