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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03690531
Other study ID # 2018-05-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 28, 2018
Est. completion date August 31, 2019

Study information

Verified date September 2018
Source Maimonides Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Take-Pause virtual reality
Take-Pause virtual reality simulation lasting 3 minutes shown through a virtual reality goggle, headset and iPhone.
Passive Distraction
Standard or passive distraction technique, lasting 5 minutes.

Locations

Country Name City State
United States Maimonides Medical Center Brooklyn New York

Sponsors (1)

Lead Sponsor Collaborator
Antonios Likourezos

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 5 minutes
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