Methodology deals with the research approach, research design, setting of the study, population, criteria for selection of sample, sample size, sampling technique, description of tool, scoring procedure, pilot study, data collection procedure, data analysis and protection of human rights.
According to Polit and Hungler, (2004) research methodology refers to the researcher ways of obtaining, organizing and analyzing data.
Research Approach
Polit and Hungler, (2004) defined the approach as “a general set of orderly discipline procedure used to acquire information”.
A quantitative evaluative approach was used to determine the effectiveness of intradialytic Stretching exercise on leg cramps among clients undergoing hemodialysis.
Research Design
Poilt and Hungler, (2004) defined research design as “overall plan for addressing a research questions, including specification for enhancing the study integrity”.
True experimental design-Post test only control group design was chosen for analyzing the
effectiveness of intradialytic stretching exercise on leg cramps.
A Post test only experimental design was used for this study.
Groups
Intervention
Number of Post test days
E
C
X
–
d1 d2 d3
d1 d2 d3
It could be represented as,
Keys:
E- Experimental group
C- Control group
X- Intervention ( Intradialytic stretching exercise)
D1- 1st day of post assessment
D2- 2nd day of post test assessment
D3- 3rd day of post test assessment
Variables
Independent variable:
In The Present study the independent variables is intradialytic strectching exercise.
Dependent variable:
In The Present study the dependent variables is level of leg cramps among clients
undergoing haemodialysis.
Demographic variable:
Age, gender , educational status, occupation, previous experience of leg cramps,
associated illness, period of dialysis.
Setting Of The Study:
Polit and Hungler, (2004) stated that the physical location and condition in which
data collection has taken place in a study is the setting of the study.
The study was conducted in Neyveli General Hospitals, at Neyveli. The hospital consist
of various departments for caring sick people. The departments like medial surgical,
pediatrics, gynecology, orthopedics, ophlalmology, dermatology, psychiatric, E.N.T,
neurology, gastrology, cardiology, urology, and dental. It is 369 bedded with separate
nephrology unit and a dialysis unit comprising beds.
Population:
Polit and Hungler, (2005) “A population is the entire aggregation of cases in
which a researcher is interested.”
Target population for the study was clients undergoing hemodialysis.
Accessible population for the study was clients undergoing hemodialysis in neyveli
general hospitals at neyveli.
Sample size:
Polit and hungler, (2005) stated that sample consists of a subset of population
selected to participate in a research study.
The sample size consisted of 60 clients undergoing dialysis in neyveli GH who
satisfied the sample selection criteria with 30 patients each in the experimental and control
group.
Criteria for selection :
Inclusion criteria:
Clients who were diagnosed as chronic kidney disease undergoing hemodialysis
minimum of 3 cycles in a week.
Able to speak either English (or) Tamil.
Exclusion criteria:
Clients who were terminally ill
Clients with musculoskeletal deformities like knee fracture, osteoarthritis,
stress fracture, bursitis, hyperkeratosis.
Clients with sensorideficit
Clients with varicose vein.
Clients with burns and ulcers in lower limbs
Clients with congenital musculoskeletal deformities .
Clients who have undergone below knee amputation.
Clients with diabetic foot.
Sampling technique:
Polit and hungler (2005) stated that the process of selecting a portion of
population is to represent the entire population.
The samples were selected for this study by adopting simple random sampling technique which means, selection of clients undergoing hemodialysis by lottery method. Samples were selected based on inclusion and exclusion criteria.
Description Of The Tool
The Modified leg cramp assessment tool was administered through structured questionnaire to assess the effectiveness of intradialytic stretching exercise on leg cramps among clients undergoing hemodialysis.
The tool consisted of two sections
Section : I
It consisted of questions regarding demographic profile of the clients undergoing hemodilysis.
It included age, gender, educational status, occupation, previous experience of leg cramps, period of dialysis treatment.
Section : II
It consisted of leg cramp assessment tool to evaluate the effectiveness of intradialytic stretching exercise for client hemodialysis.
Leg assessment tool consisted of three parts.
Part ( a )
s.no
Items
1
No leg cramps
2
Less than two times
3
Two to three times
4
More than three times Tool to assess the occurrence of number of leg cramps during hemodialysis cycle. This tool consists of four items which describe about the occurrence of leg cramps.
Part( b )
Tool to assess the average duration of leg cramp. this tool consists of four items which describe about the duration of each leg cramps.
s.no
Items
1
No leg cramps
2
Less than two minutes
3
Two to five minutes
4
More than five minutes
Part( c )
It is the modified numerical intensity scale to assess the intensity of leg
cramps. This has 0-10 readings with the maximum possible score of 3 and minimum
possible score of 0.
s.no
Scale readings
Description
1
0
No leg cramps
2
1-3
Mild leg cramps
3
4-7
Moderate leg cramps
4
8-10
Severe leg cramps
Scoring Procedures
Section : II
Part ( a )
Tool to assess the occurrence of number of leg cramps during hemodialysis cycle.this
has four items with the maximum possible score of 3 and minimum possible score of 0.
s.no
Items
scoring
1
No leg cramps
0
2
Less than two times
1
3
Two to three times
2
4
More than three times
3
Part ( b )
Tool to assess the average duration of leg cramp.this has four items with the
maximum possible score of 3 and minimum possible score of 0.
s.no
Items
scoring
1
No leg cramps
0
2
Less than two minutes
1
3
Two to five minutes
2
4
More than five minutes
3
Part ( c )
It is the modified numerical intensity scale to assess the intensity of leg cramps.
This has 0-10 readings with the maximum possible score of 3 and minimum possible score
of 0.
s.no
Scale readings
Description
scoring
1
0
No leg cramps
0
2
1-3
Mild leg cramps
1
3
4-7
Moderate leg cramps
2
4
8-10
Severe leg cramps
3
Total scoring for the three parts of leg cramp assessment tool are described as follows
Total maximum possible score for the tool is 9
Total minimum possible score for the tool is 3
So, the total score is classified as follows,
s.no
Items
scoring
1
No leg cramps
0
2
Mild leg cramps
1-3
3
Moderate leg cramps
4-6
4
Severe leg cramps
7-9
Intradialytic stretching exercise Intervention
Stretching exercise is a simple and active form of exercise. Exercise is performed on the
gastronemius and solius muscles.It will be initiated after the completion of 1 hour of dialysis for
10 minutes with an interval of half an hour for 3 times during dialysis for 3 dialysis cycle .
Validity and Reliability
Content Validity
According to Burns and Grove, (2005) “the validity of an instrument is the determination of the extent to which the instrument reflect the abstract constant that is being examined”.
Five experts in nursing and two experts in medicine evaluated the content validity of the instruments. Nursing experts were medical surgical nursing and medical experts were from nephrology department.
Reliability of the tool
Reliability of the tool was done by test – retest method. The reliability of the tool is r = 0.80. hence the tool was reliable and was used in this study.
Pilot Study
Polit and Beck, (2004) denote that “pilot study is a small-scale version or trial run done in preparation of a major study”.
The researcher conducted pilot study among six clients undergoing hemodialysis in St. Mary’s Hospital, Podanur, Coimbatore after obtaining the written permission. The purpose was to find out the feasibility of the study. It was found to be feasible.
Data Collection Procedure
A prior permission was obtained from the medical officer and nursing superintendent.the study was conducted for a period of 6 weeks.
The researcher informed about the nature and purpose of the study. A written permission was obtained from the concerned authorities of the hospital. Informed oral and written consent was obtained from the subjects. on day 1,3,5 intradialytic stretching exercise was given for 10 minutes with an interval of half an hour for three times during hemodialysis cycle and for control group routine nursing care was provided. At the end of each hemodialysis cycle post test assessment of leg cramps was done by using leg cramp assessment tool for the clients in experimental group and control group . Intervention was taught to the control group at the end of third day after the post test assessment.
Plan for Data Analysis
The demographic variables were analyzed by using descriptive statistics (frequency & percentage). The level of leg cramps was analyzed by using descriptive statistics (mean, standard deviation). The effectiveness of intradialytic stretching exercise on leg cramps was analyzed by using inferential statistics (paired’t’ test). Association between the levels of leg cramps among clients undergoing hemodialysis with their selected demographic variables was analyzed by using chi square test.
Protection of Human Rights
The study was conducted after the approval of research committee of the college. The nature and purpose of this study was explained to the health care personnel involved. Written consent was obtained from all the study participants. Anonymity and Confidentiality was maintained throughout the study. Intradialytic stretching exercises was demonstrated to the control group after the post test to overcome ethical issues.
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