Distracting Through Procedural Pain and Distress
Condition: Chronic Illness; Hematologic Malignancy; Bone Marrow Transplant Infection; Oncology; Sickle Cell Disease
MeSH terms: Hematologic Neoplasms; Anemia, Sickle Cell; Chronic Disease
Study type: Interventional

Summary: 
      Children with acute and chronic illness undergo frequent, painful, and distressing
      procedures. This randomized control trial was used to evaluate the effectiveness of guided
      imagery (GI) vs virtual reality (VR) on the procedural pain and state anxiety of children and
      young adults undergoing un-sedated procedures. We explored the role of trait anxiety and pain
      catastrophizing in intervention response.
    

Detailed description: 
      Treatment for pediatric cancer and blood disorders can range from several months to several
      years. During the course of treatment, children often undergo several painful and/or
      frightening procedures. Common unsedated procedures include needle access of an implanted
      central venous port (i.e., "port access") prior to receiving chemotherapy; intravenous needle
      sticks to provide chronic transfusion therapy or treatment for iron overload in patients with
      sickle cell disease; and weekly changing of the bandage (dressing) around a peripherally
      inserted central catheter (PICC). These procedures are often distressing to a pediatric
      patient. As a result, there is an emphasis on the use of non-pharmacologic interventions to
      manage symptoms of patient pain and anxiety for procedures that do not warrant pharmacologic
      intervention. There is also ample evidence to suggest that parental coping is associated with
      child distress, which highlights the need for interventions that have the potential to
      decrease parental, as well as patient, distress. Interventions that are cost-effective and
      sustainable are most appealing in the current healthcare environment.

      Non-immersive distraction, such as guided imagery, is widely regarded as useful in decreasing
      pain and anxiety during procedures. Guided imagery is a cognitive strategy that typically
      involves a staff member describing in detail a situation that is incompatible with the
      experience of pain and is meant to invoke feelings of calm. It is a commonly used
      intervention to address procedural distress and, aside from staff time, is free of cost.
      However, that the more distracting the stimuli, the greater the expenditure of cognitive
      energy, and the greater reduction in one's capacity to process pain and feel distressed. This
      leads one to question whether VR, an immersive, interactive technology that can realistically
      project three-dimensional images, may be more effective than a non-immersive distraction in
      managing procedure-related pain and distress. VR has been used to assist with procedural
      distress in several contexts over the past 15 years, including pediatric pain, burn care,
      dental procedures, and port access. Reviews of VR usage have been generally positive, with
      most studies suggesting that VR is a feasible and efficacious method of distraction that can
      reduce patient-reported and objective physiological measures of pain and distress. Effect
      sizes in the medium to the large range have been found when comparing VR to standard of care
      and non-immersive distraction (e.g., videogames), have found that subjects using VR
      distraction for pain showed more improvement than approximately 83% of control subjects.
      Other sources have highlighted positive patient satisfaction and a low incidence of negative
      side effects (e.g., motion sickness) when using VR. The cost of VR equipment has decreased
      over the years, although VR headsets still average $300-500 with additional cost for game
      controllers and smartphones/game systems. For use within a hospital, the further cost would
      need to be incurred to reduce the risk of infection for equipment that is shared.

      Using a comparative effectiveness model, this project will compare a low-cost, but widely
      accepted non-immersive distraction intervention (guided imagery) to a higher cost, but very
      promising immersive intervention (VR) in managing patient pain and anxiety, as well as parent
      distress. To our knowledge, this is the first time these two interventions will be directly
      compared. It is also the first time that parental distress will be measured as an outcome of
      a VR intervention. Hospital resource utilization (staff time, facility usage) will be
      evaluated as an additional cost/benefit aspect of the intervention.
    

Intervention name(s): Guided Imagery; Virtual Reality
Intervention type(s): Other; Other
Intervention description(s): Upon completion of study paperwork and 3-5 minutes prior to the nurse entering the room, study personnel will play an audio recording of an underwater guided imagery during one of these procedures: port access, dressing changes, and IV sticks. Guided imagery is an intervention that relies on a patient's imagination to create a sensory experience that utilizes mental images, sounds, smells, tastes, and touch. The guided imagery script used in this study describes an underwater scene and is meant to closely mimic the VR condition with the exception that it will be non-immersive. It will last approximately 15 minutes but can be played again if the procedure lasts longer than 15 minutes. Study personnel will remain in the room to record the time of the procedure, staff number, time in the room, and complete an observational measure of distress.; Upon completion of study paperwork and 3-5 minutes prior to the nurse entering the room, study personnel will assist the patient in beginning the VR intervention during one of these procedures: port access, dressing changes, and IV sticks. The VR intervention consists of interactive audio and visual underwater experience. The VR software offers both passive and active gameplay over the course of 15 minutes, which can be repeated. In the passive experience, the software moves patients through an ocean filled with sea creatures and allows them to look around and observe the underwater scene. In the active experience, patients launch balls at the fish. Patients will be encouraged but not required to actively participate; staff will record whether the patient participates in the active portion of the VR program. Study personnel will remain in the room to record the time of the procedure, staff number, time in the room, and complete an observational measure of distress.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Procedural Pain; Anxiety; Pediatric; Virtual Reality; Guided Imagery