Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03690531|
Recruitment Status : Completed
First Posted : October 1, 2018
Last Update Posted : October 31, 2019
|Condition or disease||Intervention/treatment|
|Anxiety Fear Pain||Device: Take-Pause virtual reality Device: Passive Distraction|
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 :||Observational|
|Actual Enrollment :||110 participants|
|Official Title:||Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department|
|Actual Study Start Date :||November 28, 2018|
|Actual Primary Completion Date :||June 30, 2019|
|Actual Study Completion Date :||August 31, 2019|
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
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.
Device: Passive Distraction
Standard or passive distraction technique, lasting 5 minutes.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690531
|United States, New York|
|Maimonides Medical Center|
|Brooklyn, New York, United States, 11219|
|Study Chair:||John Marshall, MD||Maimonides Medical Center|