Research design a blue print for conducting a study. It facilitates smooth sailing of the various research operations. The design is associated with the frame work of the study and guides planning for implementation of the study.
The present study was designed to compare the effectiveness of nebulization with and without oxygen in improving the respiratory status of children with wheezing. The study was conducted by adopting following steps of research process: research design, setting, population and sampling, instruments and tools for data collection, methods for data analysis, pilot study conducted and changes incorporated.
3.1 Experimental Design: The research design selected for this study was an experimental design. It is a quantitative research design in which the independent variable is manipulated by the researcher, subjects were randomly assigned to groups and the experiment is conducted under controlled conditions. The design was applied to explain the relationship and causality between the practice of nebulization with oxygen and without oxygen and improvement in respiratory parameters which includes respiratory rate, oxygen saturation, wheezing, retractions and dyspnoea grade.
Group I- O1 X1 O2 O3 O4 O5
Group II - O1 X2 O2 O3 O4 O5
O1 = Pre assessment of respiratory parameters
O2 to O5 = Post assessments of respiratory parameters at 5, 10, 15 and 30 minutes
X1 = Nebulization with oxygen
X2 = Nebulization without oxygen
Subjects for the study were mild to moderate wheezy children who were prescribed to be treated with combimist (salbutamol+Ipravent) nebulization. In order to avoid bias and to strengthen the results, a randomized double blind study was conducted in which the researcher and the subjects were unaware of the treatment being received. As per the computerized randomization table (prepared by the statistician) the children were allocated either to the treatment group (nebulization with oxygen) or to the control group (nebulization without oxygen) by the physician or staff nurse. Both the groups were assessed prior to the treatment and also at 5 min, 10 min, 15 min and 30 minute after the treatment to analyze the effectiveness of therapies in improving of pulmonary functions.
3.2 Setting of the Study: The study was conducted in Pediatric Out -Patient Department of G.Kuppuswamy Naidu Memorial Hospital at Coimbatore. It is a 530 bedded super specialty hospital with all the facilities. The department of Pediatrics has six consultants, junior medical officers, OPD secretary, receptionist and nursing staffs. The pediatric OPD infrastructure consisted of a reception with waiting area, play area, six consulting rooms, nebulization room, an echo room, vaccination room, treatment room, anthropometric measurement room and a room for secretary. The nursing in- charge of the OPD is a GNM qualified staff nurse who supervises 13 nursing assistants. The staff nurse assists the physician in doing procedures, administers vaccines and injections, maintains records, reports and stock and supervises the functions of the nursing assistants. Nursing assistants administer nebulization and assist physician in physical examination.
3.3 Population and Sampling: The population of the study comprised of children with mild to moderate wheezing who presented to the Pediatric Out Patient Department during the period of data collection. The total subjects
Table.3.1
Number of under five children receiving nebulization in the OPD in a calendar year (1.1.2009-31.12.2009)
Sl. no
Month
No. of children receiving nebulization
1.
January
76
2.
February
63
3.
March
44
4.
April
38
5.
May
41
6.
June
45
7.
July
43
8.
August
48
9.
September
42
10.
October
54
11.
November
68
12.
December
72
Total
634
Mean = Σx/n
= 634/12
= 52.83
Standard deviation, S=12.83
consist of 50 children with wheezing. Purposive sampling technique was adopted and the subjects who fulfilled the inclusion criteria were selected for the study. The subjects were assigned to the treatment group (Nebulization with oxygen) and to the control group (Nebulization without oxygen) as per the computer randomization chart which was already prepared by the statistician.
The total population consisted of under five children who received nebulization from the Pediatric Out Patient Department from 1st January to 31st December 2009 and it was 634.Under five children who received nebulization at the outpatient department in the month of July were about 43 cases. Nebulizations were peak in the month of January and December (Table 3.1).Sample precision method was adopted for the determination of sample size.
Sample size, n= (ZS/d) ²
Z= 1.96
S=Standard deviation
= 12.83
D=S/√n
=3.46
n =
= 46.18
~50
Under five children received nebulization from the Pediatric OPD
Sample size 46(~ 50)
Children who met inclusion criteria
Informed consent
Treatment Group Control Group
(Nebulization with Oxygen) (Nebulization without Oxygen)
n=25 n=25
3.4 Criteria for Selection of Samples:
3.4.1 Inclusion Criteria:
Children between the age group of one month to 5 years
Children with mild to moderate wheezing
Children with oxygen saturation of 92%-97%
Children who receive combimist (Salbutamol+ Ipravent) nebulization in the OPD.
Children with selected respiratory diseases
Asthma,
Hyper reactive airway disease
Bronchitis
Bronchiolitis
Wheeze associated lower respiratory tract infection.
3.4.2 Exclusion Criteria:
Children who receive supplemental oxygen therapy
Children with pneumonia and acute respiratory distress disease
Children with cardiovascular diseases
Children already prescribed with nebulization with oxygen.
3.5 Variables of the study:
3.5.1 Independent Variables: The independent variables in this study were nebulization with oxygen and nebulization without oxygen administered to the children with wheezing.
3.5.2 Dependent Variables: The dependent variables in this study were respiratory rate, oxygen saturation, retractions, wheezing and dyspnoea.
3.5.3 Extraneous Variables: The extraneous variables in this study were gender (male or female), previous respiratory disease, treatment - various medications, chronicity of the disease and immunization status.
3.6 Instruments and tools for Data Collection: The tool was prepared based on review of literature and guidance of experts from child health nursing .The tool used was Pediatric asthma severity score which was a standardized one. Tool was prepared with questions related to baseline data of the child and respiratory parameters. The study tool consists of 2 sections as follows:
Section A: This section consisted of demographic data of children including age, sex, type of family, type of cooking fuel used, family history of respiratory disease and smoking, previous history of respiratory disease, immunization status and respiratory assessment included inspection, palpation and auscultation.
Section B: Assessment of respiratory parameters include respiratory rate, oxygen saturation, wheeze score, retractions and dyspnoea grade and administration of nebulization with oxygen and nebulization without oxygen.
Scoring Key: Pediatric asthma severity score was used to assess the pulmonary function of children with wheezing before and after nebulization with oxygen and nebulization without oxygen. The selected respiratory parameters are respiratory rate, oxygen saturation, wheeze score, retractions and dyspnoea grade.
Interpretation
1. Respiratory Rate:
Age (yr)
Normal
Mild distress
Moderate distress
Severe distress
0-1 yr
30-34
35 -40
41-54
>55
1 -3yrs
25-30
31-34
35-39
>40
4-5 yrs
20-24
25-30
31-35
>36
2. Oxygen Saturation:
Grade Oxygen saturation at room air (%)
Normal : ≥97%
Mild desaturation : 95-97%
Moderate desaturation : 90-95%
Severe desaturation : < 90%
3. Wheezing score:
Grade On Auscultation
Normal - No wheezing
Mild - Terminal expiration
Moderate - Entire expiration
Severe - Inspiratory and expiratory wheeze/diminished breath sounds/both
4. Retraction score:
Grade Level
0 -No retractions
1 -Intercostal retractions
2 -Intercostal and substernal
3 -Intercostal, substernal, supraclavicular with nasal flaring
5. Dyspnoea Grade:
Grade Type
0 -No dyspnoea
1 -Occurring on unaccustomed exertion
e.g.; running, playing
2 -Occurring ordinary exertion
e.g; walking at normal pace
3 -Occurring even without ordinary exertion
4 -Occurring at rest
3.7 Technique of data collection: The data was collected in the month of July for a period of four weeks. Children with mild to moderate wheezing were selected after the explanation and consent was taken from the parents. Subjects included 50 children in which 25 children received nebulization with oxygen and the rest 25 received nebulization without oxygen as per the SPSS computer randomization schedule. The steps of the therapy were explained to the parents along with its benefits before the assessment. Children who met the inclusion criteria were selected for the interventions. The interventions were given randomly to the children as per the computer randomization chart by the staff nurse. Nebulization was given for a period of 15 minute. The steps of the interventions were as follows.
Steps of nebulization with oxygen
Dispense correct amount of medicine into the nebulizer cup.
Place the lid on top of the nebulizer cup.
Connect it to face mask or mouth piece
Connect it to oxygen - 6l/min
Provide comfortable position to the child
Place mouth piece in the mouth or place face mask securely over the face.
Turn compressor on
Continue it for 15-20 min.
Steps of nebulization without oxygen
Dispense correct amount of medicine into the nebulizer cup.
Place the lid on top of the nebulizer cup.
Connect it to face mask or mouth piece
Connect it to air compressor
Provide comfortable position to the child
Place mouth piece in the mouth or place face mask securely over the face.
Turn compressor on
Continue it for 15-20 min.
Selected respiratory parameters like respiratory rate, oxygen saturation, wheeze score, retractions and dyspnoea grade were assessed for all the children before and after the treatment by the investigator and the post assessments were done at 5 minutes, 10 minutes, 15 minutes and 30 minutes. Comparisons were made between the pre assessment and each post assessment to assess the effectiveness of the interventions.
3.8. Method of data analysis and Interpretation: The data was analyzed using descriptive and inferential statistics. Data was presented in frequency table to compare the pre and post assessment differences between experimental group and control group. Statistical analysis of 't´ test was applied to test the mean value pre and post assessments.
3.8.1 Paired't' test: The test was used to identify whether there is significant difference between pre assessment and each post assessments of both interventions.
= Mean difference between pre assessment and post assessment scores of each respiratory parameter
SD= Standard deviation between pre assessment and post assessment scores of each respiratory parameter
n = Number of subjects.
3.8.2 Independent't' test: This test was used to identify whether there is a significant difference in respiratory parameters between nebulization with oxygen group and nebulization without oxygen group. It was calculated by using the following formula.
= Mean value of each respiratory parameter in experimental group (nebulization with oxygen).
= Mean value of each respiratory parameter in control group (nebulization without oxygen)
SD=Standard deviation of each respiratory parameters in experimental group and control group.
= Number of subjects in treatment group (nebulization with oxygen)
= Number of subjects in control group (nebulization without oxygen)
3.9 Reliability and validity: The reliability of the tool was tested through pilot study. The validity was ascertained by the expert's opinion. Additions and modifications suggested by experts like history of regularity of treatment and use of specific medications were incorporated in the tool.
3.10 Report of the pilot study: Pilot study is a smaller version of a proposed study and is conducted to refine the methodology and is developed similar the proposed study. Pilot study was conducted in G.Kuppuswamy Naidu Memorial Hospital among 10 children with mild to moderate wheezing in which 5 children were assigned to each group. Pre assessment was done by the investigator before the interventions (nebulization with oxygen and nebulization without oxygen).Nebulization with oxygen and nebulization without oxygen were given by the staff nurse as per the computer randomization schedule .Post assessments were conducted at 5 minutes, 10 minutes, 15 minutes and 30 minutes by the investigator. The data was analyzed by using mean, standard deviation, paired't' test and independent 't' test. Comparisons were made between pre test and posttest respiratory parameters of each group at different time intervals and also between groups for each time intervals. Results revealed that there was a significant improvement in the pulmonary function in certain respiratory parameters like respiratory rate and oxygen saturation at 10 minutes, 15 minutes and 30 minutes in treatment group and there was no statistically significant difference in the improvement of respiratory parameters when comparing both groups.
3.11. Changes Brought after Pilot Study: The pilot study showed that the proposed study is feasible; the research design, data collection and data analysis technique were appropriate. Additional questions suggested by subject experts regarding the relationship of the child with the person having family history of respiratory disease and the relationship of the child with the person who have the habit of smoking were added after the pilot study presentation.
