Reliability and Validity of the Face, Legs, Activity, Cry, Consolability Behavioral Scale in Assessment of Acute Pain in Healthy Newborn Infants

The Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale was originally developed and evaluated for post-operative pain assessment in children between two months and seven years of age. Multiple pain assessment scales have been validated for use under a variety of clinical situations for different pediatric age groups. However, nursing care and electronic documentation could be simplified if a single pain assessment scale could be used on pediatric units and the newborn nursery. However, there is limited evidence of reliability and validity for use in healthy newborn infants. The purpose of the study was to evaluate the reliability and validity of the FLACC Behavioral Scale when used in clinical care of healthy newborn infants during the first few days of life.

Four observers were trained to achieve acceptable intra-rater and inter-rater reliability on the FLACC Behavioral Scale and the Neonatal Facial Coding System (NFCS) which is another behavioral pain scale. Direct observations were performed before, during, and after routine heel puncture in 47 healthy newborn infants (370 FLACC Behavioral Scale scores). Audiotaped crying behavior was coded by the researcher who was masked to FLACC and NFCS scores. Inter-rater reliability will be determined with intra-class correlation coefficients, and internal consistency will be determined with KR20 form of Cronbach’s alpha. No test-retest or intra-rater reliability will be calculated due to the direct observation aspect of the research study, however this corresponds with clinical use of pain assessments. Construct validity will be determined by comparison of scores before, during, and after heel puncture, with the expectation that scores will be highest during heel puncture. In addition, construct validity will be determined with correlation between FLACC and NFCS scores at each observation and the correlation between percent crying and mean FLACC score during the entire heel puncture. The range of scores reported during acute pain (heel puncture) will be evaluated to determine whether the FLACC Behavioral Scale has ceiling or floor effects that would limit utility in measuring pain.

The results of this study will provide evidence of reliability and validity of the FLACC Behavioral Scale for acute pain assessment in healthy newborn infants. Nurses can use this evidence when making decisions about a choice of acute pain assessment tool to use in clinical practice and research.