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| Year : 2018 | Volume
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| Issue : 2 | Page : 369-375 |
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| Evaluation and comparison of the effects of Xyla-P cream and cold compress on the pain caused by the cannulation of arteriovenous fistula in hemodialysis patients |
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Ziba Ghoreyshi1, Monireh Amerian2, Farzaneh Amanpour3, Hossein Ebrahimi4
1 Student Research Committee, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran
2 Imam Hossein Center for Education, Research and Treatment, Shahroud University of Medical Sciences, Shahroud, Iran
3 Department of Epidemiology and Biostatistics, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran
4 Randomized Controlled Trial Research Center, Shahroud University of Medical Sciences, Shahroud, Iran
Click here for correspondence address and email
| Date of Web Publication | 10-Apr-2018 |
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 Abstract | | |
This study aimed to investigate and compare the effects of Xyla-P cream and cold compress on the pain caused by the insertion of a needle into the arteriovenous fistula (AVF) in hemodialysis (HD) patients. This clinical trial was conducted on HD patients who were selected using simple random sampling method. Using a visual analog scale, pain intensity was measured during two HD sessions in three stages including after the application of a placebo, after application of Xyla-P cream, and after the application of cold compress. The collected data were analyzed using descriptive statistics and repeated measures analysis of variance. Our results showed that there were statistically significant differences between the pain scores of the control group and Xyla-P cream group (P <0.001) and cold compress group (P <0.001) and between the pain scores of the Xyla-P cream group and cold compress group (P <0.001). The cannulation of an AVF causes moderate pain in HD patients. Cold compress is more effective than Xyla-P cream in reducing the intensity of the pain. Therefore, the nurses are recommended to use this pain relief method instead of medicinal methods.
How to cite this article:
Ghoreyshi Z, Amerian M, Amanpour F, Ebrahimi H. Evaluation and comparison of the effects of Xyla-P cream and cold compress on the pain caused by the cannulation of arteriovenous fistula in hemodialysis patients. Saudi J Kidney Dis Transpl 2018;29:369-75 |
How to cite this URL:
Ghoreyshi Z, Amerian M, Amanpour F, Ebrahimi H. Evaluation and comparison of the effects of Xyla-P cream and cold compress on the pain caused by the cannulation of arteriovenous fistula in hemodialysis patients. Saudi J Kidney Dis Transpl [serial online] 2018 [cited 2022 May 25];29:369-75. Available from: https://www.sjkdt.org/text.asp?2018/29/2/369/229265 |
| Introduction | |  |
Kidney failure is considered as one of the major public health problems in the world,[1] which is associated with high rates of morbidity and mortality.[2] As reported in 2011, the prevalence of the disease was 1040 cases per million population in the United States and 1970 cases per million population in 27 European countries.[3] According to statistics, the population of dialysis patients in the United States doubles every 10 years.[4],[5] The incidence rate of kidney failure in Iran is high, which is about 22.6%/year.[6] It is estimated that the number of hemodialysis (HD) patients in the world will have reached 3.5 million people by 2020.[7] Available statistical data on HD patients in Iran suggest that the incidence of kidney failure in Iran is higher than the average global incidence rate and it increases by about 15% annually.[3]
Hemodialysis is the most common form of renal replacement therapy in Iran and world-wide;[8] it prolongs the survival time, reduces comorbidity, and improves the quality of life.[9] Chronic HD requires a permanent vascular access which can be used for months or years. Arteriovenous fistula (AVF) is the ideal permanent vascular access.[10] Overall, about 80% of HD patients in Europe, 24% in the United States,[11] and 90% in Iran undergo HD using AVF.[12] Despite the benefits of AVF, as compared with other methods of access to vessels, the pain caused by the insertion of a needle into the AVF is considered to be a common and unavoidable complication of this method.[13] The cannulation of vascular catheters is the most stressful part of treatment and one of the concerns of patients during HD.[14] The most common cause of stress and pain in HD patients is insertion of needle into the AVF, which is attributed to the diameter and length of the needle; patients undergoing HD frequently encounter this annoying phenomenon.[15]
The pain from the needle, similar to the pain experienced after surgery, is classified in the acute pain group.[16] Frequent pain without relief or frequent severe pain causes stress, fear, and depression and decreases the quality of life of the patients. Given the high frequency of this painful procedure, and because of the chronic nature of the disease and the need for long-term therapeutic measures, it becomes necessary to relieve and reduce pain.[13] As compared with other members of the health-care team in clinical centers, nurses spend more time with patients, and thus they play a key role in relieving pain[17] and can apply several methods to reduce pain.[18] There is no unique and standard method to relieve this pain.[19] In previous studies, various methods have been used to control the pain caused by cannulation including application of topical anesthetic creams,[20] cold,[21] heat,[3] distraction methods,[21] lidocaine gel,[20] and lavender essential oil fragrances.[22] The skin is protected by the stratum corneum, and hence it is highly permeable to local anesthetics. Research has shown that the topical anesthetic creams are effective in reducing the pain caused by cannulation of the AVF.[13] The mixture of lidocaine 2.5% and prilocaine 2.5% is used as a topical anesthetic drug,[23] which makes changes in cell membrane depolarization toward the sodium ion and blocks the conductivity of nerve impulses; it penetrates healthy skin and leads to analgesia in several millimeters of the surface layer of the skin.[24]
Nowadays, the use of nonmedicinal methods for pain control has attracted more attention.[25] Cryotherapy is one of the oldest and affordable nonmedicinal methods to relieve pain. Among cooling materials, ice is a well-recognized anesthetic which is frequently used in emergencies such as fractures, sprains, and other inflammatory conditions.[26] Melzack introduced the gate control theory of pain to explain the mechanism of pain relief by cryotherapy.[27] Cold often has a cooling effect on surface tissues and causes physiological changes. These changes include vasoconstriction, decreased metabolism, muscle cramp and inflammation, and reduced pain sensation. Although cellular events resulting from the cold are not fully understood, cryotherapy rapidly reduces the metabolism through the reduction of temperature.[28],[29]
Pain relief and alleviation is the base of nursing care.[30] Given the known effects of cold compress and Xyla-P cream in pain relief, particularly, on the pain caused by the insertion of the needle, this study was designed and conducted aimed to compare the effects of Xyla-P cream and cold compress on the severity of the pain caused by the cannulation of the AVF in HD patients.
| Materials and Methods | | |
This randomized, clinical trial was conducted on 50 patients admitted to the dialysis center of Shohada Hospital, the only referral center for HD patients in Quchan city located in the North-East part of Iran in 2016. The main inclusion criteria were as follows: Age >18 years, being conscious of time, place, and persons at the time of data collection, undergoing HD at least twice a week, having fistula for at least three months, absence of damaged skin in the desired position, not having a known allergy to local anesthetics, not using alcohol or drugs as confirmed by a physician, having a minimum level of literacy, and lack of a history of mental illness as confirmed by a physician. Exclusion criteria were as follows using anesthetics in the past 24 h, patient's refusal to continue participation in the research, and death of patients.
To control the potential confounders, all stages of cannulation of the fistula were performed by a nurse. Needles used were similar in terms of size, shape, and the manufacturer company. Moreover, in this study, the people in charge of data collection and data analysis were blinded to the groups of study. A demographic questionnaire and a pain scale ruler were used as data collection tools. The pain scale ruler was graded from 0 to 10, where 0 indicated no pain and 10 indicated the most intense level of pain. The validity and reliability of this standard tool have already been confirmed by various studies.[31],[32]
Among the 80 patients treated with HD, 30 were excluded (27 patients did not met the inclusion criteria and 3 patients declined to participate); the remaining 50 eligible patients were randomly selected and enrolled in the study after obtaining a written informed consent. In this study, three interventions were used including the application of an ice bag with the body temperature (placebo), topical application of Xyla-P cream, and the cold compress (ice bag) [Figure 1]. | Figure 1: The process and flow diagram of the study design.
Analyzed (n = 50). ?: Excluded from analysis (give reasons) (n = 0).
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Patients were selected using simple random sampling method. The order of treatments was determined randomly by drawing lots, and consequently, all patients received placebo, Xyla-P cream, and cold compress intervention, respectively. The first round of assessment was performed on patients using the placebo. Patients completed the demographic questionnaire and were trained on the use of the pain ruler. The pain intensity was measured after inserting the needle; this process was performed over two successive HD sessions without any intervention, just through the application of an ice bag with the body temperature as the placebo. After a week of washout, the pain intensity was measured in patients who underwent intervention through Xyla-P cream; it was also performed over two successive HD sessions. The Xyla-P cream was applied 10 min before inserting the needle and was applied over an area of 5 cm around the place of fistula. Subsequently, using water, the cream was removed from the patient's skin and the desired place was disinfected for cannulation. After a week of washout to eliminate the effect of the previous intervention (intervention with Xyla-P cream), cold compress (ice bag) was applied on the place of cannulation; this process was performed on two successive sessions on the same group of patients. Again, the intensity of pain after cannulation was measured and recorded.
The demographic characteristics in all groups were reported as the mean ± standard deviation or number (%). The mean scores of pain were analyzed through analysis of variance for repeated measures and multiple Bonferroni post hoc test.
This study was approved by the Ethics Committee of Shahroud University of Medical Sciences (ethics code: 1395.19). In addition, this study was registered in the Iranian Registry of Clinical Trials (IRCT code: 2016050427744N1). The study was conducted in accordance with the ethical principles regulated by the Declaration of Helsinki and the guidelines of the Iranian Ministry of Health and Medical Education.
| Results | | |
A total of 50 patients were enrolled in this study. Of them, 27 patients were male (54%) and 23 were female (46%). The mean age of the patients was 50.16 ± 14.74 years. Hypertension alone and together with diabetes (90%) was the most common etiology of the disease in the patients under the study. [Table 1] presents the demographic characteristics of the studied patients.
[Table 2] presents a comparison of the scores of pain caused by the insertion of needle into the AVF in the placebo group, after using the Xyla-P cream, and after the use of cold compress (ice bag) in the study group. | Table 2: Bonferroni Test results to compare pain intensity after needle insertion between the three groups.
Click here to view |
The mean score of pain caused by the insertion of needle in the AVF in the studied patients was 6.68 ± 1.49 in the patients taking the placebo, 4.99 ± 1.27 after the use of the Xyla-P cream, and 4.11 ± 1.45 after the application of the cold compress. Based on the results of repeated measures ANOVA and multiple Bonferroni post hoc test, there was a significant difference between mean pain scores of the placebo group and Xyla-P cream group (P <0.001) and cold compress group (P <0.001). In addition, there was a significant difference between mean pain scores of Xyla-P cream group and the cold compress group (P <0.001) and a higher level of pain relief was observed in the cold compress group [Table 2]. Overall, the results showed that Xyla-P cream and cold compress both were effective in relieving the pain caused by the cannulation of the AVF; however, after the use of cold compress and Xyla-P cream, the intensity of pain became different between the two groups.
| Discussion | | |
The mean age of the participants was 50.16 ± 14.74 years. In Celik's study (2011), which was conducted to compare the effects of vapocoolant and lidocaine/prilocaine cream on the reduction of pain of cannulation in HD patients, the mean age of the patients was 57 ± 13.3 years, which is similar to our study.[13] Since the most common causes of ESRD are diabetes and hypertension, the prevalence of these diseases increases with age.[33] Hence, the prevalence of CKD increases with age. In the study of Bagheri-Nesami et al in 2013, hypertension alone or together with diabetes was identified as the most common cause of CKD[33] that is in line with the results of our study.
Our study shows that the participants who received placebo without any other intervention experienced a moderate level of pain during the insertion of the needle into the fistula. This finding is consistent with the results of the study by Bagheri-Nesami et al; they found that the score of pain experienced when inserting a needle into the fistula was a moderate one (4.16 ± 0.32).[34] In another study by Kaza et al in 2014, in many patients, the pain score was moderate (60.9%).[35]
In this study, pain intensity in the Xyla-P cream group was significantly lower than that in the placebo group. Agarwal et al reported in their study that the score of pain caused by intravenous cannulation in the group receiving a mixture of local anesthetics was about 63% lower than the pain score in the placebo group (Patch petroleum jelly);[36] it is consistent with the results of this research. Bahrami et al, in 2010, conducted a study aimed to investigate the effect of lidocaine patch in reducing the pain caused by electromyography needle insertion; they found that the lidocaine patch was effective in reducing the pain caused by electromyogram needling, as the pain score was 6.11 ± 12.07 in the control group and 4.62 ± 2.14 in the experimental group (P <0/05).[37] In this study, there was a significant difference between pain scores in the placebo group and cold compress group. Melzack et al conducted a study on patients with dental pain, and the findings showed that a cold compress massage (cryotherapy) between the thumb and the index finger at the site of pain resulted in a reduction of pain.[27] Hassan et al, Sabitha et al, and Aghajanloo et al investigated the effects of cryotherapy on pain intensity in patients undergoing HD fistula cannulation; the results showed the positive effects of cryotherapy on the reduction of pain at the site of fistula which is in line with the results of the present study.[26],[38],[39]
In this study, pain intensity in the cold compress group was significantly lower than that in Xyla-P cream group. Farnia et al compared the effect of Emla cream and cold compress on the pain intensity caused by the injections of enoxaparin. In their study, they allocated patients to three groups: Emla cream, cold compress, and control. They showed that cold compress was more effective in decreasing the pain intensity than Emla cream, which is in accordance with the results of the present study.[23]
Our results suggest that cold compress is more effective than Xyla-P cream in relieving the pain caused by the cannulation of AVF in HD patients. Therefore, it can be recommended to use cold compress as an easy way to reduce pain during the cannulation of AVF in HD patients.
| Acknowledgment | | |
This article was extracted from a master thesis conducted by a graduate student in intensive care in Shahroud University of Medical Sciences; the thesis was approved as a research project. Therefore, researchers would like to express their thanks to the research deputy, supervisors, and personnel working in the dialysis center of Shohada Quchan Hospital who kindly helped the researchers to collect the required data. We also would like to express our thanks to all hemodialysis patients who participated in this study.
Conflict of interest: None declared.
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Correspondence Address:
Dr. Hossein Ebrahimi
Randomized Controlled Trial Research Center, Shahroud University of Medical Sciences, Shahroud
Iran
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/1319-2442.229265
[Figure 1]
[Table 1], [Table 2] |
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