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CHAPTER III
MATERIALS AND METHODS
Research methodology is the conceptual structure within which the research is
conducted. It is a blue print for collection, measurement and analysis of data. In research
methodology researcher specify which specific design was adopted and how the samples
were chosen.
Research methodology is a systematic way to solve the research problem and also
to carry out the academic study and research in a correct manner.93
The present study was conducted to evaluate the effectiveness of multi
interventional package on Quality of life of patients with chronic kidney disease
receiving hemodialysis.
This chapter describes the aspects like research approach, research design,
variables, setting, population, samples, sampling technique, criteria for sample selection,
development and description of instruments, description of intervention tool, reliability
and validity of the tools, ethical consideration, pilot study, data collection procedure and
plan for data analysis.
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3.1 RESEARCH APPROACH
The research approach is the most essential part of any research. The entire study
based on it. The research approach used in the study is an applied form of research to find
out how well the intervention is effective. In this study the effectiveness of multi
interventional package on Quality of life of patients with chronic kidney disease
receiving hemodialysis was evaluated. Therefore on quantitative evaluation research
approach was essential to test the effectiveness of the intervention for this study.
3.2 RESEARCH DESIGN
It refers to the overall plan for addressing a research question, including
specifications for enhancing the integrity of the study.93
The design used for the present study was quasi experimental - pre and post test
design with control group design to evaluate the effectiveness of multi interventional
package on quality of life among patients with chronic kidney disease receiving
hemodialysis.
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Fig 3.1 Diagrammatic presentation of the design
Purposively
selected patient
with chronic
Pre test Treatment Post Test
kidney disease
receiving
hamodialysis
Experimental O1 X O2
Group ( E ) Assess the level of Multi Assess the level of
quality of life interventional quality of life
syndrome through package starts through Kidney
Kidney Disease from first cycle of Disease Quality of
Quality of life scale hamodialysis and life scale SF-36
SF-36 (version 1.3) continued for 8 (version 1.3)
(KDQOL scale) weeks (KDQOL scale) on
(Day 1) 4th week and 8th week
of hamodialysis cycle
Control Group O1 - O2
(C) Assess the level of Assess the level of
quality of life quality of life
through Kidney through Kidney
Disease Quality of Disease Quality of
life scale SF-36 life scale SF-36
(version 1.3) (version 1.3)
(KDQOL scale) (KDQOL scale) on
(Day 1) 4th week and 8th week
of hamodialysis
cycle.
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The keys were
O1 : Pre test on patient with chronic kidney disease receiving
hamodialysis regarding quality of life in experimental group
X1 : Multi interventional package
O2 : Post test on patient with chronic kidney disease receiving
hamodialysis regarding quality of life in experimental group
O1 : Pre test on patient with chronic kidney disease receiving
hamodialysis regarding quality of life in control group
O2 : Post test on patient with chronic kidney disease receiving
hamodialysis regarding quality of life in control group.
3.3 SETTING OF THE STUDY
Research settings are specific places in a research, where data collection is to be
made. The selection of setting was done on the basis of feasibility of conducting the
study, availability of subject and permission of authorities.93
The setting chosen for the study was,
1. Gunam Multi Speciality Hospital, Hosur. It is 100 bedded hospital and has
highly equipped dialysis unit with 10 beds. An approximately 5 – 7 patients
are undergoing hemodialysis procedure per day.
2. Kavery Hospital, Hosur. It is 150 bedded hospital and has highly equipped
dialysis unit with 8 beds. An approximately 4 -6 patients are undergoing
hemodialysis procedure per day.
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6.4 VARIABLES FOR THE STUDY
Variables are characters that can have more than one value. The categories of
variables discussed in the present study was,
3.4.1 Independent Variable : Multi interventional package
3.4.2 Dependent Variable : Quality of life
3.4.3 Demographic Variables : It consists of demographic characteristics
of patients with chronic kidney disease receiving hemodialysis, i.e. Age, Sex, Marital
status, Educational status, Food pattern, Religion, Type of family, Occupation, Monthly
income, Personal ill habits, Duration of kidney disease, Duration of receiving
hemodialysis, Co morbidity profile, Leisure time activities and Support system.
3.5 POPULATION
Population is entire aggregation of subject with similar characteristics and on
whom the researcher would generalize the study findings. The population encompassed
the target and accessible population.
3.5.1 Target Population
This refers to the population, the investigator had chosen for the present study to
make generalization. The target population for the study was all the patients with Chronic
Kidney Disease receiving hemodialysis.
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3.5.2 Accessible Population:
This refers to the aggregate of subject with whom the designated criteria are
confirmed. In the present study the accessible population was patients with Chronic
Kidney Disease receiving hemodialysis, who were admitted in Gunam Multi Specility
Hospital (Experimental group) and in Kavery Hospital (Control group), who were willing
to participate and present during the period of data collection were the samples for the
study.
3.6 SAMPLE AND SAMPLE SIZE
A sample is the basic element of the population about whom the information was
collected, to represent the concept of interest. Patients with Chronic Kidney Disease
receiving hemodialysis were selected from Gunam Multi Specility Hospital
(Experimental group) and Kavery Hospital (Control group), who fulfill the inclusion
criteria were selected as the samples of the study. Total sample size was 240
(Experimental group-120 and Control group-120).
3.6.1 SAMPLE SIZE
The sample size comprised of 240 Patients with Chronic Kidney Disease
receiving hemodialysis from 2 Private Multi Speciality Hspital. The sample size was
estimated using the Power Analysis with 227 Chronic Kidney Disease, but additional 13
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subjects were included to meet the expected attrition rate 10% (227+13 = 240). The
researcher included 240 samples for the study, out of which 120 were experimental group
and 120 were control group.
By using power analysis
Sample Size = Zα2 (p x q)
d2
Zα2 = 1.96 it is table value score for 95% interval.
p = assumed or estimated proportion of clients 82% (0.82)
q = 1 – p (1 – 0.82 = 0.18)
d = Margin error, i.e. 5% (0.05)
n = (1.96)2 x 0.82 (1- 0.82)
(0.05)2
n = 227
Considering the attrition rate as 10% another 13 members included in the study.
Total sample size = 240
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Research Design
E O1 X O2
C - O1 O2
(Non randomized quasi experimental Pre and post test only with control group
design)
Target Population
(All patients with Chronic kidney disease receiving hemodialysis)
Accessible Population
All patients with Chronic kidney disease receiving hemodialysis
admitted in Gunam Multi Specility Hospital (Experimental group) and
in Kavery Hospital who are willing to participate the study
Study setting
Gunam Multi SpecilityHospital (Experimental group) and
Kavery Hospital (Control group).
Sample size = 240
Experimental group = 120 Control group = 120
Description of the instrument
*Baseline data to collect basic information about patients
*Kidney Disease Quality of life scale SF-36 (version 1.3)
(KDQOL scale) to evaluate quality of life
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Pre test
Kidney Disease Quality of life scale SF-36
(version 1.3) (KDQOL scale) to evaluate quality
of life
Control Group Experimental Group
Routine care Multi interventional package given 45
minutes during hemodilaysis cycle.
Post test 1 and 2 (after 4th and 8th weeks)
Kidney Disease Quality of life scale SF-36
(version 1.3) (KDQOL scale) to evaluate quality
of life
Analysis and interpretation
Frequency and percentage of variables
Frequency and percentage of quality of life
Effectiveness of quality of life by Independent t test
Association of variable by Chi square test
Implications and Recommendations
Fig 3.2 SCHEMATIC REPRESENTATION OF RESEARCH METHODOLOGY
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3.7 SAMPLING TECHNIQUE
Sampling is the process of selecting units for study from a population. It is a
process of selecting a subject of the population in order to obtain information regarding a
phenomenon in a way that represents the entire population.123 the purpose of using a
sampling technique is to increase representativeness and to decrease bias and sampling
error. Subjects were selected by purposive sampling method and assigned to control and
experimental groups.
3.7.1 Method of sample selection
Subjects were selected by using following procedure.
POPULATION IN DIALYSIS
UNIT IN SELECTED PRIVATE
HOSPITAL
PERMISSION OBTAINED FROM SCREENING BY SELECTION CRITERIA
HOSPITAL AND REFUSE INELIGIBLE SAMPLES
RECRUITMENT OF SAMPLE
An information sheet and consent form was
given, signed and also completed a baseline
questionnaire
PURPOSIVELY SELECTED
EXPERIMENTAL GROUP CONTROL GROUP
FINAL STUDY SAMPLE FINAL STUDY SAMPLE
N = 120
N = 120
FIGURE3.3: SAMPLING STRATEGY AND PROCEDURES TO COLLECT THE STUDY SAMPLES
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3.8 CRITERIA FOR THE SELECTION OF SAMPLE
3.8.1 Inclusion Criteria:
The samples for this study were the patients with CKD receiving hemodialysis
who were …
Male or female or transgender
Aged 18 years and above
Receiving hemodialysis 3 times per week for atleast three months
Who were willing to participate in this study
Available during the data collection period
Receiving hemodialysis as inpatient or outpatient
Having vascular access catheter placement in neck or hand
3.8.2 Exclusion Criteria:
The patients with CKD receiving hemodialysis who were….
seriously ill
suffering from any cardiac problem, malignancies, multi organ
system failure
operated within three months for major health problem
having rejection episodes.
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3.9 DATA COLLECTION INSTRUMENTS
A. DEVELOPMENT OF THE TOOL
The investigator used the following steps for préparation of the tools for the study
• Extensive review of literature
• Preparation of the blue print for the tools
• Consultation with experts from the field of study
• Preparation of the final draft of the tools
• Editing of the tools
• Review of literature
The investigator did an extensive review of related literature from books, journals,
manuals, reports of published researches, newspapers and internet to develop study
instruments.
• Preparation of blue print
The blue print included Questionnaire to collect Demographic data and Kidney Disease
Quality of life scale SF-36 (version 1.3) (KDQOL scale)
• Consultation with experts from the field of study
The tools were sent to panel of experts comprising from the fields of Medical Surgical
Nursing, Nutritionist, Physiotherapist, Psychologist, Statistician and Experts from
Nursing research department.
• Preparation of the final draft
• Editing of the final tool
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B. DESCPRITION OF TOOLS:
The tool consisted of two sections was used for the study. They are..
• Section A: Demographic variables
• Section B: Kidney Disease Quality of life scale SF-36 (version 1.3)
(KDQOL scale)
3.9.1 Section A
It consists of demographic characteristics of the patients with chronic kidney
disease receiving hemodialysis, i.e. Age, Sex, Marital status, Educational status, Food
pattern, Religion, Type of family, Occupation, Monthly income, Personal ill habits,
Duration of kdney disease, Duration of receiving hemodialysis, Co morbidity profile,
Leisure time activities and Support system.
3.9.2 Section B This consists of the Kidney Disease Quality of life scale SF-36
(version 1.3) (KDQOL scale) which is a standardized tool used to assess the level of
quality of life of the patients with Chronic Kidney Disease receiving hemodialysis both in
experimental and control group.
Scoring Procedure
The scoring procedure first transforms the raw preceded numeric values of items
to a 0 – 100 possible range with higher transformed scores always reflecting better
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quality of life. Each item is put on a 0 – 100 range, so that, the lowest and highest
possible scores are set at 0 and 100 respectively. Scores represent the percentage of total
possible score achieved. Item 17 and 22 need to be multiplied by 10 to put them on 0 –
100possible range. To recode this item, subtract 1(possible minimum) from the preceded
value, divide the difference by 6 (difference between maximum and minimum) and then
multiply by [Link] the second and final step in the scoring process, items in the same
scale are averaged together to create the scale scores. Items that are left blank (missing
data) are not taken into account when calculating the scale scores. Hence, scale scores
represent the average for all items in the scale that the respondent answered. If the answer
to the item 16 is ‘no’ the sexual function scale score should be coded as missing.
Based on the percentage of scores the levels of quality of life were graded in three
categories. They are “Poor”, “Average” and “Good”.
Scoring
Level of QOL Actual Scores Percentage of scores
Poor 1-32 <33 %
Average 33-66 33-66%
Good 67 and above >66%
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3.10 MULTI INTERVENTIONAL PACKAGE (INTERVENTION)
The researcher developed and administered the multi interventional package to
the experimental group and routine care to the control group. The individual session was
given to patients with chronic kidney disease receiving hemodialysis (one to one basis)
for a period of 8 weeks for each subject in experimental group.
3.11 CONTENT VALIDITY OF THE TOOL
Content validity is the degree to which the items in the instruments adequately
represent the content for the concept being measured.
The content validity of the demographic variables and Kidney Disease Quality of
life scale SF-36 (version 1.3) (KDQOL scale) was validated by the panel of experts
comprising from the fields of Medical Surgical Nursing, Nutritionist,Physiotherapist,
Physician, Surgeon, Physiotherapist, Psychologist,Statistician and Experts from Nursing
research department.
The content validity index score was 8.5. The experts suggestion were
incorporated in designing the final tool for the study in consultation with Guide, Co-
guide, Advisory Committee members and Statistician for its appropriateness. The tool
was modified according to suggestions and recommendation of experts. (Annexure VI)
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3.12 RELIABILITY OF THE TOOL:
Reliability is the degree of consistency with which an instrument measure what it
designed to measure.
The KDQOL scale – SF-36 (version – 1.3) was considered as standardized tool.
Internal consistency reliability estimates (Cronbach, 1951)for the KDQOL-SF TM scales
and correlations of these abbreviated scales with their corresponding KDQOL TM scales
in two split samples were confirmed that this tool was highly reliable to assess the level
of quality of life among patients with Chronic Kidney Disease receiving hemodialysis.
3.13 ETHICAL CONSIDERATION
The investigator considered and followed the ethical principle preceding the
investigation. The investigator adhered to the following actions in order to protect the
ethical rights of the patients with chronic kidney disease receiving hemodialysis.
Human Rights
1. Ethical committee approval was received from the hospital authorities.
2. Written consent was obtained from the Medical Superintendent to conduct the
study.
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3. Content validity was received from the various experts in field of Medical
Surgical Nursing, Physician, Surgeon, Nutritionist, Physiotherapist, Statistician
and Experts from the Nursing research department
Beneficence & Non-Maleficence
1. The investigator is certified to execute the Physiotherapist and Nutritionist.
2. Potential benefit and risk was explained to the subjects.
Dignity
1. Informed consent was obtained from the subjects related to the study purpose,
type of data, nature of commitments, participations and procedure.
2. Pilot study was executed to check the feasibility and time requirement of the
study.
3. Subjects’ right to withdraw / withhold the information was ensured before data
collection.
4. Investigator contact information was disseminated to all the subjects who
participated in the study.
Confidentiality
1. Confidentiality and anonymity pledge was ensured.
Justice
1. Multi interventional package was given to all the subjects irrespective of their
level of quality of life.
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3.14 PILOT STUDY
Formal consent from the concerned authority of the hospitals for experimental
group and control group was obtained. The purpose of the study and assurance was
explained to the sample. The investigator selected 12 patients with Chronic Kidney
Disease receiving hemodialysis for experimental group from Thendral Hospital, Salem
and 12 patients with Chronic Kidney Disease receiving hemodialysis for control group
from Global Medical Centre Hospital, Salem as per the inclusion and exclusion criteria.
The demographic characters and the level of Quality of life of the experimental
and control group was assessed as pretest by using the KDQOL- SF-36 (version 1.3)
scale. Multi interventional package was administered to the experimental group only.
After 4thweekand 8th week post test was conducted by using the KDQOL SF-36 (Version
1.3) scale, to assess the level of QOL. The feasibility of the study was ensured by the
pilot study. The result of the pilot study revealed that the tool was reliable and the study
was feasible. The pilot study aided the investigator to determine the method of statistical
analysis and the time requirement for data collection and intervention procedure.
3.15 METHOD OF DATA COLLECTION
The data was collected from patients with chronic kidney disease receiving
hemodialysis in experimental group and control group after obtained permission from
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Managing Director and also from the patients with chronic kidney disease receiving
hemodialysis admitted in Gunam Multi Specility Hospital (Experimental group) and
Kavery Hospital (Control group), Hosur. The data collection procedure started from
January 2016 to June 2017. The investigator selected 240 patients with chronic kidney
disease (120 patients in experimental group and 120 patients in control group) who
fulfilled the inclusive criteria were selected as a sample. The subjects were explained
regarding the purpose and usefulness of the study. The investigator assured the subjects
about the anonymity and confidentiality. Written consent was taken from each subject.
The data collection for each sample was started with introduction of the investigator after
confirming the samples. The samples were made to sit comfortably in well ventilated
place. After the brief introduction about the purpose of the study to the patients with
chronic kidney disease, demographic profile was collected. (Annexure – III)
Pretest
After obtaining the written consent from the patients with chronic kidney disease
receiving hemodialysis, pretest level of quality of life were assessed by using Kidney
Disease Quality of life scale SF-36 (version 1.3) (KDQOL scale) for 20 minutes for
experimental group and control group on Day1.
Implementation of Multi interventional package
After pretest, Multi interventional package was administered to the experimental
group and routine care was given to the control group patients with chronic kidney
disease receiving hemodialysis.
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The multi interventional package consists of
➢ Exercise championship programme with Prescription : 10 minutes with rest of 2
minutes for every 2 minutes of simple exercises like Flexion -1 Minute,
Extension- 1 Minute, Abduction- 1 Minute, Adduction- 1 Minute, Medial
rotation- 1 Minute and Lateral rotation- 1 Minute
➢ Guided imagery for Self care education and relaxation through video mode .This
takes about 15 minutes.
➢ Administration of Nutritional Supplement as Nutritional ball or adai
➢ Administration of Benson’s Relaxation therapy for 20 minutes.
Totally 45 minutes during each cycle totally 24 cycles ( 3 cycles per week) for 8 weeks.
Posttest
Post test was conducted after 4 weeks 8 weeks of intervention by using Kidney
Disease Quality of life scale SF-36 (version 1.3) (KDQOL scale) to evaluate the quality
of life among patients with chronic kidney disease receiving hemodialysis in
experimental group and control group. The detailed data collection schedule is enclosed.
(Annexure – X)
3.16 DATA ANALYSIS PROCEDURE
The data was collected from 240 patients with chronic kidney disease receiving
hemodialysis were coded and entered into Microsoft Excel Spreadsheet. The data was
analyzed by using descriptive and inferential statistics.
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Descriptive Statistics
• Frequency and percentage distribution to analyze the demographic variables.
• Mean, Standard deviation and Mean percentage was used to assess the level of
quality of life among patients with chronic kidney disease receiving hemodialysis
Inferential Statistics
• Paired t test to compare the pre and post intervention level of quality of life
among patients with chronic kidney disease receiving hemodialysis in
experimental group and control group.
• Unpaired t test to compare the post test intervention level of quality of life among
patients with chronic kidney disease receiving hemodialysis in experimental
group and control group.
• Chi-square test to associate the post test level of quality of life among patients
with chronic kidney disease receiving hemodialysis in experimental group and
control group with demographic variables.
SUMMARY
A quasi experimental design was carried on 240 patients with chronic kidney
disease receiving hemodialysis admitted in Gunam Multi Specility Hospital
(Experimental group) and Kavery Hospital (Control group), Hosur, by using purposive
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sampling technique. Kidney Disease Quality of life scale SF-36 (version 1.3) (KDQOL
scale) scale was used to assess the quality of life among patient with chronic kidney
disease receiving hemodialysis. The data was collected after obtaining the permission
from concerned personnel of the hospital authority. Analysis was planned to do by using
descriptive and inferential statistics and to be presented in the form of tables, graphs and
figures.
