|Year : 2018 | Volume
| Issue : 3 | Page : 184-192
A randomized controlled trial to assess the effect of vibratory stimulation on pain perception after intramuscular injection of benzathine penicillin
Dainy Thomas1, Ashia Qureshi2, Gautam Sharma3
1 Nursing Officer, Cardio Thoracic Centre, All India Institute of Medical Sciences, New Delhi, India
2 Dean, Galgotias University, Greater Noida, NCR, India
3 Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India
|Date of Web Publication||11-Jan-2019|
Ms. Dainy Thomas
Flat 104, Hira Apartment, Ward 6, Mehrauli, New Delhi -110 030, India
Source of Support: None, Conflict of Interest: None
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
|How to cite this article:|
Thomas D, Qureshi A, Sharma G. A randomized controlled trial to assess the effect of vibratory stimulation on pain perception after intramuscular injection of benzathine penicillin. J Pract Cardiovasc Sci 2018;4:184-92
|How to cite this URL:|
Thomas D, Qureshi A, Sharma G. A randomized controlled trial to assess the effect of vibratory stimulation on pain perception after intramuscular injection of benzathine penicillin. J Pract Cardiovasc Sci [serial online] 2018 [cited 2019 May 19];4:184-92. Available from: http://www.j-pcs.org/text.asp?2018/4/3/184/249937
| Introduction|| |
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). 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. RHD has a prevalence of about 6/1000 population, with around one million cases in India, while it is on the decline in developed countries (<5/100,000/year). Prevention of recurrent attacks of RF is the most cost-effective way of preventing progressive valve damage in RHD 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, secondary prophylaxis may be the only intervention that can be realistically implemented.,,
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. 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. But unfortunately, it has been associated with pain and tenderness at the site of injection.
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. Pain reduction can increase the compliance to the treatment. Health-care staff should show nurturing holistic care to generate trust and improve treatment compliance. Nurses are ethically and legally responsible for managing pain and relieving suffering when possible using effective pain management techniques.,
Research evidence shows that vibratory stimulation is an independent nursing intervention that is advocated to minimize pain in patients., 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.
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.
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 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.
|Table 1: Comparison between two groups according to sample characteristics (n = 100)|
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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].
|Table 2: Effect of usual standard practice on mean subjective pain score among two groups and in total participants n = 100)|
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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)|
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|Figure 1: Pain perception of the subjects at 1, 2, and 5 min, respectively, with standard practice and vibration therapy.|
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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 [Table 4] and [Table 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.
|Table 4: Effect of vibration therapy on mean subjective pain score among groups and in total participants (n = 100)|
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|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)|
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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).
|Table 6: Comparison of the mean pain score during two different treatments for both the groups (n = 100)|
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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 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].
|Table 7: Comparison of the mean pulse rate during two different treatments for both the groups (n = 100)|
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|Table 8: Comparison of the mean systolic blood pressure during two different treatments for both the groups (n = 100)|
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|Table 9: Comparison of the mean diastolic blood pressure during two different treatments for both the groups (n = 100)|
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|Table 10: Correlation between the selected variables and the pain perception during intramuscular injection of benzathine penicillin (n = 100)|
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| 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. 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 thefirst 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.
|Figure 2: Mechanical vibrator used to give mechanical vibration before intramuscular injection.|
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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 nerves that transmit vibratory stimuli which are given before the injection [Figure 3]. The findings of the present study were similar to the study conducted by Nanitsos et al. 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 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 injection. Systolic BP remained same, when vibration therapy was given, for both the groups. These findings can be explained as, since needle is a source of fear and anxiety, the previous painful experiences of penicillin injection lead to a rise in preprocedure pulse and systolic BP, when compared to postprocedure measurements., The reduction in postprocedure systolic BP is also seen in a study conducted by Kubsch et al. who evaluated the effectiveness of a specific protocol of cutaneous stimulation in reducing pain levels in emergency department patients.
No statistically significant difference is found in the diastolic BP from baseline when vibration therapy was used before IM injection (P = 0.82) or with the standard practice in the present study. These findings were supported by the study conducted by Oyadeyi (2006) 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), systolic BP (P = 0.02), and diastolic BP (P = 0.03). This finding is in contrast to the finding of the study of Thomas 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. 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., to 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), 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
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.
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.
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
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10]