Virtual Reality vs Passive Distraction for Pain Management
Condition: Virtual Reality; Pain; Pain Perception; Pain Management; Anxiety; Catastrophizing, Pain; Stress
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Background: Outpatient pediatric orthopedic procedures such as percutaneous pins removal and
      sutures are considered painful and generate significant stress and anxiety in children.
      However, given their short duration and the need for a quick turnover in outpatient clinics,
      there are very few interventions aimed at relieving pain, stress and anxiety related to these
      procedures. Neither simple analgesia nor topical anesthetics proved effective for procedural
      pain reduction with this population. Moreover, narcotics and procedural sedation do not
      appear to be feasible alternatives as they require surveillance, prolonging visit to the
      outpatient clinic and generating several undesired side effects. Therefore, it would be
      imperative to explore non-pharmacological pain management methods as they require minimal
      preparation and do not usually generate any side effects.

      Aim: To examine the effect of virtual reality (VR) compared to passive distraction, on pain,
      stress, anxiety and memory of pain in children undergoing a percutaneous pin removal
      procedure or sutures in an outpatient orthopedic clinic.

      Hypothesis: VR distraction provides better pain relief during percutaneous pin removal
      procedures or sutures than passive distraction, in children from 7 to 21 years old.

      Methods: The study will be a prospective randomized controlled trial with parallel groups.
      Children from 7 to 21 years old, visiting the clinic for follow up and percutaneous pin
      removal procedure or sutures, accompanied by a parent or legal guardian will be recruited.
      The experimental group will receive a VR distraction through a head-mounted Oculus Quest® and
      the control group will receive passive distraction through watching a video on an iPad®. The
      primary outcome will be the mean pain score after the procedure (self-report of pain level
      during the procedure) measured by the Numerical Rating Scale (NRS). Anxiety will be measured
      by the Child Fear Scale (CFS) and stress will be measured using level of salivary
      Alpha-Amylase before and 10-min after the procedure. Memories of pain and anxiety will be
      measured one week after the procedure using the same scales (NRS and CFS). The investigators
      aim to recruit 188 children.

      Discussion: The investigators believe that results of this study will allow to improve pain,
      stress and anxiety management practices in this orthopedic clinic by showing that
      non-pharmacological interventions can be done, at very low cost, to improve the experience of
      the child undergoing these painful procedures through an innovative and more humanistic
      approach.
    

Detailed description: 
      BACKGROUND

      In children, many fractures treated surgically will be stabilized percutaneously with
      Kirschner wires and some will require sutures to help the surgical wound to heal. When the
      fracture is adequately healed, the percutaneous wires and/or the sutures are generally
      removed in the outpatient clinic. These procedures represent a potential source of pain,
      stress and anxiety for the patient, as well as for the parents and the caregivers.

      A study looked at different types of analgesia during percutaneous pin removal comparing
      Acetaminophen, Ibuprofen and placebo but no clinically nor statistically significant
      difference was found among the three groups. Another study compared topical liposomal
      lidocaine to a placebo but found no statistically significant difference in postprocedure
      pain scores between groups. On the other hand, administration of narcotics or procedural
      sedation for pin removal procedure probably exceeds the real needs for the majority of
      patients. Adding the fact that the administration of narcotics or procedural sedation
      requires monitoring post administration, those options lengthen visit time, reduce
      significantly the efficiency in an outpatient clinic setting and are not recommended for
      routine administration.

      In contrast, there seems to be some emerging evidence about distraction methods such as
      distraction techniques facilitated by a hospital play specialist for pin removal procedures.
      Distraction use for children in orthopedic outpatient clinics has been reported anecdotally
      in some literature but, to our knowledge, has never been formally assessed in a randomised
      controlled trial. Exploring non-pharmacological interventions, including distraction, could
      be a promising venue for pain management in this population as they are simple, practical,
      easily implementable and usually without side effects.

      Virtual Reality (VR) is a distraction method that allows the user to interact with an
      immersive environment generated by a computer stimulating different senses. A review of
      studies on VR, mostly conducted with adult burn patients, showed a 35 to 50% reduction in
      procedural pain while using VR. Its positive effect has also been reported on anxiety and
      general distress during painful medical procedures in children and in adults such as
      venipuncture, wound care, chemotherapy, dental procedures, etc. A recent
      randomized-controlled trial comparing VR and standard distraction in children undergoing
      blood drawn procedures, demonstrated a significant positive effect of VR on pain and anxiety
      reduction as well as patients', caregivers' and phlebotomist's satisfaction. The authors also
      concluded that VR was more effective for children with higher anxiety sensitivity, adding
      another plus value to this new technology in children's care.

      There is evidence to suggest that reducing procedural pain and distress in the short-term,
      will have long lasting effects on children's pain and health trajectories in the long-term.
      The effect of pain on a developing child does not end after painful procedures end; how
      children remember these experiences can have long lasting effects. Children who recall pain
      in negatively-biased ways experience more pain and distress at future pain experiences and
      are at risk for developing persistent pain problems and fears and avoidance of medical care.
      Importantly, children (and parents) who are more anxious and distressed prior to painful
      medical procedures, and who experience higher pain during medical procedures, are the very
      children who develop these negatively biased recalls. Therefore, we will also examine the
      effect of VR distraction, a more immersive intervention, on children's later recall of pain.
      This is innovative as we did not find any other studies using VR and collecting data on pain
      and anxiety recalls in children following painful medical procedures. Further, we will
      compare salivary Alpha-Amylase levels between groups, which is a reliable and valid surrogate
      marker of stress that increases in response to physical and psychological stressful
      conditions such as experience of medical procedures.

      Considering the lack of optimal pain, stress and anxiety management during pin removal and/or
      removal or sutures, and the positive effect of VR for painful procedures, combining VR to
      pin/sutures removal procedures may show promising results. To our knowledge, no other studies
      have tested the effect of VR distraction via Oculus Quest® for procedural pain management in
      children undergoing painful orthopedic procedures such as percutaneous pins removal and
      removal of sutures.

      AIM & STUDY OBJECTIVES

      Primary objective: To determine if VR distraction provides better pain relief during
      percutaneous pin removal procedures and/or removal of sutures, than passive distraction, in
      children from 7 to 21 years old.

      Secondary Objectives:

        1. To determine if VR distraction provides better anxiety and stress relief in children
           during percutaneous pin removal procedures and/or removal of sutures than passive
           distraction.

        2. To determine if children receiving VR distraction will remember less pain and anxiety
           than children receiving passive distraction during the percutaneous pin removal
           procedure and/or removal of sutures.

        3. To compare the occurrence of side effects between VR distraction and passive distraction
           groups.

        4. To compare healthcare professionals' satisfaction levels between VR distraction and
           passive distraction.

        5. To compare children and parents' satisfaction levels between VR distraction and passive
           distraction.

        6. To compare requirement for rescue analgesia between VR distraction and passive
           distraction.

        7. To compare mean levels of physiological stress between groups (Levels of salivary
           Alpha-Amylase - Surrogate marker of stress)

      METHODS

      Design: Multi-center randomized controlled trial using a parallel design with two groups: a)
      experimental group (virtual reality), b) active comparator (videogame on an iPad®).

      Sample and Setting: Recruitment will be done through convenience sampling at the orthopedic
      outpatient day clinic at CHU Ste-Justine, and at the Shriners Hospital for Children and the
      Montreal Children's Hospital.

      Measures and outcomes: Timepoints. Data will be collected by the research assistant at the
      following study times: before the procedure to establish baseline (T0), immediately after the
      procedure (T1), and one week after the procedure (T2).

      Sample Size: Group sample sizes of 94 and 94 (188 in total) are necessary to achieve 80%
      power to reject the null hypothesis of equal means when the population mean difference for
      pain is 1.5 with a standard deviation for both groups of 3.3 and a significance level (alpha)
      of 2.5% using a two-sided t-test. Group sample sizes of 67 and 67 (134 in total) are
      necessary to achieve 80% power to reject the null hypothesis of equal means when the
      population mean difference for anxiety is 0.7 with a standard deviation for both groups of
      1.3 and a significance level (alpha) of 2.5% using a two- sided t-test. Based on our pilot's
      study data, there were no attrition. No interim analysis will be conducted.

      Data analysis plan: Descriptive statistics will be used to present sociodemographic and
      clinical data as well as parents, children and healthcare professionals' levels of
      satisfaction. Primary analyses: An ANCOVA adjusted for centers and baseline (T0) pain score
      measurement/anxiety score measurement will be used to assess the mean difference in pain
      scores on the NRS scale/the mean difference in anxiety scores on the CFS, between the
      experimental and the control groups at T1. Analyses will be carried out according to the
      intention-to-treat principle, with a significance level (α) of 0.025. Secondary analyses:
      Secondary analyses using ANCOVA adjusted for centers and pain score measurement/anxiety score
      measurement at T1 will be used to assess the mean difference in pain memories/anxiety memory
      between the experimental and the control groups at T2. An ANOVA adjusted for centers will be
      used to assess mean differences in children-reported pain on the GRS between the experimental
      and the control groups at T1. Correlations will be calculated to compare stress level between
      groups. Cochran-Mantel-Haenszel tests will be conducted to compare dichotomous variables
      including the occurrence of side effects, use of rescue analgesia, and use of other
      non-pharmacological interventions in each group.
    

Intervention name(s): Passive Distraction; Virtual Reality Distraction
Intervention type(s): Device; Device
Intervention description(s): Patients in this group will be offered an iPad® showing a video while they will undergo their pins' removal and/or removal of sutures. There will be videos appropriate for each age group. The child can choose from the videos presented on the iPad® and start watching 5 minutes before the beginning of the procedure to assure similar preparation for both groups.; Patients in this group will be offered virtual reality distraction through the use of Oculus Quest® while they undergo their pins' removal and/or removal of sutures. VR produces a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness symptoms such as nausea, vomiting, headache. The videogame was developed by our team with three levels of difficulty, and approved by pediatric healthcare professionals. The game, oculus head-mounted device and computer will be available in the procedure room and ready for immediate use. The head-mounted device will be adjusted to the head of the child before any procedure and a period of 5 minutes will be allotted prior to pin and/or suture removal in order for the child to get acquainted with the game and immersed in the virtual environment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel/2 groups
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual reality; Immersive distraction; Virtual world; Virtual environment; Passive distraction; Procedural pain; Procedural anxiety; Acute pain; Pain management; Anxiety; Children, Child; Kid, Kids; Pediatric, Pediatrics; Young children; Orthopedics; Kirschner wire, K pin; Bone wires; Percutaneous pins; Non-pharmacological; Clinical Research; Nursing Practice; User-computer interface; Pediatric Nursing; Hospital, Pediatric; Sutures; Stress