- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03690531
Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
New York
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Brooklyn, New York, United States, 11219
- Maimonides Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- Anxiolytic or opioid analgesic given in triage,
- developmental delay
- seizure
- significant visual impairment
- hearing impairment
- prone to motion sickness
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Take-Pause virtual reality simulation lasting 3 minutes shown through a virtual reality goggle, headset and iPhone.
|
Passive Distraction Group_IPAD
The Passive Distraction group will utilize the standard or passive distraction technique of using an IPAD lasting 5 minutes.
|
Standard or passive distraction technique, lasting 5 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in anxiety level
Time Frame: 5 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in pain scores
Time Frame: 5 minutes
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-05-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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