401208 Research For Nursing And Assessment Answers

• What is the health issue that provides the focus of this study?
• Generally, what have been the results of previous studies of this issue?
• What is the significance of the study?

• What was the aim of the research?
• What research design was used?
• Describe the main characteristics of the research design identified.
• How did the research design chosen meet the aim(s) of the study?

Sampling

The health issues discussed here is the need to reduce the procedural pain during the immunization or vaccinations with intramuscular diphtheria, tetanus, and acellular pertussis (DtaP)/Haemophilus influenza type b/IPV (alongside oral polio vaccination, OPV), intramuscular pneumococcus as well as intramuscular hepatitis A

Generally, what have been the results of previous studies of this issue?

The previous studies have well-established the analgesic effect of sucrose on newborns but have little knowledge regarding whether sucrose solution can effectively reduce procedural pain in infants past the newborn era.

What is the significance of the study?

This study is significance because it adds into the literature by solving the gap on the effectiveness of sucrose solution in the reduction of procedural pain in infants beyond the era of the newborn. Thus, by confirming the effectiveness of sucrose in pain reduction and distress among the infant it will to provide safe and clinically safe immunization even for 16-19-month-old infants. Thus it has clinical implication because sucrose remains inexpensive and easy to administer intervention even by non-healthcare professionals and hence can always effectively help during the vaccinations/immunizations. This, research also gives a significance indication that sucrose can be used in the prevention of pain during other procedures in ambulatory practices contexts as well as in hospitals, in this cohort.

Overview of the research design

What was the aim of the research?

The aim of the study was to determine effects of sucrose solutions administered orally on infant crying times and also to measure the distress in a 16 to 19-month old cohort. This would help know whether these solutions stood effective in procedural pain reductions in infants past the newborn era.

What research design was used?

A randomized placebo- controlled trial design was explored in this study.

Describe the main characteristics of the research design identified

In this trial, some of the subjects are given treatment, others fake treatment (placebo) and neither the subjects or researchers know which is which till they end of the study and hence remain blinded. The research design was quantitative in nature (crying time and measure distress based on scale). It involved randomization of the subjects in either of the three groups based on closed enveloped. The groups contained experimental (75% sucrose solution), experimental (25% sucrose solution) and control (sterile). Data collection was primary one. Data analysis was statistical-based using SPSS, ANOVA and chi-square test, and binary regressions.

How did the research design chosen meet the aim(s) of the study?

The aim of the study was met via the chosen design because it enabled the effective data collection and analysis of the right and large sample of infants which was then statistically analysed, discussed and interpreted to help confirm the effectiveness of solution in pain reduction in infants beyond newborn era during immunization.

Sampling

What were the characteristics of participants in this study?

The participants of the study were infants and children who were receiving their regular vaccinations. They were aged between sixteen and nineteen months and they were attending the well-child unit of Department of Paediatrics. The infants were born at term, and were of normal both weight, and hence healthy and only required routine well-child care. 

What are the inclusion and exclusion criteria of the sample?

The infants had to be born at term, and were of normal both weight, and hence healthy and only required routine well-child care. They were to be between 16 and 19 old months old infants. They were only to be healthy and attend their regular well-child unit department of paediatric. They had to be those who were receiving their regular vaccinations.

Why is it important to have these criteria identified before recruitment starts?

It was extremely important to have the criteria identified before recruitment because it would either assist the parents to agree or not to agree on whether their infants would be used in the experiment. Also, it was important because the intervention could only succeed when the right sample was recruited.

What sampling technique was used in this study?

The randomized sampling technique was employed in this study. 16 to 19-month-old infants were randomly assigned to 1 of 3 cohorts. These included 1 (an experimental, 75% sucrose solution); 2 (an experimental, 25% sucrose solution) or 3 (a control, sterile water solution) cohort in accordance with closed envelop technique.

How was this sample appropriate for meeting the research aim?

The sample was large enough to help meet the research aim. Moreover, the characteristics of the subjects (sixteen to nineteen-month-old) infants were suitable as this would help meet the intended primary outcome, “crying time” when the intervention was done in the experimental groups. 

Data collection

How were the data collected?

A total of 694 healthy infants and kids receiving their regular immunization aged between sixteen and nineteen months who attended the well-child unit of Department of Paediatrics were recruited and randomized for this study between 2013 June and 2014 June. 537, overall, infants were analysed. Data was collected as the experiments and procedures were being done as discussed in subsequent sub-section below.

What specifically did the researchers do?

Researchers got permission to carry out the study from Dr. Sami Ulus Children and Maternity Training Hospital’s ethics committee. The researchers approached the families through research assistants that explained the probe’s nature and acquired informed consent. The researcher subsequently assigned 16-19-month-old infants at random to one of the 3 treatments groups in accordance with closed envelope technique. The researchers had prepared water and sucrose solutions before the study by use of a pharmacists. They researchers drew solutions from coded bottles and administered through a syringe. The researcher blinded the nurses and parents to solution used nature in the entire study. The researchers placed the solutions in coded oral syringes using pharmacist to guarantee parents, nurses and probers stood blind to cohort assignment. The control and experimental cohorts were given orally 2 mL of either sterile water or 25 percent sucrose solution or 75 percent sucrose solution before injections. The researchers recorded gender and age of the infant. Partaking mothers were queried about their educational and socioeconomic levels and researchers classified them as either “no schooling, illiterate,” “primary education,” “secondary education”, or “university education”. The socioeconomic levels were classified based on income per month per household. The researchers also assessed in past painful experience by querying the mothers. Researchers seated the mothers with children in their arms and single nurse provider utilized soothing techniques. They noted the use of an infant pacifier/pre-treatment with paracetamol. Researchers ensured that all infants stood awake during the procedure. The nurse administered all test orally over a period of up to 15 seconds. The nurse then orally gave OPV. DtaP, DPT+Hib+IPV, intramuscular pneumococcus, alongside intramuscular hepatitis A were also administered in deltoid region of left and right arm simultaneously. The nurse administered pneumococcus vaccination for infant who were vaccinated at 1 year of age. All infants received either three or two injections. The whole procedure was videotaped. The researchers defined the primary outcome (crying time) as crying from the point of insertion of need till all activity stopped and recorded by paediatrician. The researchers used CHEOPS to assess the acute behavioral pain response as an objective scale (9, 23, 35). Pain behavior was categorized into six including “cry, facial expression, verbal, torso, touch, and legs”. Researchers complemented the CHEOPS forms using same paediatrician. Scores beyond 4 denoted pain, with the maximum pain being 13. The researchers blinded principal investigator was recording crying time and pain score and ensured he was absent during intervention.

How did this data collection method fit the aims of the study?

The data collection fit the aims because of using the right scale to score the pain. Also, blinding the principle investigator and ensuring his absence during investigation ensured validity and prevented any bias. RCT ensured reduced selection bias hence results are valid and credible.

What might have been some advantages and disadvantages of this method of data collection?

The advantage is that it is videotaped and hence no biasness or alterations of data. The disadvantage is that only one nurse was involved in all administration and hence this might be prone to error made at one point by single person affecting the entire process. 

From your understanding of the weekly readings, what if any, are some alternative methods of data collection that these researchers could have chosen?

Data could as well be collected through manual means or they could have been drawn from the secondary studies or documentation in the hospital.

Data Analysis and results

How were the data analysed?

The data were statistically analysed in this study using the SPSS 16.0 version for the Windows (Chicago, II, USA). The ANOVA test was utilized in the investigation of the variations between means of more than 2 cohorts. The chi-square test was used in comparing the rates between 2 or more cohorts. The binary logistic regressions were employed in determining independent variables that influenced the dependent 2-categorula variables with the statistical significance being set at p<0.05.

Was the data analysis method appropriate for the study question and the research design?

The data analysis was appropriate in this study. This is because the investigators used a primary quantitative method and hence quantitative methods of analysis including SPSS, ANOVA, chi-square tests and Binary logistic regressions sufficed. This can be attested by the effective results that the analysis generated. For example, the authors were able to use these test to determine whether there were statistical differences between the groups in respect of age, weight, sex, past painful experience, vaccination time, of injection number, paracetamol administration and pacifier.

What did the researchers say about the rigour of their analysis?

The analysis of this study is believe to be highly vigorous and enabled the researchers to meet their intended goals. For examples, the researchers have managed to shown that past pain experience was significant independent variable for higher CHEOPS pain scores.

How did the researchers describe the significance of the results?

The significance of the results was described on the basis of the p-value or statistical significance.

Into which other settings can these results be generalised?

These results can also be generalized in other ambulatory practice sites and hospitals content to prevent pain during these procedures for the infants between sixteen and nineteen-month-old.