Efficacy of Virtual Reality in Pain Reduction in Orthopedic Pediatric Patients
Condition: Orthopedic Disorder; Fractures, Bone
MeSH terms: Musculoskeletal Diseases; Fractures, Bone
Study type: Interventional

Summary: 
      To prospectively determine if pediatric patients undergoing orthopedic procedures can benefit
      from employing virtual reality for pain management.
    

Detailed description: 
      INTRODUCTION

      Pediatric patients are exposed to procedures that can result in pain and anxiety. The
      International Association Study of Pain 2011 defines pain as an unpleasant sensory and
      emotional experience associated with actual or potential tissue damage. Pharmacological
      interventions have been used but consequences of this therapy, specifically opioids, are of
      concern. Distraction techniques have been implemented recently but there is a significant
      range of these techniques such as breathing, music, and play therapy, among others.

      Some studies indicate child preferences and temperament can optimize outcomes in regards to
      therapy. Non-pharmacological analgesics have been shown to benefit patients overall. Watching
      videos, biofeedback, mental imagery, and hypnosis have all been reported to have analgesic
      effects in the literature. Additionally cognitive behavioral strategies particularly
      distraction have been shown to reduce pain reports as high as 85% of patients. The most
      recent emerging technique is virtual reality.

      Virtual reality creates the illusion that user is immersed in another environment. A three
      dimensional world is seen through the eyepieces, and the user can interact with the world in
      several ways: by moving their head and neck to look around the environment and a hand held
      trigger allows you to shoot at objects within the environment. Because this is a more
      interactive environment and more attention capturing than simple distractions, VR is thought
      to be more beneficial than basic distraction techniques. Additionally, using a head-mounted
      display (HMD) prevents visual perception of the real world, decreasing the chance of
      distraction. Previous uses of distraction show that children only pay attention to the
      distraction for 2/3 of the procedure, but virtual reality prevents the distraction of the
      procedure's visual stimuli.

      In this study the investigators will attempt to determine the benefit of using virtual
      reality distraction techniques with a head-mounted display in standard orthopedic
      consultations that involve pain. The literature review indicates that excepting burns, this
      study has not been performed previously. Additionally heart rate monitoring has not been
      previously been included in the analysis of pain reduction. The investigators will assess
      pain reduction using patient feedback and pain scales, but also heart rate monitoring
      pre-procedure, during procedure, and post-procedure. In this study, the only procedure will
      be cast removal.

      OBJECTIVE

      To prospectively determine if pediatric patients undergoing orthopedic procedures can benefit
      from employing virtual reality for pain management.

      SPECIFIC AIMS

      To identify any benefits from virtual reality use as pain management in the pediatric
      population by means of patient feedback and by heart rate monitoring during orthopedic care.
      By doing this we can determine if virtual reality should become a standard of care in pain
      management for the pediatric population.

      RATIONALE AND SIGNIFICANCE Post-surgical pain has been reported to be difficult to manage and
      can potentially limit outcomes in the pediatric population. Pharmacologic management is not
      ideal and intolerable for some patients. In 2009, a study of 182 children in the burns and
      orthopedic department at Royal Children's Hospital, Brisbane, Australia, found that
      multimodal distraction devices (MMD) reduced pain and anxiety significantly as well as
      reduced future procedural pain. Multimodal devices are interactive devices that prepare the
      child for a procedure and uses developmentally appropriate distraction stories and games to
      alleviate the pain. Virtual reality provides an alternative method with high rewards.

      In a case study of post-surgical twice-daily physiotherapy regimen, using a subjective pain
      scale, it was found to reduce pain by 41.2% compared to the control patients. Studies looking
      at IV placement with VR in children suggest satisfaction for children, parents, and nurses.
      That study suggested analyzing affective pain, anxiety, overall satisfaction, and pain
      intensity. A literature review from 2008-2013 also found that distraction techniques would be
      a simple and efficient non-pharmacological acute pain relief strategy and should be
      implemented in pediatric care settings. It suggested further exploring the use of virtual
      reality, which was emerging at the time.

      Virtual reality distraction has also been used in chemotherapy, during burn wound care,
      intravenous port access in pediatric patients, to reduce pain and anxiety for invasive
      medical procedures, to help adolescents with cerebral palsy endure physiotherapy, and to
      reduce preoperative anxiety. Another study of VR during routine blood draw, found that VR was
      more effective than the standard of care for reducing pain and anxiety. They determined VR
      has the capacity to act as a preventive intervention transforming the blood draw experience
      into a potentially pain-free routine medical procedure particularly for patients with high
      anxiety. VR has the potential to both reduce outcomes for children but also reduce distress
      in their caregivers.

      Uncontrolled pain is thought to have serious psychological and physiological consequences,
      including an increased risk of morbidity and even mortality in children. Recent estimates
      have shown that around 27% of children experience moderate to severe pain in the hospital;
      teenagers and infants experience higher amounts of 38% and 32% respectively. Pediatric
      patients with untreated pain are more susceptible to developing sensitization, hyperalgesia,
      chronic pain, and allodynia. Long-term effects can include alterations in circuitry that
      impact pain processing in the future which predispose to decreased sensitivity or
      hypersensitivity to painful stimuli.

      METHODS/PROCEDURE

      Patients who present to have a cast removed, percutaneous bone pin removed, or cast applied
      will undergo heart rate monitoring via a pulse oximeter and give feedback post-procedure.
      Patients will be selected if they are between the ages of 5 and 18 years of age, have no
      significant co-morbidities, and are not undergoing an emergent procedure. Approximately 100
      patients will be enrolled in the study, with 50 participants in each of two groups. The two
      groups will be the intervention group- those with the VR headset, and a control group- those
      without a VR headset. The groups will be randomized, and demographic data including age and
      sex will be obtained. Patients who qualify for the study will be consented by a member of the
      study team during the visit.

      The two groups will be randomized via GraphPad software through
      https://www.graphpad.com/quickcalcs/randomize2/. The website will randomly assign 50 subjects
      each to two groups, for a total of 100 subjects. The results will be copied into a secure
      computer database to keep track of the assigned groups. Patients will be assigned a study
      number from 001 through 100, according to the chronological order in which they are
      consented. From there, the investigators will match up the patient's study number with the
      results from GraphPad and determine the patient's group assignment.

      Enrolled patients will be located at the Ochsner Medical Center, New Orleans, Louisiana.
      There will be no charges to the patient and no reduction of patient care. If the patient
      requires admission for management of their pain, they will be admitted to the inpatient unit
      and followed by the team. Patients will undergo heart rate monitoring before, during, and
      after the cast removal procedure. All patient data collected will be de-identified and stored
      on a secured database.

      We will analyze our data with T-tests with 2-tailed and 2-sample unequal variance as the
      parameters.

      PROTOCOL

      This study will involve patients in the pediatric orthopedic setting at Ochsner Medical
      Center in New Orleans, Louisiana. This will be a prospective consecutive case series to
      evaluate the severity and reduction of pain in the pediatric population.

      Randomization of study groups will be performed prior to any patient enrollment. There will
      be two study groups with approximately 50 subjects in each group. Participants in group 'A'
      will be fitted with the VR headset during their procedure. Participants in group 'B' will not
      be fitted with the VR headset and they will act as the control group. Prior to enrollment in
      this study, all patients will be properly informed and consented about the requirements,
      risks, benefits, and other relevant information of the study.

      Patients will experience the standard of care and any abnormalities or distress will be
      addressed. If the patients require admission for pain management, they will be admitted to
      Ochsner Medical Center. Patients will continue to be monitored for the utmost patient care.
      The anticipated number of participants in the study is about 100 patients.

      All factors between the groups will be kept as similar as possible with any changes being
      formally documented. Patients will be given follow-up instructions that are consistent with
      the standard of care for cast removal. It is our goal to determine if virtual reality should
      become a standard of care in the pediatric population in regard to orthopedic procedures.
    

Intervention name(s): Virtual Reality Headset and handheld remote control.
Intervention type(s): Behavioral
Intervention description(s): Brand name: Oculus Quest
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A non-blinded computer-randomized prospective trial with two parallel study groups.
Masking: None (Open Label)
Primary purpose: Supportive Care