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1.1.1  Inclusion criteria

Patients were eligible to participate in this study if they aged 18
years or older, are alert to be able to express pain, agreed to give informed
consent, and receiving SC injection of 40 mg enoxaparin with the volume of 0.4
or 60 mg enoxaparin with the volume of 0.6 ml once per day.

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1.1.2  Exclusion criteria

Patient who had any of the following
criteria was ineligible to participate: (1) discharge earlier than 72hrs, had (2)
Any impairment in coagulation profiles such as thrombocytopenia, prothrombin time,
platelets count, International Normalized Ratio, (3) Liver function
disturbance, (4) Scar tissues or old hematoma at the site of injection, and
sensory alteration.

1.2     
Instruments

One questionnaire and two scales were used to collect the
data:

1.2.1     
Demographic and Medical History Data Sheet

This sheet was designed by the researchers to collect the baseline characteristics
and medical history data of the participants such as; age, gender, marital
status, education, employment status and medical diagnosis.

1.2.2     
Pain Numeric Rating Scale (PNRS)

Pain Numeric
Rating Scale (PNRS) has a single 11-point numeric scale in which respondents
select a number from 0 (no pain) to 10 (severe pain) to reflect the intensity
of their pain. The scale has high test–retest reliability in both literate and
illiterate patients (r = 0.96 & 0.95, respectively) 16. Therefore, PNRS
was used in this study to assess the pain intensity as perceived by the
participant. The participants were requested to select the number that mostly
represents their pain intensity.

1.2.3     
Hematoma Formation and Size Assessment Scale (HFSAS)

It was
found that the hematoma peak after injection was at 48hrs and the beginning of
healing at 72hrs after injection 17, thus hematoma in this study was observed
at 48hrs and 72hrs after SCAI. A transparent ruler scale was used to measure
the total hematoma size with millimeter unit 4.

1.3      Pilot Study

Once permission was granted to proceed with the
proposed study, a pilot study was conducted before starting data collection on
10 patients to assess its feasibility as well as the applicability of the
tools. Participants who shared in the pilot study were excluded from the main study
sample. The result of the pilot study confirmed that the study was feasible.

1.4      Procedure of data
collection

Once official permissions were granted from the heads
of the departments to proceed with the study, the researchers initiated data
collection. Patients meeting the inclusion criteria were approached
individually, and assigned randomly into three equal groups, control group (G1),
and study groups (G2 & G3) (35 patients for each).

This study was conducted in three phases as the following:

Assessment
phase: The researchers
interviewed the eligible participants and explained the study aim in order to
obtain their informed consent and collect the demographic and medical baseline
data. At this phase, all patients who were willing to participate in the study were
assessed for deciding the site of SCAI. The injection site was selected taking
into consideration that it should be free from any scars or hematoma before the
intervention.

Intervention
phase: At this phase, the researchers were applying
the cryotherapy through ice in plastic page for five minutes for the two study
groups (G2 immediately before injection, and G3 immediately after anticoagulant
injection). For controlling confounders that have been shown by previous
studies as factors for increasing pain sensation and hematoma formation 5-7,18,
the two study and control groups received the same injection technique. For
instance, the anticoagulant dose was slowly injected over a period of 30
seconds using a syringe ready for injection,
with insertion angle of 90 degree, with no aspiration before the injection, and
by holding the skin of the injection site between the thumb and index finger, since
these techniques can reduce pain intensity and hematoma formation 6-7. After
injection, a piece of cotton was placed on the injection site and was then
removed without rubbing. Kenko sports chronometer was used to measure the
duration of injection. A circle was done around the injection site for all
groups in order to make sure it will not be selected again for the following
injection, also to assess the occurrence and size of hematoma. Additionally,
the nurses were informed not to inject the selected arm through the study
period. Moreover, the patients were instructed not to
affect the injection site (itch, touch, & massage).

Evaluation
phase: The researchers
assessed the pain immediately after the
needle was withdrawn among the G1 and G2, while, among G3; pain was measured five
minutes after applying the cryotherapy using the PNRS. The hematoma was assessed
for the three groups after 48hrs and 72hrs by the researchers using the HFSAS.

1.5     
Ethical considerations

An official approval and permissions from the director of the
hospital and the heads of the departments were obtained. The study was conducted
in accordance with the Helsinki Declaration. All the participants gave an informed consent after they
were given full explanations about the study aim and benefits. It was
emphasized that participation in the study is voluntary. Confidentiality of patient
was assured through coding of all data. In addition, the participants were
informed that they could refuse or withdraw from the study at any time without giving
any reason.

1.6     
Data analysis

The Statistical Package for the Social Sciences (SPSS) version
20 was used for data entry, tabulation and analysis. Descriptive statistics
were computed to summarize the patients’ demographic and medical data. A
one-way between groups analysis of variance (ANOVA) was conducted to explore
the impact of the intervention on perception of pain intensity and hematoma formation.
If the output of the ANOVA
test was statistically significant, the Post hoc Tukey technique was used
to find which of the three groups was statistically different. To compare the categorical variables, Chi-square was used and to find
the difference in hematoma formed across three groups, a non-parametric ANOVA
(Kruskal-Wallis) test was
used. For a multiple regression analysis; nominal variables treated as ordinal
(education: highly educated is “higher” than illiterate, employed is “higher”
than unemployed) and age hold as ratio data. The statistical significance point
was considered at p-value

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