Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool
Condition: Acute Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study will evaluate Panda, a smartphone-based pain assessment tool. During a child's
      recovery from surgery, a Post-Anesthetic Care Unit nurse will assess their pain, which helps
      determine what medication they need. Traditionally, this involves asking the child to rate
      their pain on a scale from 1 to 10, by moving a slider along a coloured scale or pointing to
      one of a series of faces on a piece of card. The Panda uses the same methods, but presents
      them on a smartphone screen. Our evaluation will ensure that the Panda gives the same pain
      scores as the traditional methods.
    

Detailed description: 
      The purpose of this study is to ensure that Panda, a smartphone-based pain assessment tool,
      can be used effectively by children after surgery and that the pain scores it obtains agree
      with the scores obtained using traditional methods of pain assessment. In particular the aim
      is to show agreement (a) between pain scores obtained using Panda and pain scores obtained
      using the Faces Pain Scale-Revised for 4-12 year olds and (b) between pain scores obtained
      using Panda and pain scores obtained using the Coloured Analogue Scale (CAS) for 5-18 year
      olds.

      We will recruit children between 4 and 18 years old, in general good health, who are
      scheduled for surgery. We will exclude any child who has a psychiatric diagnosis,
      developmental delay or brain injury, significant visual impairment or psychomotor
      dysfunction.

      This study is taking place in the Post-anesthetic Care Unit (PACU) at BC Children's Hospital.
      We will recruit 200 children in total. The study procedures include the following:

      Stage 1 - pre-clinical usability study: we will conduct a series of participatory design
      sessions with nurses in the PACU and with 20 children in the Surgical Day Care Unit (SDCU)

      Stage 2 - clinical validation study: children will be asked to rate their pain using both the
      Panda and a traditional tool (which is used first will be decided randomly); during this
      stage, children will also be asked their opinion (e.g. which tool they preferred using and
      about any problems they experienced using either tool).

      All scores will be recorded on the Panda device and extracted at the end of each day. No pain
      medication will be administered on the basis of a pain score obtained using the Panda.

      Panda will be compared with the traditional method (FPS-R and CAS) within 3 different age
      groups (4-8, 8-12 and 12-18), using the following criteria: practicality, based on failure
      rates in obtaining pain scores from Panda compared with traditional method; preference for
      Panda compared with traditional method; agreement between the Panda score and the traditional
      score.
    

Intervention name(s): Panda first followed by manual pain assessment; Manual first followed by Panda pain assessment
Intervention type(s): Device; Device
Intervention description(s): Panda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Panda will be used first, manual method 5 mins later.; Panda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Manual method will be used first, Panda 5 mins later.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic