Karima Elshamy & Eman Elsafety
195
lesions or fractures in foot, sprains or bruises of
the lower extremities, hemorrhage, epilepsy, dia-
betic foot complication, thrombosis, kidney stone
or gallbladder, irregular heart rate and hypotension
[26,27]
. Patients with open skin wounds on their
feet, a foot tumor or foot metastasis, or radiation
treatment to the feet was also excluded
[28]
.
Tools of the study:
Two tools were used in the study:
Tool I:
Demographic and medical interview sched-
ule:
A demographic data questionnaire was written
in Arabic language, This tool was developed by
Soliman H. (2007) in a pervious study which in-
cluded questions on gender, age, marital status,
educational background, economic factors (specif-
ically, whether patients had financial problems),
duration of hypertension, medical history and
treatments, co-morbidities, and top medical treat-
ments. It also included questions about lifestyle
modification such as fat/salty foods intake, exercise,
smoking, alcohol intake, recreation and relaxation.
This questionnaire was completed by participants
at the first day of the study
[29]
.
Tool II:
Quality of life questionnaire:
The World Health Organization Quality of Life-
BREF, Arabic version (WHOQOL-BREF) ques-
tionnaire was used. The WHOQOL-BREF is a 26-
item, self-administered, generic questionnaire that
is a short version of the WHOQOL-100 scale. The
response options range from 1 (very dissatisfied/
very poor) to 5 (very satisfied/very good). It consists
of domains and facets (or sub-domains). The items
on “overall rating of QOL” (OQOL) and subjective
satisfaction with health constitute the general facet
on OQOL and health. The more popular model for
interpreting the scores has four domains, namely,
physical health (seven items), psychological health
(six items), social relations (three items) and envi-
ronment (eight items). Participants completed this
questionnaire at the start of the study and following
four weeks of intervention
[30]
.
Methods:
Official permission to conduct the study was
taken from the hospital responsible authorities
after explaining study’s aims.
Content validity:
The content validity of the
first tool along with the including and excluding
criteria was submitted to 10 experts in the field of
medical surgical nursing, medicine and physiother-
apy for their opinion on the items in the tool and
the criteria. There was complete agreement by
experts and minimal modifications were made
based on the given suggestion.
Reliability of the tool:
A new standardized
sphygmomanometer and stethoscope were used to
check the blood pressure. The reliability of the
sphygmomanometer and stethoscope were checked
with other standardized sphygmomanometer and
stethoscope. The readings were matched with the
comparative devices used for the reliability testing.
Pilot study:
A pilot study was conducted in the
previously mentioned setting, from 5 May 2010
to 10 May 2010. The investigator obtained formal
permission from the concerned authority prior to
the study. The study was conducted on 10 hyper-
tensive patients who fulfilled the inclusion criteria
for the selection of the sample. The purpose of the
study was explained to the subjects and consents
were obtained after assuring privacy and confiden-
tiality. Baseline information was collected; and
blood pressure was checked after intervention. The
tools were found feasible and practical. No further
changes were made in the tool after the pilot study
and the investigator proceeded for the main study.
Before taking part in the study, all potential
participants were provided with information about
the study topic; the study objectives, study meth-
odology, potential risks, and treatment benefits,
privacy and confidentiality were assured. Patients
who accepted to participate were assured that their
participation was entirely voluntary and informed
of their rights as research subjects. The investigator
clarified this information verbally and provided
further details upon request. Patients who wished
to participate in the study were asked to give
consent to confirm their willingness to be involved
in the study. They were also informed that they
could withdraw from the study at any time without
any impact on their treatment.
Prior to randomization, participants were asked
to complete a demographic data questionnaire and
the World Health Organization Quality of Life-
BREF (WHO QOL BREF) questionnaire. Revision
of their laboratory data for: A blood sugar, kidney
function, lipids and gout. Electrocardiogram was
also done for all participants in the study to exclude
patients with irregular heart rate.
Eligible participants were randomly allocated
into two equal groups 40 participants in the foot
reflexology group (intervention) and 40 in the
control group (routine management). Immediately
prior to each treatment session, patients were
provided with 10-minute rest. Following this rest
time, their blood pressure level was measured by