Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 13 - 17 |
| Updated: | 12/5/2018 |
| Start Date: | November 28, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Antonios Likourezos, MA,MPH |
| Email: | alikourezos@maimonidesmed.org |
| Phone: | 718-283-6896 |
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.
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.
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.
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.
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
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