Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department

Pain Clinical Trial

Official title:

Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690531
• Other study ID #: 2018-05-04
• Status: Completed
• 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
• 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Fear
• Emergencies
• Pain

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