Comprehensive Analysis of a Nursing Research Study

This report provides a comprehensive analysis of a nursing research study investigating pain reduction during infant immunization. The study, a randomized, placebo-controlled trial, examined the effectiveness of sucrose solutions (75% and 25%) in reducing crying time and CHEOPS scores in 16–19-month-old infants undergoing routine vaccinations. The study's background highlights the health issue of pain from needle pricks and reviews previous studies on sucrose as an analgesic. The research design, including the use of random sampling and the closed envelope technique, is critically evaluated, along with data collection methods that involved pediatricians manually counting crying time and assessing pain using the CHEOPS scale. The analysis covers the statistical methods used (ANOVA, chi-square, and binary logistic regression), the rigor of the analysis, and the significance of the results, which suggest the potential for generalizing findings to other clinical settings. The report also explores the advantages and disadvantages of the data collection methods and considers alternative approaches. The study emphasizes the importance of inclusion and exclusion criteria in defining the sample universe and highlights the study's contribution to understanding behavioral pain responses beyond crying time, offering valuable insights for nursing practice.

Bachelor of Nursing
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Background of the study :
a. What is the health issue that provides the focus of this study?
Immunization is a painful event in new-born due to needle prick. Main focus of this study is
to reduce pain during immunization in new-born.
b. Generally, what have been the results of previous studies of this issue?
Allen et al., (1996) found analgesic effect with 12 % sucrose solution, however this effect
was not statistically significant. Ramenghi et al., (1996) found that infants receiving
approximately same concentration of sucrose exhibited less crying time as compared to the
placebo group. Reis et al., (2003) didn’t find effect of oral glucose solution on the crying time
of infants.
c. What is the significance of the study?
Sucrose is well established as an analgesic. In this study, use of sucrose was being studied in
reducing pain during immunization. Moreover, main significance of this study comprises of
its application in the period beyond new-born period as this study was conducted in 16–19-
month-old infants.
Overview of the research :
a. What was the aim of the research?
The aim of our study was to determine whether using 2mL of a 75 % sucrose or a 25 %
sucrose solution decreases the infant crying time and Children’s Hospital of Eastern Ontario
Pain Scale (CHEOPS) scores after immunization with intramuscular diphtheria, tetanus, and
acellular pertussis(DTaP)/H influenza type b/inactive polio vaccination (IPV) (along with
oral polio vaccination(OPV)), pneumococcus and hepatitis A in 16–19-month old infants.
Aim could have been mentioned separately; however, it was mentioned in the introduction
part of the research article.
b. What research design was used?
In this research, randomized, placebo-controlled study design was implemented.
c. Describe the main characteristics of the research design identified.
In randomized controlled trial participants allocated to different groups at random and each
group receive its specific intervention. In placebo group, there would be intervention without
active therapeutic agent or no intervention would be provided. The people to whom
intervention is being given in randomised controlled trial (RCT) are being called as
participant or subject. In this study, infants in the age group 16 – 19 months are the subjects.
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In RCTs outcomes being measured and compared to the standard intervention and placebo;
hence RCTs are quantitative in nature. RCTs are simple and most widely accepted and
powerful tools in the clinical research. Main characteristics of the RCTs comprises of
quantitative, comparative and controlled experiments (Cook et al., 2015; Connolly et al.,
2017).
d. How did the research design chosen meet the aim(s) of the study?
Aim of this study was to evaluate effect of sucrose solutions on crying time which indicate
pain in infants. This can be assessed by performing experiment, quantifying crying time and
comparing it with placebo group. All these aspects are characteristics of RCTs. Hence, it can
be helpful in achieving aim of the study.
Sampling :
a. What were the characteristics of participants in this study?
These infants are between age group 16 – 19 months. These infants were born at term, were
of normal birth weight, were healthy, and were under routine well-child care.
b. What are the inclusion and exclusion criteria of the sample?
Inclusion and exclusion criteria not mentioned in the study.
c. Why is it important to have these criteria identified before recruitment starts?
Incorporation of inclusion and exclusion criteria can define sample universe. Decision on
sample selection can be made and patient characteristics can be identified by using inclusion
and exclusion criteria. Accurate health status of the participants can be identified using
inclusion and exclusion criteria. Variability in participant recruitment can be eliminated and
robustness of the outcome can be improved by considering inclusion and exclusion criteria.
However, in this research article, inclusion and exclusion criteria for the participants was not
mentioned (Ronconi et al., 2014).
d. What sampling technique was used in this study?
In this study, random sampling method was used. In this sampling method every participant
can get equal chance to participate in the study. Random sampling method is a type of
probability sampling in which all the members of the population have equal opportunity for
being chosen. It is a simple method of sampling which completes in a single step and each
member of the population being selected independently of another (Glennerster and
Takavarasha, 2013). In this sampling method, each participant represents representativeness
of that particular population. In this study, 537 participants were being assigned to different
groups like (1) an experimental (75 % sucrose solution), (2) an experimental (25 % sucrose
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solution), or (3) a control (sterile water solution) group according to the closed envelope
technique.
e. How was this sample appropriate for meeting the research aim?
In quantitative research, participants need to be recruited in the study because aim of the
study can be achieved by conducting experiments on these participants or exploring these
participants. Sampling specific target population can be helpful in the improving the quality
of data (Elizabeth and Jonathan, 2013).
Data collection :
a. How were the data collected?
Crying time which defines crying between needle insertion and cessation of crying was
recorded by the paediatrician. An objective scale CHEOPS was used for recording
behavioural response pain response. This scale includes six different types of pain behaviour
like cry, facial expression, verbal, torso, touch, and legs. Data related to CHEOPS was
collected in the form of written form. This written form was completed by same
paediatrician. In this scale score above 4 was considered as the pain and maximum score
observed was 13. Data collection related to crying time and pain score was blinded to
principal investigator. He was not present while providing treatment to each participant. In
this study research question was properly defined prior to initiation of the study. Hence,
accurate data was collected to meet the objective of the study. Collected data were in the
form of numbers and statistics and these were presented in the form of tables. Along with
anticipated data, un-anticipated data can be collected in the quantitative research; however, in
this study un-anticipated data was not collected (Elizabeth and Jonathan, 2013).
What specifically researcher do?
Paediatrician counted the crying time of each individual participant manually. Paediatrician
started counting crying time at the time of initiation of injection and completed the counting
at the end of caseation of crying. Since, researcher using manual method of counting, this
data can be considered as robust data and there is possibility of biasness in counting the
crying time. Data related to behavioural pain response was collected by recording pain score
in CHEOPS forms. These forms were completed by same paediatrician who collected crying
time data.
How did this data collection method fit the aims of the study :
There is robust correlation between the aim of the study and method of data collection. Aim
of this study was to collect data related to the crying time of infants during immunization. In
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this data collection also, researcher manually counted crying time in infants during
immunization. It indicates data collection fulfils aim of the study.
d. What might have been some advantages and disadvantages of this method of data
collection?
Advantages:
In this study, data was collected manually. Hence there was significant cost saving for the
data collection because there was no costlier instrument or technology was implemented for
collecting the data.
Another advantage of this type of data collection is accuracy. Manually, researcher can count
crying time by observing the patient because this type of data cannot be counted accurately
by using instruments.
Disadvantages :
More number of participants cannot be recruited in manual counting method of data
collection. If more number of participants recruited, more number of researchers required
because counting data collection by single researcher is not practically possible. Involvement
of more number of researchers can lead to variability in the data collection (Mellinger and
Hanson, 2016)
e. From your understanding of the weekly readings, what if any, are some alternative
methods of data collection that these researchers could have chosen?
Implemented method of data collection was appropriate for this study.
Data analysis and results:
How were data analysed?
SPSS 16.0 for Windows (Chicago, IL, USA) was employed for the statistical analysis. Two
types of statistical tests like analysis of variance (ANOVA) test and chi-square test. ANOVA
was used to find out the difference between means of more than two groups and chi-square
test was used for comparison of rates of more than two groups. Binary logistics regression
was employed in the statistical analysis for determining independent factors influencing
dependent two-categorical variables. p<0.05 was considered as statistical significance.
Forward-likelihood ratio method was for regression analysis. In this method, entry testing is
based on the significance of the score statistic and removal testing is based on probability of a
likelihood-ratio statistic (Faltin et al., 2012).
b. Was the data analysis method appropriate for the study question and the research
design?
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ANOVA method used for statistical analysis is appropriate method because it is most widely
used method for the finding out variation among and between groups. ANOVA is applicable
to wide range of practical problems. In this study, mean difference between the different
groups like 75 % sucrose solution, 25 % sucrose solution and sterile water solution group
need to be identified. In chi-square test, probability of observations would be made with
respect to null hypothesis. In this test, significant difference in the rate between two different
groups can be identified. In this study, using chi-square test, difference in rate of crying
between 75 % sucrose solution and 25 % sucrose solution was identified. In this study, pain
score 4 was considered as the dependent variable. This dependent variable can be changed by
independent variable. Hence, binary logistic regression was used for evaluating influence of
independent variable on dependent variable (Faltin et al., 2012).
c. What did the researchers say about the rigour of their analysis?
In quantitative research rigour is based on validity and reliability. Researchers mentioned that
analgesic activity of sucrose is mainly due to its concentrated form which is evident in other
studies also. It indicates these results are valid and reliable (Roth, 2015).
d. How did the researchers describe the significance of the results?
In most of the studies, only crying time was measured; however, CHEOPS pain scores were
not determined. Hence, it can be helpful in identifying other behavioural pain-response
dimensions. In most of the previous studies, analgesic effect of sucrose was studied on new-
born; however, this study gave data related to analgesic effect of sucrose on infant of 16 – 19
months old.
e. Into which other settings can these results be generalised?
These results can be implemented in other ambulatory practice sites and hospital settings in
the same age group participants.
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References:
Allen, K.D., White, D.D., and Walburn, J.N. (1996). Sucrose as an analgesic agent for infants during
immunization injections. Archives of Pediatrics & Adolescent Medicine, 150(3), 270–274.
Cook, J.A., Hislop, J., Altman, D.G., et al. (2015). Specifying the target difference in the primary
outcome for a randomised controlled trial: guidance for researchers. Trials, 16:12. doi:
10.1186/s13063-014-0526-8.
Connolly, P., Andy, B., Miller, S., et al. (2017). Using Randomised Controlled Trials in Education.
SAGE.
Elizabeth, C., and Jonathan, D. (2013). Quantitative Health Research: Issues And Methods: Issues
and Methods. McGraw-Hill Education (UK).
Faltin, F., Ron, S. K., and Fabrizio, R. (2012). Statistical Methods in Healthcare. John Wiley & Sons.
Glennerster, R., and Kudzai, T. (2013). Running Randomized Evaluations: A Practical Guide.
Princeton University Press.
Mellinger, C. D., and Hanson, T. A. (2016). Quantitative Research Methods in Translation and
Interpreting Studies. Routledge.
Ramenghi, L.A., Wood, C.M., Grifith, G.C., and Lvene, M.I. (1996). Reduction of pain response in
premature infants using intraoral sucrose. Archives of Disease in Childhood. Fetal and
Neonatal Edition, 74, 126–128.
Ronconi, J.M., Shiner, B., and Watts, B.V. (2014). Inclusion and exclusion criteria in randomized
controlled trials of psychotherapy for PTSD. Journal of Psychiatric Practice, 20(1), 25-37.
Roth, W. M. (2015). Rigorous Data Analysis: Beyond “Anything Goes”. Springer.
Reis, E.C., Roth, E.K., Syphan, J.L., Tarbell, S.E., and Holubkov, R. (2003). Effective pain reduction
for multiple immunization injections in young infants. Archives of Pediatrics & Adolescent
Medicine, 157(11), 1115–1120.
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