|Year : 2018 | Volume
| Issue : 3 | Page : 100-104
The effects of arnigol cream on pain associated with arteriovenous fistula puncture in patients receiving hemodialysis: A randomized double-blind clinical trial study
Somayeh Nejadbagheri1, Habibollahe S Hosseini2, Majid Kazemi3
1 Department of Medical Surgical Nursing, School of Nursing and Midwifery, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
2 Department of Nursing, Nursing and Midwifery School, Geriatric Care Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
3 Department of Medical Surgical Nursing, Faculty of Nursing and Midwifery, Non-Communicable Disease Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
|Date of Web Publication||29-Jun-2018|
Department of Medical Surgical Nursing, Faculty of Nursing and Midwifery, Non-Communicable Disease Research Center, Rafsanjan University of Medical Sciences, Rafsanjan
Source of Support: None, Conflict of Interest: None
Background: In each hemodialysis session, hemodialysis patients undergo two vascular punctures with large-diameter needles, which are associated with great pain. The reduction of puncture pain helps these patients accept hemodialysis and enhances their quality of life. Objective: The present study was conducted to assess the effects of Arnigol cream on the pain associated with arteriovenous fistula puncture. Methods: As a double-blind single-group randomized clinical trial, the present study was made on 71 hemodialysis patients. Each patient received an arterial and a venous fistula puncture. One puncture site was randomly allocated to the experiment and the other one to the placebo. Before needle insertion, the experiment and the placebo sites were treated for 10 min with 5 ml of Arnigol cream or Vitamin A and D ointment, respectively. After needle insertion, pain intensity at puncture sites was assessed using a visual analog scale. The data were analyzed using the paired-sample t-test. Results: Participants were 71 hemodialysis patients, 49.3% were female. The mean of participants' age was 56.86 ± 15.10 years, with a range of 22–82. The length of receiving hemodialysis ranged from 4 to 96 months with a mean of 40.36 ± 22.79. Diabetes mellitus was the major cause of renal failure among participants (56.3%). The intensity of pain at the experiment site was significantly lower than the placebo site (2.83 ± 1.60 vs. 3.46 ± 1.57; P = 0.006). Conclusions: This study showed the effectiveness of Arnigol cream in reducing the pain associated with arteriovenous fistula puncture among patients receiving hemodialysis. Thus, nurses are recommended to use this simple, safe, and inexpensive modality to reduce fistula puncture pain.
Keywords: Arnigol, Hemodialysis, Fistula, Pain management, Puncture pain
|How to cite this article:|
Nejadbagheri S, Hosseini HS, Kazemi M. The effects of arnigol cream on pain associated with arteriovenous fistula puncture in patients receiving hemodialysis: A randomized double-blind clinical trial study. Nurs Midwifery Stud 2018;7:100-4
|How to cite this URL:|
Nejadbagheri S, Hosseini HS, Kazemi M. The effects of arnigol cream on pain associated with arteriovenous fistula puncture in patients receiving hemodialysis: A randomized double-blind clinical trial study. Nurs Midwifery Stud [serial online] 2018 [cited 2018 Sep 26];7:100-4. Available from: http://www.nmsjournal.com/text.asp?2018/7/3/100/235642
| Introduction|| |
Chronic renal failure is a multifactorial physiopathologic problem which finally results in the reduction of the number and the function of nephrons. Patients with chronic renal failure need treatments such as kidney transplantation, hemodialysis, or peritoneal dialysis., The most common treatment for the disease is hemodialysis. A prerequisite to regular long-term hemodialysis is permanent vascular access, which can be established through central venous catheter, arteriovenous graft, or arteriovenous fistula. The most preferred access route is arteriovenous fistula.
Hemodialysis through arteriovenous fistula necessitates one arterial and one venous puncture using two large-diameter needles. Such punctures usually cause severe pain and discomfort for patients. Patients who receive regular hemodialysis are frequently exposed to the pain associated with around 300 vascular punctures each year. Such repetitive exposure to pain causes anxiety and depression, reduces the quality of life,, and interferes with effective role performance.
Pain is an unpleasant emotional and sensory experience due to an actual or potential tissue injury. It is among the most important nursing diagnoses, and its management is among the most important nursing responsibilities. Effective pain management improves patient satisfaction with nursing care, encourages patients to actively engage in the process of treatment, helps them readily accept hemodialysis, and enhances their quality of life. Thus, effective plans are needed to manage vascular puncture pain among hemodialysis patients.
There are different pharmacological and nonpharmacological pain management strategies including topical heat or cold therapy, rhythmic breathing, music therapy, distraction, transcutaneous electrical nerve stimulation, aromatherapy, acupressure, massage, touch,, awareness raising, active listening, and topical treatments such as Arnica topical cream, diclofenac sodium topical gel, EMLA cream, and lidocaine cream.
Arnigol is an herbal cream (produced by Goldaru Co., Isfahan, Iran), each 100 mg of which contains 5 mg of Arnica montana extract. A. montana contains sesquiterpene lactones, polyynes, flavonoids, hydroxycumarines, and caffeic acid derivatives and has analgesic, anti-inflammatory, and antiseptic effects. Thus, it is effective in managing skin wounds, particularly those with inflammation. It has been reported to have no adverse effects. Clinical studies reported that Arnica-containing gels were effective in reducing muscular pain and improving venous tone. However, it is unknown whether Arnigol cream is effective in reducing acute pain associated with arteriovenous fistula puncture.
Previous research studies introduced some pain-reducing methods. However, these methods are not routinely used by Iranian hemodialysis nurses due to their expensiveness, adverse effects, or difficulty of use. Despite the inexpensiveness and the safety of Arnigol cream, there are limited data about its effects on the pain associated with arteriovenous fistula puncture.
The present study was conducted to assess the effects of Arnigol cream on the pain associated with arteriovenous fistula puncture.
| Methods|| |
Design and participants
This was a double-blind single-group randomized clinical trial. Each patient in the study was both the experimental and the placebo case. As pain is a subjective phenomenon, considering each patient as both the experimental and the placebo case could minimize the effects of intervening factors such as gender and age. Accordingly, one fistula puncture (either arterial or venous) was randomly regarded as the experiment and the other as the placebo.
This study was done from February to May 2016, in the hemodialysis units of Ali Ibn-e- Abi Talib (PBUH) Hospital, Rafsanjan, Iran, and Shafa hospital, Kerman, Iran. Population of the study consisted of all hemodialysis patients who had an arteriovenous fistula in their hand and received hemodialysis in the study setting. Patients were included if they were receiving hemodialysis through arteriovenous fistula at least two times a week for 3 consecutive months, were fully conscious, aged 18 or more, did not suffer from neuropathies or peripheral vascular problems, had no sign of inflammation at fistula site, received no topical analgesic at fistula site before the study intervention, and had no known allergy to Arnigol cream. Exclusion criteria were unsuccessful puncture at the first attempt and participants' voluntary withdrawal from the study. Primarily, selected patients were tested for any allergy to Arnigol cream through applying 1 ml of the cream to a 5 cm surface area on their arms.
Sample size was calculated based on the results of an earlier study which reported two pain mean scores of 8.09 ± 1.92 and 10.11 ± 4.85. Accordingly, with a type I error of 0.05 and a power of 0.90, the sample size calculation formula showed that 71 patients were needed for the study [Figure 1].
Instruments and measurements
Two instruments were used to collect data. The first instrument was a demographic and hemodialysis-related questionnaire which comprised of items such as age, gender, marital and educational status, cigarette smoking, drug abuse, underlying cause of renal failure, and history of receiving hemodialysis. The second instrument was a visual analog scale (VAS) for puncture pain assessment. VAS was a 10 cm ruler on which 0 and 10 represented “no pain” and “the severest experienced pain,” respectively.
Arterial and venous punctures were performed on one hand of each patient with a 5 min interval. One site was randomly allocated to the experiment and the other to the placebo. Accordingly, for the first patient, arterial puncture was allocated to the experiment, and venous puncture was allocated to the placebo. For the second patient, this allocation was reversed. At the experiment site, 5 ml of Arnigol cream was applied 10 min before the puncture. The placebo site was similarly treated with 5 ml of Vitamin A and D mixture ointment. After 10 min of ointment application, the puncture sites were cleaned using antiseptic agents and then punctures were made. All participants were blind to the interventions, i.e., to the type of the cream used for them. The distance between the site of applying Arnigol cream and Vitamin A and D ointment was about 10 cm to prevent the effects of Arnigol cream on the placebo site. Moreover, the time interval between arterial and venous punctures was 5 min to remove the effects of the first puncture on the outcomes of the second. All punctures were performed by an experienced hemodialysis nurse, and then needles were fixated using hypoallergenic adhesive tape. Immediately after each puncture, the level of patient's puncture pain was assessed and documented by another nurse using VAS. All punctures were performed similarly using 16-gauge needles and with a needle insertion degree of 30°–45°. Beside participants, the nurse who did pain assessments was also blind to the interventions.
The data were analyzed using the SPSS software version 13 (SPSS INC., Chicago, IL, USA). The distributions of the numerical variables were assessed through the Kolmogorov–Smirnov test, and all were normally distributed. Then, pain intensity comparisons were done using the paired sample t- test at a significance level of 0.05.
The ethical approval for this study was provided by the Ethics Committee of Rafsanjan University of Medical Sciences, Rafsanjan, Iran, with the code of IR.RUMS.REC.1394.166. In addition, the study was registered in the Iranian Registry of Clinical Trials with the code of IRCT2016112615965N8. The aim and the methods of the study were described to all participants, and their written informed consents were secured. They were ensured that participation in the study was voluntary. We also adhered to the ethical principles of medical research reported in the Declaration of Helsinki.
| Results|| |
Participants were 71 hemodialysis patients [Figure 2], 35 of them (49.3%) were female. The mean of participants' age was 56.86 ± 15.10, with a range of 22–82. The length of receiving hemodialysis ranged from 4 to 96 months, with a mean of 40.36 ± 22.79. Diabetes mellitus was the major cause of renal failure [56.3%; [Table 1].
The results of the paired-sample t-test illustrated that pain intensity at the experiment site was significantly lower than the placebo site (2.83 ± 1.60 vs. 3.46 ± 1.57; P = 0.006). Comparison of pain intensity with respect to the history of diabetes mellitus indicated that Arnigol cream was more effective in reducing puncture pain among nondiabetic patients compared with diabetic ones (2.61 ± 1.35 vs. 3.48 ± 1.65; P = 0.008). Moreover, patients who had received hemodialysis for more than 48 months experienced slighter pain compared with those who had a shorter history of hemodialysis [P = 0.005; [Table 2].
|Table 2: Comparing pain intensity with respect to the cause of renal failure and the duration of receiving hemodialysis|
Click here to view
| Discussion|| |
The study was conducted on a single group of patients to remove the probable effects of intervening factors (such as age and gender). The findings indicated that the intensity of puncture pain at the Arnigol-treated puncture site was significantly lower than the site treated with Vitamin A and D ointment. Similarly, Jeffery and Belcher found that Arnica cream and tablet were more effective than a placebo in reducing pain after carpal tunnel release surgery. The similarity between our findings and the findings reported by Jeffery and Belcher may be due to the similarity of the active ingredients of Arnica and Arnigol creams, i.e., sesquiterpenes lactones. Goedemans et al. also found that both Arnica and Hirudoid creams were effective in significantly reducing bruising and pain induced by infiltration at hemodialysis cannulation site. Another study also reported that Arnica gel was as effective as ibuprofen gel in alleviating hand osteoarthritis. In addition, Iannitti et al. found that Arnica significantly reduced posttrauma and postoperative pain, ecchymosis, and edema.
Our findings also revealed that patients with a longer history of hemodialysis experienced slighter pain than those with a shorter history. In line with this finding, Verhallen et al. showed that pain perception at puncture site reduced 3 months after the initiation of hemodialysis. This finding may be due to the reduction of pain perception over time. Moreover, we found that Arnigol cream had stronger analgesic effects on nondiabetic patients compared with diabetic ones. This finding can be attributed to reduced pain perception among diabetic patients due to the peripheral neurovascular complications of diabetes mellitus.
One study limitation was the probable effects of patients' psychological conditions on their pain perception. Pain is a subjective perception, and people differ from each other respecting pain perception. Such difference might have affected the study results. We assessed pain perception only through the self-report method and hence could not verify the accuracy of pain intensity reported by participants.
| Conclusions|| |
The findings of this study suggest that Arnigol cream is effective in reducing the intensity of the pain associated with arteriovenous fistula puncture and thereby improving comfort among patients receiving hemodialysis. Thus, nurses are recommended to use this simple, safe, and inexpensive modality to reduce fistula puncture pain. Still, we recommend the future investigators to use more objective pain assessment methods to produce more conclusive evidence regarding the effects of Arnigol cream.
Hereby, we would like to thank the staffs of the dialysis units of Ali Ibn-e- Abi Tlib (PBUH) Hospital, Rafsanjan, Iran, and Shafa Hospital, Kerman, Iran, and the hemodialysis patients who participated in this study.
Financial support and sponsorship
This study was a piece of a master's thesis in nursing and supported by Rafsanjan University of Medical Sciences, Rafsanjan, Iran.
Conflicts of interest
There are no conflicts of interest.
| References|| |
Amirkhani M, Nouhi E, Jamshidi H. The comparative survey of life quality in renal transplant recipients, peritoneal dialysis, and hemodialysis patients in Kerman in the year 2013. J Fasa Univ Med Sci 2014;4:123-6.
Lacson E, Hakim RM. The 2011 ESRD Prospective Payment System: Perspectives from Fresenius Medical Care, a Large Dialysis Organization. Am J Kidney Dis: WB Saunders; 2011.
Fareed ME, El-Hay AH, El-Shikh AA. Cutaneous stimulation: Its effect on pain relieving among hemodialysis patients. J Educ Pract 2014;5:9-20.
de Queiroz Frazão CM, de Almeida Medeiros AB, E Silva FB, de Sá JD, de Carvalho Lira AL. Nursing diagnoses in chronic renal failure patients on hemodialysis. Acta Paul Enferm 2014;27:40-3.
Kumbar L. Complications of arteriovenous fistulae: Beyond venous stenosis. Adv Chronic Kidney Dis 2012;19:195-201.
MacKusick CI. End stage renal disease and renal transplantation. In: Kaplow R, Hardin SR, editors. Critical Care Nursing, Synergy for Optimal Outcomes. Massachusetts: Jane and Bartlett Publisher; 2007.
Çelik G, Özbek O, Yılmaz M, Duman I, Özbek S, Apiliogullari S, et al.
Vapocoolant spray vs. lidocaine/prilocaine cream for reducing the pain of venipuncture in hemodialysis patients: A randomized, placebo-controlled, crossover study. Int J Med Sci 2011;8:623-7.
Harris TJ, Nazir R, Khetpal P, Peterson RA, Chava P, Patel SS, et al.
Pain, sleep disturbance and survival in hemodialysis patients. Nephrol Dial Transplant 2012;27:758-65.
Quinn RR, Lamping DL, Lok CE, Meyer RA, Hiller JA, Lee J, et al.
The vascular access questionnaire: Assessing patient-reported views of vascular access. J Vasc Access 2008;9:122-8.
Zyga S, Alikari V, Sachlas A, Stathoulis J, Aroni A, Theofilou P, et al.
Management of pain and quality of life in patients with chronic kidney disease undergoing hemodialysis. Pain Manag Nurs 2015;16:712-20.
Chiang LC, Chen HJ, Huang L. Student nurses' knowledge, attitudes, and self-efficacy of children's pain management: Evaluation of an education program in Taiwan. J Pain Symptom Manage 2006;32:82-9.
Hariharan S, Ramsewak R, Chen D, Merritt-Charles L, Bridglal C. A study of the efficacy of diclofenac iontophoresis for providing effective topical analgesia. Internet J Pain Symptom Control Palliat Care 2007;5:1-10.
Sabitha PB, Khakha DC, Mahajan S, Gupta S, Agarwal M, Yadav SL, et al.
Effect of cryotherapy on arteriovenous fistula puncture-related pain in hemodialysis patients. Indian J Nephrol 2008;18:155-8.
] [Full text]
Chalaye P, Goffaux P, Lafrenaye S, Marchand S. Respiratory effects on experimental heat pain and cardiac activity. Pain Med 2009;10:1334-40.
Gélinas C, Arbour C, Michaud C, Robar L, Côté J. Patients and ICU nurses' perspectives of non-pharmacological interventions for pain management. Nurs Crit Care 2013;18:307-18.
Asgari MR, Hoshmand Motlagh N, Soleimani M, Ghorbani R. The effect of transcutaneous electrical nerve stimulation on the pain intensity during insertion of vascular needles in hemodialysis patients. Iran J Crit Care Nurs 2012;5:117-24.
Bagheri-Nesami M, Espahbodi F, Nikkhah A, Shorofi SA, Charati JY. The effects of lavender aromatherapy on pain following needle insertion into a fistula in hemodialysis patients. Complement Ther Clin Pract 2014;20:1-4.
Raddadi Y, Adib-Hajbaghery M, Ghadirzadeh Z, Kheirkhah D. Comparing the effects of acupressure at LI4 and BL32 points on intramuscular injection pain. Eur J Integr Med 2017;11:63-8.
Safari A, Behnam Vashani H, Reyhani T, Ataei Nakhei A. Effect of touch on the intensity and duration of venipuncture pain in the school-age children. Evid Based Care 2014;4:17-24.
Jeffrey SL, Belcher HJ. Use of Arnica
to relieve pain after carpal-tunnel release surgery. Altern Ther Health Med 2002;8:66-8.
Goedemans A, Liang K, Cottell B, Ockerby C, Bennett PN. Topical Arnica
and mucopolysaccharide polysulfate (Hirudoid) to decrease bruising and pain associated with haemodialysis cannulation-related infiltration: A pilot study. Ren Soc Austra J 2014;10:62.
Deshpande C, Jain V. Comparison between diclofenac transdermal patch vs. transdermal EMLA (eutectic mixture of local anaesthetic) cream for attenuation of pain of venous cannulation. J Anaesthesiol Clin Pharmacol 2010;26:231. [Full text]
Youn YJ, Kim WT, Lee JW, Ahn SG, Ahn MS, Kim JY, et al.
Eutectic mixture of local anesthesia cream can reduce both the radial pain and sympathetic response during transradial coronary angiography. Korean Circ J 2011;41:726-32.
Wichtl M. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. Medpharm Scientifice Publisher: CRC Press; 2004.
Lyss G, Schmidt TJ, Merfort I, Pahl HL. Helenalin, an anti-inflammatory sesquiterpene lactone from Arnica
, selectively inhibits transcription factor NF-kappaB. Biol Chem 1997;378:951-61.
Ross SM. Osteoarthritis: A proprietary Arnica
gel is found to be as effective as ibuprofen gel in osteoarthritis of the hands. Holist Nurs Pract 2008;22:237-9.
Iannitti T, Morales-Medina JC, Bellavite P, Rottigni V, Palmieri B. Effectiveness and safety of Arnica montana
in post-surgical setting, pain and inflammation. Am J Ther 2016;23:e184-97.
Verhallen AM, Kooistra MP, van Jaarsveld BC. Cannulating in haemodialysis: Rope-ladder or buttonhole technique? Nephrol Dial Transplant 2007;22:2601-4.
[Figure 1], [Figure 2]
[Table 1], [Table 2]