Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department
Condition: Anxiety Fear; Pain
MeSH terms: Emergencies
Study type: Observational

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.
    

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.
    

Intervention name(s): Take-Pause virtual reality; Passive Distraction
Intervention type(s): Device; Device
Intervention description(s): Take-Pause virtual reality simulation lasting 3 minutes shown through a virtual reality goggle, headset and iPhone.; Standard or passive distraction technique, lasting 5 minutes.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children between age 13 to 17 presenting to the emergency department