Creating a Czech Version of the Simplified Faces Pain Scale and the Simplified Concrete Ordinal Pain Scale
Condition: Pain Measurement
MeSH terms: Facial Pain
Study type: Observational

Summary: 
      The aim is to create a Czech version of pain assessment tools in children, the Simplified
      Faces Pain Scale (S-FPS) and the Simplified Concrete Ordinal Scale (S-COS), including
      methodology for their use in practice, and to establish their validity and reliability in
      pre-school children. The S-FPS is composed of three faces representing three different levels
      of pain, and the S-COS shows three blocks that symbolize three levels of intensity of pain.
      The instrument translation and linguistic validation process will be based on the
      International Society for Pharmacoeconomics and Outcomes Research guidelines (Wild et al.,
      2005). Validity and reliability will be tested by comparing the children´s pain intensity
      using the S-FPS and S-COS, which will be completed by the children, and the instrument Face,
      Legs, Activity, Cry, Consolability (FLACC), which will be completed independently by the
      attending nurse and the researcher. A repeated measures design will be used as all
      assessments will be performed prior to a painful procedure (peripheral venepuncture) and will
      be repeated twice after the painful procedure, once immediately after the painful procedure
      and a second time 5-10 minutes after the painful procedure. A total of 180 children with will
      be recruited (aged 3-6 years) from whom complete data will be obtained.
    

Detailed description: 
      Introduction:

      For a long time, there has been a myth that children do not remember pain that they were
      subjected to in the past. However, it has been confirmed that children transfer their
      negative experience of pain to adulthood. As many studies have shown, information about pain
      can be obtained from patient self-report, physical response and/or behavioral manifestations.
      Self-report is considered as the gold standard. The major problem is that most preschool-aged
      children do not have the necessary cognitive development to use the standard scales.

      A group of experts in Canada has developed two new pain scales for this particular age, the
      Simplified Faces Pain Scale (S-FPS) and the Simplified Concrete Ordinal Scale (S-COS). The
      S-FPS consists of three faces representing three levels of pain intensity, and the S-COS
      consists of three blocks that symbolize pain intensity, ranging from mild pain (one block) to
      severe pain (three blocks). Their research was based on the assumption that younger children
      are able to distinguish only two or three levels of pain intensity.

      Aim:

      The aim is to create a Czech version of pain assessment tools in children, the Simplified
      Faces Pain Scale (S-FPS) and the Simplified Concrete Ordinal Scale (S-COS), including
      methodology for their use in practice, and to establish their validity and reliability in
      pre-school children.

      The cognitive ability of the child for the research study will be verified by two control
      tasks, presented to each child prior to enrolment:

      "Describe the presented toy (a star). Choose the biggest star from these three toys (stars)
      of different sizes."

      The tools and procedure:

      Children will be asked to evaluate their pain intensity using the S-FPS and the S-COS on
      three different occasions linked to a painful procedure (before peripheral venepuncture,
      immediately after the peripheral venepuncture and 5-10 minutes after the peripheral
      venepuncture).

      Before the first venepuncture, the researcher will ask the parents what specific word their
      child uses to describe pain and then asks the child: "Do you have any pain?," (the child´s
      word used for pain). If the answer is "no", then the researcher writes "0". If he/she
      responds "yes", then the child is asked to allocate the perceived pain intensity to the
      picture, i.e. a corresponding face using the S-FPS, and a corresponding number of blocks,
      using the S-COS.

      The researcher and the attending nurse evaluate the pain at each of these time points using
      the behavioral scale Face, Legs, Activity, Cry, Consolability (FLACC) (Merkel et al., 2002).
      The child, the researcher and the attending nurse will do their assessment independently.

      Characteristics of the respondents:

      The research group will consist of a total of 180 pre-school children (with complete data on
      all items) who will be subjected to a peripheral venepuncture during their visit to a
      hospital clinic and who have not received any analgesia prior to the procedure (the
      researcher will obtain this information during the interview with the parents).

      Data Collection:

      Before collecting the data, the researcher will individually explain the whole procedure to
      all participants in such a way that they understand it well, especially to children with
      regard to their cognitive development. Furthermore, the attending nurse will undergo training
      concerning data collection and the entire study, as well.

      The researcher personally contacts the parents of the child and the child in the waiting room
      of the Children's Clinic in a tertiary hospital in the city of Olomouc and informs them of
      the research project. If they agree to being enrolled, the child will be screened for
      sufficient cognitive development and ability to distinguish three different sizes. This will
      be done using three identical toys (different sizes) that will be presented to the child and
      the researcher asks him/her to order the toys from the smallest to the largest. The correct
      arrangement of toys is the basic criterion for inclusion in the study. The child, the
      researcher and the attending nurse (the research assistant) participate in the pain
      assessment. Parents will stay with the child during the whole process, but they do not
      evaluate the pain. They will be instructed not to provide the child with any verbal or
      behavioural cues or engage in any behaviour that would either distract the child or that
      would affect the child´s performance during data collection.

      The research study is divided into 3 phases:

      Phase 1: before peripheral venepuncture: The researcher and the attending nurse complete an
      observational pain report using the FLACC. The child assesses if he/she has pain. If the
      answer is "no", the researcher writes "0", if the response is "yes", the child will evaluate
      pain using each self-report tool (S-FPS and S-COS).

      Phase 2: immediately after peripheral venepuncture: The researcher and nurse complete an
      observational pain report using the FLACC. The child assesses if he/she has pain. If the
      answer is "no", the researcher writes "0", if the response is "yes", the child will evaluate
      pain using each self-report tool (S-FPS and S-COS).

      Between phase 2 and phase 3, the child is distracted from the procedure. He/she may play with
      the parent etc.

      Phase 3: 5-10 min. after peripheral venepuncture: The researcher and nurse complete an
      observational pain report using the FLACC. The child assesses if he/she has pain. If the
      answer is "no", the researcher writes "0", if the response is "yes", the child will evaluate
      pain using each self-report tool (S-FPS and S-COS).

      Randomization:

      Each child evaluates pain using both the S-FPS and S-COS. The order in which these two tools
      are presented to the child will be random. Randomization will be done for each child three
      times, before phase 1, phase 2 and phase 3. The order is randomly assigned by a computer
      program (www.randomizer.org).
    

Intervention name(s): A painful procedure (peripheral venepuncture)
Intervention type(s): Procedure
Intervention description(s): The child will undergo a peripheral venepuncture during a scheduled visit to a hospital clinic and routinely provided care.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects indicated for peripheral venepuncture (blood draw or peripheral IV cannulation)
      
Keywords: Pain Measurement; Pain Assessment; Nurse; Nursing; Child; Pediatrics; Instrument; Scale; Tool