Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department

NCT03690531 | Completed

• 1 other identifier: 2018-05-04
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Fear; Pain

Outcome Measures

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.

  5 minutes

Secondary Outcomes (1)

• Reduction in pain scores

  5 minutes

Study Arms (2)

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

Take-Pause virtual reality DEVICE

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

Take Pause Virtual Reality Head Set

Passive Distraction DEVICE

Standard or passive distraction technique, lasting 5 minutes.

Passive Distraction Group_IPAD

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children between age 13 to 17 presenting to the emergency department

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (1)

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

  PMID: 29237632 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• John Marshall, MD

  Maimonides Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: October 1, 2018
• Study Start: November 28, 2018
• Primary Completion: June 30, 2019
• Study Completion: August 31, 2019
• Last Updated: October 31, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)