| | The Effect of Cold Application in Combination with Standard Analgesic Administration on Pain and Anxiety during Chest Tube Removal: A Single-Blinded, Randomized, Double-Controlled StudyReceived 29 December 2008; received in revised form 4 September 2009; accepted 24 September 2009. published online 31 May 2010. Abstract The aim of this study was to investigate the effect of cold application on pain and anxiety during chest tube removal (CTR) in patients who had undergone cardiac surgery. A single-blinded randomized design was used in this study. Ninety patients aged 18-74 years, hospitalized in the intensive care unit (ICU), who had a chest tube for a duration of at least 24hours were used for this convenience sample. The application of cold, placebo, or control therapies was randomized into three different groups. Sixty minutes before CTR was scheduled, an ICU nurse administered 10mg/kg paracetamol intravenously to all study subjects. Cold and warm packs covered with gauze dressing were applied to the area surrounding the chest tubes for 20minutes. Pain intensity, pain quality and situational anxiety for CTR were measured. Variance analysis and the latent growth model were used in the analysis of the data. Patients in the cold group had significantly lower pain intensity than the placebo group. The perception of pain intensity measured by visual analog scores of patients in the cold group showed the least variation. There was no statistically significant difference in McGill Melzack Pain Questionnaire scores or in change of anxiety level between the three groups. The application of cold prolonged the length of time until analgesics were needed after CTR. Results showed that cold application reduced patients' intensity of pain due to CTR but did not affect anxiety levels or the type of pain. Cold application is recommended as a pain-relieving technique during CTR. Chest drains are inserted in a wide range of situations, such as after cardiothoracic surgery, trauma, postoperative complications, and other medical conditions, to drain air, pus, or fluid from the lungs (Bruce et al., 2006, Puntillo and Ley, 2004, Sauls, 1999, Sauls, 2002). These chest tubes are typically removed 24-48 hours after surgery or when the excess air, blood, or fluid has been properly drained (Friesner et al., 2006, Singh and Gopinath, 2005). During the time the chest tube remains in place, the endothelium that lines the chest cavity adheres to the tube. When the tube is removed, the pulling force may shear those adhesions and cause pain (Friesner et al., 2006). Chest tube removal (CTR) can be both a painful and a frightening experience for the patient (Bruce et al., 2006, Mimnaugh et al., 1999, Singh and Gopinath, 2005), and care should be taken to make the procedure occur with as little pain and distress as possible (Bruce, Howard, & Franck, 2006). The removal of chest tubes has been described as one of the worst experiences in the intensive care unit (ICU) for these patients (Friesner et al., 2006, Houstons and Jeserum, 1999, Sauls, 1999, Sauls, 2002). Generally, patients describe CTR as a painful event in their postoperative recuperation and report that the pain from the procedure is poorly managed (Bruce et al., 2006, Puntillo and Ley, 2004, Sauls, 1999, Sauls, 2002). The management of pain, which is one of the oldest human needs, is a high priority for nursing care (Brouscious, 1999). Indeed, the Joint Commission standards indicate that relief of pain is a human right that includes the expression of pain, appropriate assessment and management of pain, and recognition that pain is subjective and should be attended by health professionals with expertise in assessment and management of pain (Brennan, Car, & Cousins, 2007). Therefore, because the use and removal of the chest tube is an important medical treatment, it is of great importance to bring under control the pain caused by the chest tube especially when it is removed, which according to research is intense and causes great discomfort. According to the literature, much research has been carried out on controlling the pain experienced when the chest tube is removed. To date, researchers have examined (in addition to the usual opioid pharmacotherapies) the effectiveness of music (Brouscious, 1999), medication (Carson et al., 1994, Puntillo, 1996), “quick relaxation” (Houstons & Jeserum, 1999), slow breathing relaxation exercises (Friesner, et al., 2006), ice therapy (Sauls, 2002), and/or topical analgesics applied to chest tube sites (Singh & Gopinath, 2005) to decrease the intensity of pain associated with CTR. Previously, researchers have tested the effects of nonpharmacologic interventions on decreasing patients' pain during CTR. Brouscious (1999) used a randomized controlled design to compare white noise, music of the patient's choice, and control (no music) for chest drain removal pain in 156 adults. There was no difference in pain between the three groups at any stage, and all three groups experienced a significant increase in pain during the procedure. The effect of a relaxation technique taught to patients before chest drain removal was studied in a nonrandom sample of 24 adults (Houston & Jesurum, 1999). Patients in both the treatment and the control group (no relaxation) received the same explanations and were given 50-75mg intramuscular meperidine (pethidine) 40-60minutes before the procedure. There was no difference in pain between the two groups. The effectiveness of ice was compared with placebo for chest drain removal pain in 50 adult patients (Sauls, 2002). Patients rated their pain intensity and distress using 0-10 numeric rating scales and their pain quality using the Short-Form McGill Pain Questionnaire (Melzack, 1975). There was no difference in pain scores between the two groups. Premedication was not standardized, but it was evaluated in secondary analyses and did not show any effect. Nevertheless, the effects of nonpharmacologic interventions on procedural pain are still not clear. Clarification of this issue is a prerequisite for making evidence-based decisions concerning the possible use of nonpharmacologic interventions on decreasing patients' pain during CTR. The nonpharmacologic approach to pain management includes a wide variety of techniques that not only address the physical sensations of pain, but also attempt to prevent suffering by enhancing the psychoemotional and spiritual components of care (Yavuz, 2006). Cold applications are commonly used as a nonpharmacological method for relieving pain (Alpar et al., 1997, Potter and Perry, 2005, Taylor et al., 2008, Yavuz, 2006). Studies have shown that application of cold can result in pain control and can increase the threshold for pain (Bleakley et al., 2006, Koç et al., 2006, Raynor et al., 2005, Sarifakioğlu et al. 2004, Sauls, 1999, Yağız, A. O, 2006). Several studies report that application of cold reduces postoperative pain and the need for opioid analgesics (Barber et al., 1998, Brandsson et al., 1996, Raynor et al., 2005). Ross and Soltes (1995) showed that when ice was applied before subcutaneous heparin injections, the subjects' perceived pain was significantly reduced compared with subjects who did not receive cold therapy. Application of cold has also proved to be efficacious when used to relieve pain due to other heparin and other subcutaneous injections (Kuzu and Uçar, 2001, Ross and Soltes, 1995), to relieve pain in patients with postelectroconvulsive therapy headaches (Drew, 2005), after surgery (Brandsson et al., 1996, Holmström, 2005; Ivey, Johnston, & Uchida, 1994), and after third molar extraction (Filho et al., 2005). Cold application also can result in decreased use of pain medications (Konrath, Lock, Goitz, & Scheidler, 1996) after procedures. Besides being a simple and inexpensive therapy, cold application has been accepted for decades as an effective nonpharmacologic intervention for pain. The analgesic effects of application of cold can be explained by Melzack and Wall's (1965) Gate Control Theory. In 1965, Melzack and Wall, motivated by deficiencies in the specificity theory, published a new theory of pain mechanisms. The Gate Control Theory of pain is based on the premise that a gating mechanism in the dorsal horn of the spinal cord can inhibit transmission of nerve impulses to the brain (Melzack & Wall, 1965). According to the Gate Control Theory, the stimulus of CTR activates fibers within the parietal pleura, chest muscles, and chest tube insertion site. It is believed that the activation of these pain-transmitting fibers results in a release of various excitatory neurotransmitters. The Gate Control Theory asserts that pain has physical, affective, and cognitive components; cold application is believed to influence the affective component of pain. Application of cold may lead to a reduction in or reversal of the pain impulse by activating descending inhibitory neurons that block ascending nociceptive nerves originating in the substantia gelatinosa. So this blocking of ascending nerve impulses “closes the gate” to pain, and the brain will not interpret the impulse as painful. The gate may also close when anxiety is reduced; this can lead to a decreased perception of pain (Friesner et al., 2006). There has been little research to identify the efficacy of methods other than pharmacologic treatment for reducing pain associated with CTR. This is of concern to nurses who are primarily responsible for preparing patients for procedures such as CTR, because these nurses have an ethical obligation to ensure that patients are made as comfortable as possible at all times (Houstons & Jeserum, 1999). Nurses have primary responsibility for preparing patients for painful procedures that occur during hospitalization (Gift et al., 1991, Houstons and Jeserum, 1999). The use of cold application could be a potential solution for reducing pain associated with CTR. Although analgesic agents are the most commonly used intervention for pain relief during CTR, researchers have stated that the response to pharmacologic treatment is variable and frequently does not result in sufficient relaxation, rendering pain management more difficult during and after CTR (Brouscious, 1999, Friesner et al., 2006, Houstons and Jeserum, 1999). Therefore, during and after a painful procedure such as CTR, the use of pharmacologic agents should be considered as well as a combination of these with nonpharmacologic interventions to improve pain management. The use of ice is also supported by the theory that ice decreases nerve conduction velocity and increases pain intensity. Although other findings are controversial, there is enough evidence to suggest that the use of ice could be a potential solution for this painful but frequently performed clinical procedure. Also of note regarding CTR is the fact that the procedure is not only painful but also anxiety producing (Gift et al., 1991, Houstons and Jeserum, 1999, Mimnaugh et al., 1999, Puntillo and Ley, 2004). Nurses must help patients manage anxiety during CTR, because anxiety is distressing for patients, and higher levels of anxiety are predictive of poor outcomes. However, there is little research examining the relationship between anxiety and pain as it relates to CTR. Research Aims and Hypotheses The present research was conducted to examine the effect of the application of cold on pain intensity, pain quality, and anxiety levels during CTR in adult patients recovering from cardiac surgery or other sternotomy procedures. Hypotheses 1.Patients in the application of cold group will have significantly less pain intensity associated with CTR than those in the placebo group and control group. 2.Patients in the application of cold group will have significantly less anxiety level during CTR than those in the placebo group and control group. Research Design and Methods  A single-blinded randomized experimental design was used in this research. The study was conducted at the cardiovascular and thoracic surgical intensive care unit at Ege University Hospital in İ zmir, Turkey. Participants A convenience sample of 90 patients hospitalized in the cardiovascular and thoracic surgical ICU between August 15, 2007, and June 1, 2008, and who had had a chest tube for a duration at least 24hours after cardiac surgery or sternotomy, was used for this protocol. Subjects were of Turkish nationality, aged 18-74 years (mean 53.40±14.04 years), spoke Turkish, were oriented to place and time, were able to report pain, had not received mechanical ventilation support, and had two mediastinal chest tubes or one pleural and two mediastinal tubes. Patients who had any psychiatric disease or an allergy to the paracetamol group of drugs, who did not speak or read Turkish, or who had any visual or hearing impairment were excluded from the study. Because effective application of cold in obese patients can take up to 30minutes, thereby affecting study results, only patients with a body mass index of <30kg/m2 were included in the study. Demographic information was collected from the patients' medical records regarding age, gender, medical diagnosis, specific type of cardiac surgery, specific type of chest tube (mediastinal or pleural), duration of chest tube placement, number and size of doses of and names of postoperative analgesics administered. Data Collection Pain intensity was measured by using a vertical visual analog scale (VAS) from 0 to 10, with high numbers meaning greater pain intensity. Validity of the VAS was established in a study of critically ill cardiovascular surgery patients (Puntillo, 1994). The McGill Melzack Pain Questionnaire (MPQ) was used to evaluate pain quality during CTR. Reliability and validity of the MPQ was previously established by Melzack (1975) and concurrent validity was established in Turkey by Kuğuluoğlu, Aslan, and Olgun (1998). The reliability coefficient of the tool for this study was r=0.81. The Spielberger Situational Anxiety Level Inventory (STAI-I) was used to measure anxiety levels, the concurrent validity of which was established in Turkey by (LaCompte & Oner, 1976). Procedures The Ethics Committees of the School of Nursing and Ege University Hospital approved the research protocol. Verbal and written informed consent was obtained from each of the patients for the present study. A simple randomization method was used to select patients for groups for the study to prevent conscious or unconscious manipulation in selection. Patients who conformed to the rules for admission to the study were assigned to one of three groups: Group A: cold application group. Group B (control 1): warm application group. Group C (control 2): group without application. Earlier studies have shown differences in pain perception and response to analgesics in patients according to gender and age (Güneş, Ü., Eşer, İ., & Khorshid, L, 2005, Houstons and Jeserum, 1999). In the present study, therefore, patients were equalized for gender (male and female) and age (18-38, 39-59, and 60-74 years). This was done to reduce the effect of age and gender on the study results and thereby to increase the reliability of the study. Assignment to the three groups (cold application group, warm application group or control group) was randomized. The researcher was responsible for the randomization and blinding of the study groups. On the first postoperative morning, patients' readiness for CTR was determined by a physician according to standard criteria. Patients were instructed by the researcher in the use of the VAS for rating pain intensity. Sixty minutes before CTR was scheduled, an ICU nurse administered 10mg/kg paracetamol intravenously to all study subjects. Cold packs were kept in a refrigerator at +4°C, and placebo packs were kept at room temperature at 18-22°C. Both cold and placebo packs were covered with gauze, and applied to the area surrounding the chest tubes for 20minutes. Pain intensity was measured and situational anxiety of the patients was evaluated 10minutes before CTR. All patients were reassured that analgesic drugs would be administered as needed. All chest tubes were removed by the same ICU physician, providing for reliability of study results. The steps in the applications to patients included in the study were as follows. Data Analysis Power analysis was used to determine sample size. Using the VAS to distinguish results between the applications with a power of 81%, and to achieve the difference between the time periods evaluated with a power of 100%, it was determined that a sample size of 90 (30 each for cold application, placebo application, and control groups) was sufficient for this study. Data analysis was performed using SPSS version 11.0 for Windows software and the LISREL program. Methodologies used include the variance analysis model (ANOVA-MANOVA) and latent growth modeling (LGM). The conceptual movement to examine behavior from both developmental and contextual perspectives parallels recent methodologic advances in the analysis of change. These new analysis techniques have fundamentally altered how we conceptualize and study change, and have prompted researchers to identify larger frameworks to integrate knowledge. One such framework is LGM, a technique that provides a method to model individual differences in growth curves (Duncan & Duncan, 2004). LGM allows for assessment of individual change as well as the differences between individuals; it uses all available data points and explicitly models measurement error (Stull, 2008, Aşkar & Yurdugül, 2009). Latent growth modeling results in a change trajectory for perceived pain of patients obtained at three different time points. As shown in Figure 1, there is a change in the pain trajectory for every patient. In this study, we analyzed the pain trajectory of the three groups and compared them to determine the most improved pain change trajectory. The VAS did not always result in a consistent linear structure, which provided the rationale for using LGM for identification of these trajectories. In the present study, the perception of pain measured at three different time points was examined as an independent variable, as was the change in level of pain intensity of patients. In the LGM, there are two psychologic structures, the first of these, in the beginning of the procedures, showing the patients' perceptions of pain (constant), with measurements showing changes in pain levels. This model allows for dissimilarity of the changes in pain perception that arises from the individual characteristics; standardized factors loading the pain index measurements are shown in Figure 2. Results The age of the study participants ranged was 18 to 74 years (mean 53.40, SD 14.04 years). The study sample consisted of 53 men (58.9%) and 37 women (41.1%). There were no significantly different demographic or clinical characteristics in the three groups (p < .05). Approximately half (52.2%) of the patients had undergone a coronary artery bypass graft (CABG) procedure, and 27 patients had had valve procedures. Also, 51.1% of patients had two mediastinal tubes, and 48.9% had two mediastinal tubes and one pleural tube for a total of three tubes. Mean (SD) scores for pain intensity before, immediately after, and 15minutes after CTR in the three groups are shown in Table 1. Application of Cold Group Using LGM, the goodness of fit index (GFI) was 0.94, the comparative fit index (CFI) was 0.96, and the root mean square error of approximation (RMSEA) was 0.00. These measurements demonstrated the validity and reliability of LGM for the present study (Yurdugül, 2007). Accordingly, the perception of pain intensity measured by VAS scores of patients in the cold application group revealed a systematic variation. Using factor loading, results of VAS-1 0.16, VAS-2 0.18, and VAS-3 0.08 were obtained. Ten minutes before the procedure, there was a very slight increase in pain perception, and immediately after and 15minutes after the procedure, VAS measurements showed a decrease in pain intensity (Fig. 3). The covariance between the perception of pain at the beginning of the application (constant) and alteration speed (alteration) was 13.75. Accordingly, patients with a high level of perceived pain at the beginning of cold application also reported high levels of pain after the procedure. Placebo Group Latent growth modeling for the placebo group revealed GFI 0.95, CFI 0.98, and RMSEA 0.05, thereby demonstrating the validity of the model (Yurdugül, 2007). In this group, there was a low level of perceived pain for the first measurement (VAS-1 0.10), but immediately after CTR, pain perception increased by a relatively large amount (VAS-2 0.81) compared with the cold application group. Pain in the placebo group was reduced (VAS-3 0.31) 15minutes after CTR, but it was still higher than that of the cold application group for the same time measurement (VAS-3 0.08). The covariance (with alteration speed) between the pain perception before application (constant) and alteration speed (alteration) was −0.60 for the placebo group (Fig. 4). Control Group The LGM for the control group yielded the following measurements: GFI 0.98, CFI 01.00, and RMSEA 0.00. Although in this group there was a low pain perception at the time of the first measurement (VAS-1 0.06), immediately after CTR pain increased by a relatively large amount (VAS-2 1.29) compared with the cold application and placebo groups. Fifteen minutes after the procedure, measurement showed a reduction in pain (VAS-3 0.27). The covariance (with alteration speed) between the pain perception in the beginning of the application (constant) and alteration speed (alteration) was 0.70 for the control group (Fig. 5). For a presentation of all pain trajectories, see Figure 3, Figure 4, Figure 5. As seen in Figure 6, the perception of pain intensity measured by VAS scores of patients in the cold application group showed the least variation, followed by the control group. There was no statistically significant variation in difference of perceived pain intensity when analyzed according to variables such as age, gender, or number of chest tubes in the cold application group (p > .05). Discussion It was observed that the VAS scores obtained 10minutes before CTR was similar in the three groups, whereas the VAS-2 scores obtained immediately after CTR were higher than other scores obtained for other time points. The VAS scores obtained 15minutes after CTR in the cold application group produced the most improvement in pain. Also, perceived pain was the most intense during CTR (VAS-2), a result in agreement with other studies (Brouscious, 1999, Friesner et al., 2006, Owen and Gould, 1997, Puntillo, 1996, Sauls, 1999, Sauls, 2002). As expected, VAS-2 of the patients in the placebo group (room-temperature packs) were observed to be higher than in the cold application group and lower than in the control group, indicating that pain perception in the placebo group was lower than pain perception in the control group. This positive response of patients to placebo can be explained by the patient's desire to experience less pain. Our finding is in agreement with those found in the literature indicating that placebo affects pain perception (Bal, 2002, Kocaman, 1994). Similarly, the placebo group showed the greatest variability. Pain perception according to VAS measures changed the least in the cold application group (Fig. 6). According to the results obtained in this study, the application of cold was the most effective in relieving the pain associated with CTR. As is known, free nerve endings are present in the superficial layer of the skin (Kuzu, 1999). According to Puntillo (1996), the CTR procedure is a painful stimulant for parietal pleura, pectoral muscles, and other types of fibers, including intercostal nerve fibers into which the chest tube passes, leading to acute and superficial CTR pain. Indeed, the application of cold blocked pain perception by affecting nociceptors. In both laboratory and clinical research, it has been suggested that application of cold causes a reduction in nerve transmission speed (Paddon-Jones & Quigley, 1997). In this context, application of cold can be an especially important nonpharmacologic nursing intervention for pain management. In the only other previously published study relating to pain intensity associated with CTR, Sauls (2002) concluded that topically applied ice for alleviating pain intensity during CTR was not effective. This is in disagreement with the results of the present study. These differences may be explained by differences in the parameters of the current study: application of cold for 20minutes, double-controlled randomized trial, and appropriately powered sample, as opposed to those in the Sauls study. Finally, the present results showed that the application of cold is effective in reducing the pain intensity associated with CTR at a statistically significant level in which patients currently experience a moderate level of pain (6.77±2.33) after CTR. It was observed that although this result, showing that a reduction in pain experienced by the cold application group throughout the removal of the chest tubes was statistically significant, patients in that group still experienced pain at a medium level (6.77±2.33). Pain is known to be a subjective experience with a dynamic interplay of sensory, perceptual, and cognitive systems. Thus, pain is a multidimensional sensation which each person experiences differently. It includes a blend of neurophysiologic, biochemical, cultural, cognitive, and environmental dimensions (Kocaman, 1994; Kuğuluoğlu 2006), and there is no doubt that in the control of pain, an individual's perception of pain is affected by a variety of personal and environmental factors. For this reason, it is felt that the evidence value of the statistically significant results obtained in the present study should be strengthened by further studies of combinations of pharmacologic and nonpharmacologic methods. Pain is a multidimensional subjective experience that involves the interaction of sensory, perceptual, and cognitive conditions. Undoubtedly, pain management must also take into consideration individual and environmental factors that are known to affect the perception of pain. The literature contains studies citing factors such as age, gender, and culture that may affect pain perception (Gift et al., 1991, Güneş, Ü., Eşer, İ., & Khorshid, L, 2005, Houstons and Jeserum, 1999, Puntillo, 1996). In the present study, however, age, gender, and number of chest tubes were not found to be significant variables. Anxiety In the literature, there are only a few studies related to anxiety associated with CTR, and none were found on the effect of the application of cold on such anxiety. Mimnaugh et al. (1999) found that anxiety levels were high in 77% of patients during CTR. Gift et al. (1991) stated that the CTR procedure induces anxiety. In the present study, patients experienced high anxiety levels before CTR and moderate anxiety levels immediately after CTR. There was no statistical difference in the variation of anxiety of patients among the three groups. There was also no statistically significant difference in the number of analgesics required after CTR between the three groups (p > .05). There was, however, a statistically significant difference in the duration of need for analgesics after CTR between the three groups (F=6.510; p < .05). The application of cold seemed to prolong the length of time between analgesic doses after CTR, possibly owing to decreased pain perception. The MPQ words selected most often by subjects in this sample were “terrible” and “stinging.” In earlier studies on CTR, the frequency of selection of “terrible” from the MPQ varied considerably. Sauls (2002) found that “terrible” was chosen less often than another affective descriptor, “punishing-cruel.” In a study by Puntillo (1994), >50% of 18 patients selected “terrible” as the descriptor of their pain during CTR. The presence of anxiety may increase the perception of fearfulness during CTR. Limitations Because this study was limited to patients who underwent cardiothoracic surgery, results cannot be generalized to all patients undergoing CTR (i.e., for reasons other than cardiothoracic surgery). Patients' perceptions of pain intensity, pain quality, and anxiety can also be affected by environmental factors such as noise, light, procedures, and treatments administered to other patients hospitalized in the same ICU and not controlled by the researchers. Conclusions and Next Steps Results showed that application of cold packs reduced the intensity of pain due to CTR but did not affect anxiety levels or pain quality. Cold application, a nonpharmacologic intervention, is recommended as a pain relief technique during CTR. Nurses make important decisions regarding application of nonpharmacologic therapeutic interventions for pain management. Future studies should investigate the effects of cold application combined with different pharmacologic and nonpharmacologic therapeutic techniques. Acknowledgments The authors are grateful to: research assistant Esma Canli, a student at Ege University, Prof. Dr. İsa Durmaz, head of Thoracic and Cardiovascular Surgery Clinic, Ege University Hospital, and Dr. Fatih Ayik, thoracic and cardiovascular surgeon, for their expert assistance. References Alpar et al., 1997. 1.Alpar Ş, Atalay M, Çakırcalı E, Çeviker GVA. Hemşirelik esasları el kitabı [Fundamentals of nursing handbook], Vehbi Koç Vakfi Yayinlari. Vol. 8. Istanbul: Baski, Birlik Ofset; 1997;. Aşkar & Yurdugül, 2009. 2.Aşkar P, Yurdugül H. The using of latent growth models for educational researches. 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PII: S1524-9042(09)00104-0 doi:10.1016/j.pmn.2009.09.002 © 2010 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved. | |
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