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175]

Original Article

A Randomized Controlled Trial to Assess the Effect of Vibratory

Stimulation on Pain Perception after Intramuscular Injection of
Benzathine Penicillin
Dainy Thomas, Ashia Qureshi1, Gautam Sharma2
Nursing Officer, Cardio Thoracic Centre, All India Institute of Medical Sciences, New Delhi, 1Dean, Galgotias University, Greater Noida, NCR, 2Department of Cardiology,
All India Institute of Medical Sciences, New Delhi, India

Abstract
Background and Objectives: Pain associated with injection is a root of great anxiety and distress and incite severe fear, which may lead
to treatment noncompliance. The present study aimed to assess the effect of vibratory stimulation on pain perception after intramuscular
(IM) injection of benzathine penicillin to patients having rheumatic heart disease (RHD). Methods: Using purposive sampling and
cross-over design, 100 RHD patients were randomly assigned to either of the 2 groups. The first group received the first IM injection with
vibration therapy, and the second injection, 21 days apart with usual standard practice, while the second group received injection in the
reverse order. Subjective and objective pain assessment was done using numerical pain rating scale and biophysiological measures [blood
pressure and pulse] respectively. Results: There was a significant decrease in subjective pain score (Mean ± SD) when vibratory stimulation
(4.52 ± 1.37, 2.91 ± 1.18 and 1.93 ± 1.09) versus usual standard practice (7.12 ± 1.2, 5.51 ± 1.5, 4.20 ± 1.4) was used (P = 0.0000) at
first, second and fifth minute respectively, while no significant change was seen on objective scores. Conclusion: Females, younger and
highly educated experienced comparatively more pain. Vibratory stimulation decreased subjective pain perception of patients receiving
IM injection of benzathine penicillin, while objective measures did not show significant results.

Keywords: Benzathine penicillin, IM injection, rheumatic heart disease, subjective and objective pain assessment, vibratory stimulation

Introduction secondary prophylaxis may be the only intervention that can

Rheumatic heart disease (RHD) has resulted in significant
cardiovascular mortality and morbidity, with about 20%–30%
of hospital admissions in India, which are the most important
sequelae of rheumatic fever (RF).[1] The epidemiology of acute
RF is linked with that of Group A beta‑hemolytic streptococcal
pharyngitis, which has a maximum incidence in the age group
of 5–15 years.[2] RHD has a prevalence of about 6/1000
population, with around one million cases in India,[3] while it
is on the decline in developed countries (<5/100,000/year).[4]
Prevention of recurrent attacks of RF is the most cost‑effective
way of preventing progressive valve damage in RHD[5] which
include reduction of exposure to Group A streptococci, primary
prophylaxis to prevent RF, and secondary prophylaxis to
prevent recurrent episodes of RF, which is the most crucial
feature of an effective RHD program. For some poor countries,
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be realistically implemented.[6‑8]
Intramuscular (IM) injection of benzathine (BZ) penicillin
every 3 weeks (every 4 weeks in low‑risk areas or low‑risk
patients) is the most effective strategy for preventing recurrent
attacks of RF.[9] The American Heart Association guidelines
have reiterated the need for patients diagnosed with rheumatic
carditis to receive long‑term antibiotic prophylaxis well into
adulthood and even for lifetime.[10] But unfortunately, it has
been associated with pain and tenderness at the site of injection.
Address for correspondence: Ms. Dainy Thomas,
Flat 104, Hira Apartment, Ward 6, Mehrauli, New Delhi ‑110 030, India.
E‑mail: dainyelby@gmail.com
This is an open access journal, and articles are distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows others to
remix, tweak, and build upon the work non‑commercially, as long as appropriate credit
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For reprints contact: reprints@medknow.com

How to cite this article: Thomas D, Qureshi A, Sharma G. A randomized

DOI: controlled trial to assess the effect of vibratory stimulation on pain perception
10.4103/jpcs.jpcs_55_18 after intramuscular injection of benzathine penicillin. J Pract Cardiovasc
Sci 2018;4:184-92.

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Thomas, et al.: Effect of vibratory stimulation on pain perception after intramuscular injection of benzathine penicillin
BZ injection is viscous in nature and therefore a painful
injection leading to anxiety, fear, and behavioral distress
among children, young adults, and their families, which further
intensifies their pain and contributes to the noncompliance
of secondary prophylaxis.[11] Pain reduction can increase the
compliance to the treatment. Health‑care staff should show
nurturing holistic care to generate trust and improve treatment
compliance.[11] Nurses are ethically and legally responsible for
managing pain and relieving suffering when possible using
effective pain management techniques.[12,13]
Research evidence shows that vibratory stimulation is an
independent nursing intervention that is advocated to minimize
pain in patients.[14,15] This study was, therefore, undertaken to
look at the effect of vibratory stimulation on pain perception
after IM injection of BZ penicillin on RHD patients.
Methods
A prospective randomized, crossover, repeated measures design
was used to enroll RHD patients between 13 and 45 years,
from the Cardiology Outpatient Department (OPD), AIIMS,
New Delhi, receiving BZ prophylaxis for ≥1 year, who did not
have any other conditions resulting in pain, were capable for
giving an adequate response to pain, and were willing to give
consent for the study. Patients having radiation injuries, peripheral
vascular disease, connective tissue disorder, muscular dystrophy,
diabetic neuropathy, any bleeding disorders, getting any type
of analgesics, any known allergy to penicillin, and generalized
edema and patients on anticoagulation therapy were excluded
from the study. There were 125 patients who were assessed for
eligibility, of whom 23 did not meet the inclusion criteria and
2 declined to participate. Hence, 100 were randomly allocated
to Group A and Group B (50 each) using a randomization table
and the 100 participants completed the study with no dropouts.
The tools used for data collection were a screening sheet
and participant data sheet for collecting demographic and
clinical data [Annexure 1], a numerical rating scale (NRS)
[Annexure 2] for subjective pain assessment, an electronic
blood pressure (BP) apparatus for measuring BP and pulse,
and a mechanical vibrator to provide vibratory stimulation.
Experts had established the content validity of the tools.
The NRS, a standardized pain scale, has a well‑established
reliability of r = 0.85 − 0.96. The BP apparatus was compared
with the standard instrument (r = 0.93). Stability of the
instrument was assessed by the test–retest method (r = 0.95).
A mechanical vibrator which delivered vibration at 50 Hz was
used to provide vibratory stimulation at the site of injection
for 5 min, before the IM injection. The working status and
safety of the vibrator were checked by the central workshop
of the institution. Permission from the Head of Department,
Cardiology and Medical Superintendent, was obtained as
per the recommendation of the Ethics Committee. Ethical
clearance for conducting the study was obtained from the
Ethics Committee, AIIMS. A pilot study was conducted
among 10 RHD patients, who met the inclusion criteria.
Journal of the Practice of Cardiovascular Sciences ¦ Volume 4 ¦ Issue 3 ¦ September-December 2018
Procedure for data collection
Patients who received BZ injection at injection room,
Cardiology OPD, CNC, AIIMS, during the period of
May–December 2012 were selected for the study. A letter
explaining the purpose of the study was given to the
participants, after which signed informed consent was taken
from the participants and from the parents of the children.
Assent was obtained from the children. Random numbers
were generated using a computer algorithm from the website
www.randomization.com. Treatment allocation was done
using sequentially numbered, opaque, and sealed envelopes.
The participants were randomly assigned to either of the two
groups: Group A and Group B. Demographic related data
were collected by interview technique using questionnaire.
According to the group, the injection was administered by the
researcher and measurements were done.
Group A (X1X0)
The baseline biophysiological measures (BP and pulse)
were obtained. Intervention was done, i.e., mechanical
stimulation using the vibrator was given by the researcher
for 5 min before administering IM injection of BZ penicillin.
Subjective pain score and biophysiological measurements were
obtained immediately after the procedure by the researcher.
Measurements were obtained at the 1st, 2nd, and 5th min,
respectively. Subsequently, the next dose of BZ penicillin
injection after 21 days was administered following the standard
procedure, i. e., without any mechanical stimulation, and pain
assessment was done as earlier.
Group B (X0X1)
A baseline biophysiological measurement was done. BZ
penicillin injection was administered following the standard
procedure, and subjective pain score and biophysiological
measurements were obtained immediately after (1st, 2nd, and
5th min) the procedure. Subsequently, the next dose of BZ
penicillin injection after 21 days was administered using the
intervention and the measurements were obtained.
Statistical analysis
Data analysis was done using STATA version 11.1, Stata
Statistical Software: StataCorp., College Station, TX:
StataCorp LP (Brazos County, Texas, US). Both descriptive
and inferential statistics were used, which included
frequencies, percentage, mean, median, range, standard
deviation, independent Student’s t‑test, and repeated
measures of ANOVA with Bonferroni correction. Chi‑square
test was used to compare the two groups. Independent
Student’s t‑test was used to compare the continuous variables
with normal distribution. Repeated measures of ANOVA with
Bonferroni correction was used to compare overall outcome
measures and for the comparison of the same according to
the demographic variables. Since repeated measures were
included in this crossover study, area under the curve was
calculated for pain, systolic BP, diastolic BP, and the pulse
of the participants, and then, they were compared for both
the groups during both the visits with ANOVA of crossover
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Thomas, et al.: Effect of vibratory stimulation on pain perception after intramuscular injection of benzathine penicillin

Table 1: Comparison between two groups according to sample characteristics (n=100)

Variable Frequency (%) P
Group A (X1X0) (n=50), n (%) Group B (X0X1) (n=50), n (%)
Age (years)
13‑20 16 (32) 14 (28) 0.395a
21‑30 18 (36) 24 (48)
31‑40 13 (26) 12 (24)
41‑45 3 (6) 0 (0)
Sex
Male 18 (36) 25 (50) 0.236a
Female 32 (64) 25 (50)
Education
≤10th standard 12 (24) 16 (32) 0.285a
11‑12 standard
th
22 (44) 25 (50)
≥graduation 16 (32) 9 (18)
Onset of RHD (years)
1‑15 41 (82) 40 (80) 0.874a
16‑30 9 (18) 10 (20)
Duration of taking benzathine penicillin (years)
≤3 20 (40) 28 (56) 0.164a
>3 30 (60) 22 (44)
a
Chi‑square test. X1: Use of vibration therapy before administration of benzathine penicillin injection, X0: Use of standard procedure for administration of
benzathine penicillin injection, RHD: Rheumatic heart disease

Table 2: Effect of usual standard practice on mean

subjective pain score among two groups and in total
participants (n=100)
Group Number of Subjective pain
participants score (mean±SD)
(n)
1 min 2 min 5 min
Group A (X1X0) 50 6.96±1.4 5.22±1.5 3.82±1.5
Group B (X0X1) 50 7.24±0.9 5.78±1.2 4.56±1.3
Total 100 7.12±1.2 5.51±1.5 4.20±1.4
Figure 1: Pain perception of the subjects at 1, 2, and 5 min, respectively,
X1: Vibration therapy, X0: Standard procedure, SD: Standard deviation
with standard practice and vibration therapy.

analysis. Statistical significance was established at the level
of P < 0.05.
Results
The sample characteristics are outlined in Table 1. The groups
were comparable with respect to age (P = 0.395), sex (P = 0.236),
education (P = 0.285), disease onset (P = 0.874), and duration
of taking penicillin prophylaxis (P = 0.164) as assessed by
Chi‑square test.
The mean subjective pain score in total participants when usual
standard practice was used was 7.12 ± 1.2, 5.51 ± 1.5, and
4.20 ± 1.4 at the 1st, 2nd, and 5th min, respectively [Table 2], while,
with vibration therapy, it was comparatively less [Table 3]. The
pain score of Group A participants was comparatively lower
than Group B participants. The pain gradually reduced over
time [Figure 1].
In total participants, with usual standard practice and with
vibration therapy, the pulse was seen increasing immediately
after the injection at the 1st min, followed by a decline to
the baseline level by the 5th min [Tables 4 and 5]. However,
the systolic and diastolic BP had shown a reduction below the
baseline level after the injection with usual standard practice,
while it maintained at the baseline level for 2 min, followed by
a slight decrease at the 5th min with vibration therapy.
The vibration therapy has a highly significant effect in reducing
the pain perception after the administration of BZ penicillin
injection (P < 0.001) [Table 6]. There is no significant effect of
the washout period between the two visits (21 days) on the pain
perception of the total participants (P = 0.83). The sequencing of
intervention has a significant effect on pain perception (P < 0.001).
There was no significant effect of vibration therapy or usual
standard practice in the pulse [Table 7] of the participants
(P = 0.27), systolic BP [Table 8] (P = 0.56), and diastolic
BP [Table 9] (P = 0.82). The washout period did not show
any significant effect on the pulse (P = 0.07), the systolic
BP (P = 0.57), and diastolic BP (P = 0.6) of the participants in

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Table 3: Effect of usual standard practice on mean objective scores (biophysiological measures [blood pressure and
pulse]) among two groups and in total participants (n=100)
Variable Group Before injection After administration of injection (mean±SD)
administration (mean±SD)
1 min 2 min 5 min
Pulse Group A (n=50) 89.92±15.3 92.44±13.7 90.74±14.3 91.36±15.0
(beats/ Group B (n=50) 93.02±16.4 94.44±20.8 88.94±17.6 91.86±18.0
minute) Total (n=100) 91.47±15.9 93.44±17.5 89.84±16.0 91.61±16.5
Systolic BP Group A (n=50) 116.8±13.7 114.82±15.5 115.5±16.0 115.38±13.0
(mmHg) Group B (n=50) 113.78±17.7 109.6±23.4 109.28±16.3 108.16±18.1
Total (n) 115.29±15.8 112.21±19.9 112.39±16.4 111.77±16.1
Diastolic BP Group A (n=50) 73.02±9.1 73.06±9.8 73.1±11.2 73.72±8.4
(mmHg) Group B (n=50) 71.68±14.2 67.18±17.0 67.00±14.8 66.88±14.3
Total (n) 72.35±11.9 70.12±14.2 70.05±13.4 70.30±12.2
Group A: X1X0, Group B: X0X1, BP: Blood pressure, SD: Standard deviation

Table 4: Effect of vibration therapy on mean subjective

pain score among groups and in total participants (n=100)
Group Number of Subjective pain score
participants (mean±SD)
(n)
1 min 2 min 5 min
Group A (X1X0) 50 4.04±1.28 2.62±1.09 1.66±0.89
Group B (X0X1) 50 5.04±1.34 3.22±1.20 2.22±1.18
Total 100 4.52±1.37 2.91±1.18 1.93±1.09
X1: Vibration therapy, X0: Standard procedure, SD: Standard deviation

both groups. Whereas sequencing of the intervention showed

a significant effect on the systolic BP (P = 0.02) and diastolic
BP (P = 0.03), it had a significant effect on the pulse (P = 0.7)
of the participants. The selected variables are compared with the
pain perception during IM injection of BZ penicillin [Table 10].
Discussion
The fear of pain during and after administration of BZ penicillin
is found to be a cause for noncompliance of RHD patients for
the secondary prophylaxis, in which the BZ penicillin has to
be taken every 21 days.[16] This randomized control trial was
undertaken to assess the effect of vibration therapy on pain
perception after administration of BZ penicillin to patients
having RHD. This study is the first one to be conducted to
assess the effect of vibration therapy [Figure 2] after IM
injection of BZ penicillin. Hence, only a few reviews were
available to compare the results.
The study group was homogeneous with regard to demographic
and clinical variables. There was no statistically significant
difference between the groups.
In the present study, the results showed that there was a
significant decrease in subjective pain score when vibration
therapy was provided before injection (P = 0.0000) as
compared to usual standard practice. The results of the present
study are supported by the gate control theory according to
which, using the body’s own nervous system, the final common
pathway for the sharp pain to the brain can be blocked by the
Figure 2: Mechanical vibrator used to give mechanical vibration before
intramuscular injection.
nerves that transmit vibratory stimuli which are given before
the injection [Figure 3].[17] The findings of the present study
were similar to the study conducted by Nanitsos et al.[18] to
investigate the effect of vibration stimuli on pain experienced
during local anesthetic injections. The results showed that both
infiltration and block injections were painful (mean anticipated
intensity: 31.25, actual: 17.82 mm on 100‑mm scale). Pain
intensity with and without vibration was 12.9 mm (range: 0–67)
and 22.2 mm (range: 0–83), respectively (P = 0.00005, paired
t‑test), and this effect was seen with both infiltration (P = 0.032)
and block anesthetic (P = 0.0001) injection subgroups.
In the present study, though there was a slight difference
in pulse rate when measured pre‑ and postprocedure with
usual standard practice and with vibration therapy, it was not
statistically found to be significant (P = 0.27). It is similar to
the study of Thomas[19] to assess the effect of cold needle on
perception of pain during administration of IM injection of
BZ penicillin to patients having RHD, in which though there
was a change in pre‑ and postprocedure pulse, there was no
statistical significance (P = 0.05).
In the present study, no statistically significant difference is found
in the pre‑ and postprocedure systolic BP when vibration therapy
was used before injection (P = 0.56). However, with usual standard
practice, the systolic BP declined to a certain extent after the

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Thomas, et al.: Effect of vibratory stimulation on pain perception after intramuscular injection of benzathine penicillin

Table 5: Effect of vibration therapy on mean objective pain scores (biophysiological measures [blood pressure and
pulse]) among groups and in total participants (n=100)
Variable Group Before administration After administration of injection (mean±SD)
of injection (mean±SD)
1 min 2 min 5 min
Pulse Group A 91.18±15.8 91.5±16.0 88.16±14.9 87.42±15.6
(beats/ Group B 89.56±16.6 96.62±16.3 94.08±17.4 92.22±16.5
minute) Total A + B 90.37±16.2 94.06±16.3 91.12±16.5 89.82±16.1
Systolic BP Group A 114.52±15.8 115.22±17.7 114.58±13.1 112.9±12.7
(mmHg) Group B 110.04±18.1 109.24±18.7 110.36±17.6 107.64±20.2
Total 112.28±17.1 112.23±18.3 112.47±15.6 110.27±16.9
Diastolic BP Group A 73.34±9.6 73.66±10.9 73.48±12.5 72.68±12.8
(mmHg) Group B 69.98±11.9 69.0±14.3 68.78±12.4 67.22±14.2
Total 71.66±10.9 71.33±12.9 71.13±12.6 69.95±13.7
Group A (X1X0): n=50, Group B (X0X1): n=50, Total: n, BP: Blood pressure, SD: Standard deviation

Table 6: Comparison of the mean pain score during two

different treatments for both the groups (n=100)
Group Area under the curve for pain (mean±SD)
With vibration With standard
therapy (X1) procedure (X0)
Group A (X1X0) 9.7±3.9 19.5±5.8
Group B (X0X1) 12.3±4.6 22.3±4.3
Diff (95% CI)=−9.9 (−8.9‑−10.9). Treatment effect: P=0.0000, P<0.001,
Period effect: P=0.83, Treatment × period (sequencing) effect: P=0.0008.
X1: Vibration therapy, X0: Standard procedure, Diff: Difference in the
means, CI: Confidence interval, SD: Standard deviation

Table 7: Comparison of the mean pulse rate during two

different treatments for both the groups (n=100)
Group Area under the curve for pulse (mean±SD)
With vibration With standard
therapy (X1) procedure (X0)
Group A (X1X0) 451.1±70.9 455.8±66.3
Group B (X0X1) 468.3±78.9 450.0±85.3
Diff (95% CI)=6.8 (−5.6‑19.2). Treatment effect: P=0.27, statistically
not significant, Period effect: P=0.07, Treatment × period effect: P=0.7.
X1: Vibration therapy, X0: Standard procedure, Diff: Difference in the
means, CI: Confidence interval, SD: Standard deviation

Table 8: Comparison of the mean systolic blood pressure

during two different treatments for both the groups (n=100)
Group Area under the curve for systolic BP (mean±SD)
With vibration With standard Figure 3: Gate control theory of pain physiology.
therapy (X1) procedure (X0)
Group A (X1X0) 544.5±70.8 544.4±71.6 since needle is a source of fear and anxiety, the previous painful
Group B (X0X1) 580.0±82.8 574.4±76.0 experiences of penicillin injection lead to a rise in preprocedure
Diff (95% CI)=2.8 (−6.8‑12.4). Treatment effect: P=0.56, statistically pulse and systolic BP, when compared to postprocedure
not significant, Period effect: P=0.57, Treatment × period effect: P=0.02. measurements.[20,21] The reduction in postprocedure systolic BP is
X1: Vibration therapy, X0: Standard procedure, Diff: Difference in the also seen in a study conducted by Kubsch et al.[22] who evaluated
means, CI: Confidence interval, SD: Standard deviation, BP: Blood
pressure
the effectiveness of a specific protocol of cutaneous stimulation in
reducing pain levels in emergency department patients.
injection. Systolic BP remained same, when vibration therapy was No statistically significant difference is found in the diastolic
given, for both the groups. These findings can be explained as, BP from baseline when vibration therapy was used before IM

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Thomas, et al.: Effect of vibratory stimulation on pain perception after intramuscular injection of benzathine penicillin

injection (P = 0.82) or with the standard practice in the present
study. These findings were supported by the study conducted
by Oyadeyi (2006)[23] to correlate resting BP and BP reactivity
to pain provoking experiences in healthy males. There was
significant positive correlation between baseline systolic BP,
systolic BP reactivity, and heart rate reactivity, while there
was no correlation of baseline diastolic BP and diastolic BP
reactivity with pain threshold and tolerance. This explains that
diastolic BP of a participant remains stable in relation to pain
sensitivity and anxiety.
In the present study, sequencing of the intervention was found to
be having significant effect on the pain perception (P = 0.0008),
Table 9: Comparison of the mean diastolic blood pressure
during two different treatments for both the groups
(n=100)
Group Area under the curve for diastolic BP (mean±SD)
With vibration With standard
therapy (X1) procedure (X0)
Group A (X1X0) 341.4±56.9 342.8±54.8
Group B (X0X1) 366.4±49.5 362.7±66.3
Diff (95% CI)=1.1 (−8.8‑11.0). Treatment effect: P=0.82, statistically
not significant; period effect; P=0.6, treatment × period effect; P=0.03.
X1: Vibration therapy, X0: Standard procedure. Diff: Difference in the
means, 95% CI: 95% Confidence interval, BP: Blood pressure
systolic BP (P = 0.02), and diastolic BP (P = 0.03). This finding
is in contrast to the finding of the study of Thomas[19] to assess
the effect of needle temperature on pain perception while
administering BZ penicillin injection. No significant effect was
seen due to sequencing of the intervention, i.e., cold needle use
and room temperature needle use in the pain perception of the
participants. They had similar mean pain scores (P > 0.05) at
both the periods. This can be explained by the psychological
aspect involved while vibration therapy was given and may be
also because of the lower pain threshold of the participants in
the group. There are no further studies to compare the findings
of the sequencing effect of vibration therapy.
The younger participants exhibited higher pain perception when
compared to older age participants. This is congruent with the
findings of the study by Chakour et al.[24] to independently assess
age‑related changes in the function of A‑delta and C‑nociceptive
fibers by examining CO2 laser‑induced thermal pain thresholds
before, during, and after a compression block of the superficial
radial nerve in 15 young and 15 healthy elderly participants.
They found higher pain perception among young participants.
They have explained this to be because elderly adults rely
predominantly on C‑fiber input when reporting pain whereas
younger adults utilize additional input from A‑delta fibers.
The females had higher pain perception as compared to males,
which is similar to the results of a study of Roger et al.,[25] to

Table 10: Correlation between the selected variables and the pain perception during intramuscular injection of benzathine
penicillin (n=100)
Variable Mean±SD
Group A Group B
With intervention With standard procedure With intervention With standard procedure
Age
13‑20 10.0±3.5 21±4.7 14.1±5.9 24.4±3.6
21‑30 10.4±5.1 20.1±6.0 12.4±3.9 20.9±4.3
31‑45 8.6±2.3 17.3±6.0 9.9±3.0 22.5±4.3
P 0.4a 0.15a 0.06a 0.05a
Sex
Male 8.8±3.3 19.1±6.1 12.6±5.8 20.2±4.6
Female 10.3±4.2 19.8±5.6 11.9±3.1 24.4±2.8
P 0.19b 0.7b 0.59b 0.0004b,*
Education
≤10th standard 8.0±3.8 17.6±5.6 10.5±3.6 21±4.2
11‑12th standard 10.2±4.0 20.7±6.4 14.0±4.95 23.3±4.1
≥graduation 10.2±3.7 19.2±4.7 10.8±3.7 21.9±4.95
P 0.24a 0.32a 0.028a,c,* 0.24a
Onset of disease (years)
1‑15 9.9±4.2 19.6±5.9 12.8±4.7 22.8±3.9
16‑30 9±2.7 19.1±5.4 10±3.6 20.3±5.7
P 0.52b 0.78b 0.09b 0.12b
Duration of taking drug (years)
≤3 10±3.1 19.4±5.96 13±4.8 22.7±4.4
>3 9.5±4.4 19.6±5.7 11.4±4.3 21.8±4.2
P 0.7b 0.89b 0.23b 0.46b
*Statistically significant, aOne‑way ANOVA, bt‑test, cBonferroni test; 2 versus 1=0.045. SD: Standard deviation

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Thomas, et al.: Effect of vibratory stimulation on pain perception after intramuscular injection of benzathine penicillin
assess the correlation between sex, gender, and pain. Results
showed greater pain sensitivity among females when compared
to males for most pain modalities.
The pain perception was higher among participants with higher
education when compared with other participants. This is similar
to the findings of Ozdemir et al. (2013),[26] who studied the impact
of two different IM methylprednisolone injection speeds on pain
intensity and pain duration among 25 patients which revealed
greater pain severity after 30‑s injections or patients who had
completed higher levels of education. The participants who were
having the disease onset before 1–15 years and who were on
prophylaxis for f3 years had higher pain perception. As the number
of years of taking prophylaxis increased, they exhibited less pain.
Conclusion
Vibration therapy is effective in decreasing pain perception
of patients during and after administration of BZ penicillin
injection. Giving vibration before injection did not produce
any significant change in biophysiological measures of the
participants when compared to usual standard practice.
Implications of the study
Nursing practice
Vibratory stimulation can be used as an adjuvant therapy for
effective pain management during IM injection. Staff nurses
in all clinical settings can be encouraged to use vibratory
stimulation for other painful procedures.
Nursing research
Nurses can conduct further research on the effect of vibratory
stimulation for other painful procedures and other painful
conditions.
Limitations of the study
This study included comparatively small sample size
and conducted in a single setting only. Blinding was not
incorporated. Objective pain assessment was limited to only
BP and pulse measurement in this study. Limited review was
available on this topic.
Future recommendations
A multicenter study with a larger sample size can be undertaken.
Studies can be done to evaluate the effectiveness of vibratory
perception in other painful injections and other painful
procedures and among pediatric group for immunizations.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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Thomas, et al.: Effect of vibratory stimulation on pain perception after intramuscular injection of benzathine penicillin

Annexures
Annexure 1:
Tool 1B: Subject Data Sheet
Code Number:............................
Date:............................
Age:............................
Sex:............................
CV/CTVS No:............................
Educational Status:............................
Onset of disease (rheumatic heart disease) in years:............................
Duration of taking drug (benzathine penicillin) in years:............................

Part 1: Pain scoring (subjective pain assessment)

Time Group A Group B
(min)
First visit with intervention Second visit without intervention First visit without intervention Second visit with intervention
1
2
5

Part 2: Biophysiological measures (objective pain assessment)

Group Biophysiological With first injection With second injection
measure
Before After injection Before After injection
injection injection
1 min 2 min 5 min 1 min 2 min 5 min
Pulse
Blood pressure

Tool 1A
A. Screening sheet
Presence of radiation injuries Yes/no
Presence of peripheral vascular disease‑ Raynaud’s disease Yes/no
Presence of any connective tissue disorder Yes/no
Patients with muscular dystrophy Yes/no
Unconscious or disoriented patients Yes/no
Patient getting any type of analgesia Yes/no
Patient with diabetic neuropathy Yes/no
Patients suffering with pain of other origin than injection Yes/no
administration
Patients on anticoagulation therapy Yes/no
Patients with any type of bleeding disorders Yes/no
Any known allergy to penicillin Yes/no
Patients with generalized edema Yes/no

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Thomas, et al.: Effect of vibratory stimulation on pain perception after intramuscular injection of benzathine penicillin

Annexure 2: Tool number 2: Numerical pain rating scale for subjective pain assessment

192 Journal of the Practice of Cardiovascular Sciences ¦ Volume 4 ¦ Issue 3 ¦ September-December 2018