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CompletedNCT03690531Updated Oct 31, 2019

Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department

An observational study in Anxiety Fear and Pain, sponsored by Antonios Likourezos. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-10-31.

Sponsored by Antonios Likourezos · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
110
Ages
13 Years to 17 Years
Sex
All
01

Study summary

Non-pharmacological interventions including distraction techniques (ie., games, ipads, bubbles, stickers) are standard of care in reducing situation anxiety for children in the pediatric emergency department. The goal of the study is to evaluate the efficacy of a mindfulness based virtual reality (mbVR) tool (Take-Pause) for pediatric patients age > 12 years. The study team will be providing children with a virtual reality experience upon arrival to the emergency department and measuring the effectiveness of the intervention versus standard of care (Ipads, games). Subjective measurements will include questionnaires and objective measurements will include vital signs.

Read the detailed description

Emergency room visits can be a particularly stressful experience for children. It is well-known that among pediatric patients, increased anxiety and stress levels can contribute to less pain tolerance and higher pain scores. Increased levels of anxiety can also lead to difficulty communicating needs and building a good patient-provider relationship. Furthermore, higher situational anxiety may also lead to decreased patient satisfaction. Though there are pharmacologic interventions to mitigate pain and anxiety, the side effect profiles or route of administration sometimes outweigh the potential temporary benefits medication may provide. Distraction techniques have long been established in literature to help diminish pain in pediatric patients while essentially having no adverse profile. By utilizing a simple distraction such as visual or musical stimuli, providers have been able to decrease the use of anxiolytics or analgesics during pediatric care. Only a handful of controlled studies have explored distraction techniques in the pediatric emergency room, showing promising results in alleviating procedural pain/anxiety.

Immersive virtual reality has been introduced recently as an alternative distraction technique among hospitalized patients, providing a way to cope with the stressful hospital environment. Several randomized control studies have found virtual reality to significantly reduce pain in pediatric patients undergoing chronic or burn wound dressing changes. However, no studies have been done in the emergency room exploring the efficacy of virtual reality as a distraction technique, nor integrating mindfulness as part of the virtual reality experience. Mindfulness has garnered interest over the years as another powerful, but simple tool, in reducing emotional stress and increasing overall well-being of participants. An organization which has integrated mindfulness into a virtual reality program for adolescents is Take-Pause. The intervention will administer the Take-Pause immersive virtual reality simulation as a distraction technique via virtual reality goggles, headset, and iphone.

The study will be a prospective, single-blinded randomized control trial conducted in an pediatric emergency room at a single tertiary care hospital located in an urban region. The primary outcome is to decrease situational anxiety level by at least 5 points on a State Trait Anxiety Inventory scale when comparing mbVR to passive distraction technique. Secondary outcomes will look at reduction of perceived pain when utilizing the Wong-Baker FACES scale and respiratory rate or heart rate changes. Study population will consist of pediatric patients aged 13 to 17 year old presenting to the emergency room, enrolled during a 12 month period. Follow-up will be conducted at 5-min post-intervention. Exclusion criteria includes patients who have received opioid or anxiolytic pharmacologic intervention at triage or 1 hour prior to ED arrival. Patients will be randomly assigned after triage to either the mbVR or passive distraction intervention arm via a 1:1 patient allocation scheme utilizing block randomization. Baseline short STAI survey, pain scale, and vitals will be obtained during triage. The timer will begin once video starts and end when the video is complete. After 5 minutes, the patient will repeat the survey, scale, and have vitals taken. The treatment, or mbVR intervention arm will be a Take-Pause virtual reality simulation lasting 5 minutes shown through a virtual reality goggle, headset and iPhone. The control arm will consist of the standard or passive distraction technique, lasting 5 minutes. Each intervention arm will consist of 55 subjects for a total of 110 subjects.

02

Conditions studied

  • Anxiety Fear
  • Pain

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03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 110 is below the median of 353 across 714 observational studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Antonios Likourezos is the lead sponsor of 42 studies on the registry; 4 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 11 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

children between age 13 to 17 presenting to the emergency department

Inclusion criteria

  • Patients presenting to the pediatric emergency room
  • aged 13 years to 17 years
  • understand and can complete instructions in English
  • English-speaking.
  • Participants must also be conscious and not in need of immediate interventions

Exclusion criteria

Exclusion Criteria:

  • Anxiolytic or opioid analgesic given in triage,
  • developmental delay
  • seizure
  • significant visual impairment
  • hearing impairment
  • prone to motion sickness
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
110 participants (actual)
Patient registry
No

Groups and cohorts

  • Take Pause Virtual Reality Head Set

    The mbVR intervention arm will be a Take-Pause virtual reality simulation will be for 5 minutes shown through a virtual reality goggle, headset and iPhone.

    Device: Take-Pause virtual reality

  • Passive Distraction Group_IPAD

    The Passive Distraction group will utilize the standard or passive distraction technique of using an IPAD lasting 5 minutes.

    Device: Passive Distraction

Interventions

  • DeviceTake-Pause virtual reality

    Take-Pause virtual reality simulation lasting 3 minutes shown through a virtual reality goggle, headset and iPhone.

  • DevicePassive Distraction

    Standard or passive distraction technique, lasting 5 minutes.

06

What researchers measure

Primary outcomes

  1. Decrease in anxiety level

    The primary outcome is to decrease situational anxiety level by at least 5 points on a State Trait Anxiety Inventory scale when comparing mbVR to passive distraction technique. The scores range from 20 to 80 with high score indicating higher levels of anxiety.

    Time frame: 5 minutes

Secondary outcomes

  1. Reduction in pain scores

    Secondary outcomes will look at reduction of perceived pain when utilizing the Wong-Baker FACES scale ranges from 0 to 10 with 0 being no pain; 4-6 is moderate pain and 10 is severe pain.

    Time frame: 5 minutes

07

Study locations

1 site
  • Maimonides Medical Center
    Brooklyn, New York 11219, United States
08

References and documents

Publications

  • Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934. PubMed 29237632 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03690531
Lead sponsor
Antonios Likourezos
Responsible party
Antonios Likourezos (Research Manager, Maimonides Medical Center) — Sponsor-investigator
First posted
Oct 1, 2018
Start date
Nov 28, 2018
Primary completion
Jun 30, 2019
Completion
Aug 31, 2019
Last update
Oct 31, 2019

Study contacts

John Marshall, MD
study chair · Maimonides Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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