Development Of The Lan's Neonatal Pain Scale And Its Examination In The Clinical Situation Of Acute Procedural Pain

Long-term and repeated pain stimuli have serious adverse effects on the newborn.Therefore,strengthening the management of neonatal pain is the strategic demand of national health policy development,and it is also the inevitable trend of healthy China.Timely and accurate assessment of neonatal pain is the key to the implementation of pain management;however,neonatal pain assessment is a worldwide problem,pain assessment rate in the global neonatal ward is only 6% to 50.3%,pain assessment rate of China is 39.02%.Self-reporting is the gold standard for pain assessment,and newborns rely on pain assessment tools to assess pain because they are non-verbal.The American Academy of Pediatrics strongly recommends the use of reliable pain assessment tools to assess newborn pain,and although more than 40 neonatal pain assessment tools have been designed,the scale is not routinely used in clinical practice due to the limited scope of application,complex assessment methods,and long evaluation time.This study aims to design a neonatal pain assessment tool adapt for 4 clinical situations,including acute procedural pain,postoperative pain,mechanical ventilation pain and persistent pain,with high sensitivity and simple assessment methods to standardize neonatal pain assessment behavior,improve the execution rate of neonatal pain assessment,and ensure the quality of neonatal pain management.Objective: Aiming at the fact that there is no a neonatal pain assessment scale that can simultaneously meet the needs of common neonatal clinical pain stimulation assessment,to design a neonatal pain assessment scale suitable for 4 common clinical situations strictly compliance with the scale compilation process.The scale was used to evaluate one of the clinical situations—acute procedural pain,project analysis,pain level division,and reliability and validity tests were conducted to form an application version of the scale in the clinical situation of acute procedural pain.Methods:(1)Form the initial scale: According to the theoretical basis,framework and dimensions of the present scale,the dimensions of the scale were determined.The neonatal pain assessment scales were collected in the guidelines and the original studies through a systematic literature review,the evaluation indicators were extracted in the scales,then the evaluation indicators were supplemented through the clinical observation to form an initial item pool,which was sorted and integrated according to the dimensions of this study.The initial item pool screening was conducted by nursing experts to form the final item pool of the scale.The final item pool of the scale was integrated into a questionnaire,experts from 18 hospitals in 15 provinces and cities were invited to evaluate the contents of the final item pool of the scale through two rounds of Delphi expert consultation,finally the original version of the Lan's Neonatal Pain Scale(LNPS)was formed.(2)Form the application version of the LNPS in the clinical situation of acute procedural pain(LNPS-A): A convenience sample of 99 neonates were included from a tertiary hospital in Chongqing.Videos of acute procedural pain stimulation(heel lance,venipuncture,venous blood collection)were recorded for each neonate including three phases of procedure: 1 minute before the procedure,during the procedure,1 minute after the procedure.One rater used LNPS and Neonatal Infant Pain Scale(NIPS)to perform pain assessment by watching the recorded videos in randomly order,the assessment data were sorted out,then homogeneity test method,factor analysis method,correlation coefficient method and critical ratio method were used to screen and evaluate the items of the scale in acute procedural pain assessment.The receiver operating characteristic curve was drew to formulate the degree of pain,Kappa coefficient was used to test the degree of conformity of the pain evaluation.The reliability was evaluated by the internal consistency reliability,inter-rater reliability,and test-retest reliability.The validity was evaluated by the construct validity and criterion-related validity.The response degree evaluation was carried out by Standard Response Mean Value.Results:(1)The initial item pool consisted of 45 items,of which 7 were physiological dimension indicators,36 were behavioral dimension indicators and 2 were contextual factor indicators.After discussion by the expert group,26 items were deleted,1 item was added.The final item pool of the scale consisted of 20 items.After two rounds of Delphi expert consultation,the original version of LNPS consisted of 5 items,including “Heart rate”,“Percutaneous oxygen saturation”,“Consolability”,“Reaction to handling”,“Facial expression”.Each indicator of the scale was assigned a score of 0?1 or 2,with total score ranged from 0 to 10.In the two rounds of consultation,the positive coefficient of the experts was 51.42% and 94.44%,the degree of authority was 0.84 and 0.85,and the degree of coordination of expert opinions(Kendall's w)was 0.189 and 0.281,respectively.(2)Among the four statistical methods,meeting the criteria for deletion of two or more statistical methods is a necessary condition for the removal of items.The item of “Percutaneous oxygen saturation” reached the deletion criteria of critical ratio method,factor analysis method and homogeneity test method at the same time and was deleted.The LNPS-A finally contains four items: “Heart rate”,“Consolability”,“Reaction to handling”,“Facial expression”.Each indicator of the scale was assigned a score of 0?1 or 2,with total score ranged from 0 to 8.The results of the area under the ROC curve showed that the pain rating criteria of LNPS-A was 0-3,which was classified as no pain or mild pain,4-5 as moderate pain,and ?6 as severe pain,the Kappa of matching coefficient for the LNPS-A and NIPS was 0.687.Results of related analysis showed,the correlation coefficient between the scale items and the total score was 0.601-0.906,which administrated moderate to high correlation,and the correlation coefficient of "heart rate" and behavioural dimension was 0.409,which administrated low to moderate correlation;during and 1 minute after procedure,the correlation coefficients between LNPS-A and NIPS were 0.903 and 0.444,respectively,indicating that the validity of the scale was relatively high.The standardized Cronbach's ? for LNPS-A were 0.842 and 0.847,respectively;the inter-rater correlation coefficients of LNPS-A were 0.932 and 0.887,respectively;the test-retest reliability of LNPS-A were 0.938 and 0.895,respectively.The SRM was 1.401,indicating that the reliability of the scale was better.Conclusion:(1)The original version of LNPS is determined in this study.(2)The application version of the scale in the clinical situation of acute procedural pain is formed.LNPS-A has good reliability,validity and responsiveness,and all the indicators have reached the acceptable range of reliability and validity test.With a small number of items in the scale and a simple method of use,it can be used as a tool to evaluate the acute procedural pain in the newborn.(3)The feasibility of LNPS-A provides a theoretical basis for the application of the original LNPS in three other clinical situations: postoperative pain,mechanical ventilation pain,and persistent pain.