A Pilot Study: Effects of Ice Therapy on Vascular Access Site Pain Following Atrial Fibrillation Radiofrequency Catheter Ablation

Abstract

Background: Nurses at our institution occasionally apply ice for pain management at vascular access sites after radiofrequency ablation (RFA). Objective: To assess the effects of ice on vascular access site pain, pain medication administration, patient satisfaction with pain management, and minor and major vascular access complications as a means of valuable information to help guide evidence-based nursing practice. Methods: An experimental research design was used to test the intervention of ice application at femoral vascular access sites at a Midwestern academic center. Ice was applied for 20 minutes before sheath removal and again for 20 minutes after hemostasis. A visual analog scale (VAS) was used to collect numeric responses measuring patient pain and satisfaction. Major vascular complications were measured twice — once during hospitalization and again at a 2-week phone follow-up. Results: A total of 103 atrial fibrillation (AF) RFA patients were enrolled in this study; 51 were randomly assigned to the intervention group and 52 to the control group. Significant findings were identified in the intervention group: reduction in reported pain at sheath removal (18% vs. 35%; P=.05); receipt of less midazolam than control group at sheath removal (P=.05); and receipt of less total medication (fentanyl, P=.03; midazolam, P=.009; and acetaminophen/oxycodone, P=.05) from 20 minutes before sheath removal to 6 hours after hemostasis. Conclusions: Findings from this pilot study suggest that ice application immediately before and after sheath removal may reduce both pain and the overall use of pain and anxiolytic medications in the AF population with RFA.

Keywords: antianxiety agents; atrial fibrillation; catheter ablation; pain; ice 

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Introduction

Atrial fibrillation (AF) is the most commonly diagnosed sustained arrhythmia, and its incidence continues to increase. One treatment option available to patients with a diagnosis of AF is percutaneous radiofrequency ablation (RFA). This procedure involves the disruption of abnormal electrical pathways.¹ During the procedure, multiple venous catheters and, usually, an arterial femoral catheter are inserted into the femoral veins and arteries, and electrical energy is directed into the heart muscle. This energy either disconnects or isolates the pathway of the abnormal heart rhythm, thereby reestablishing a normal rhythm or helping to control the heart rate in patients with problematic atrial arrhythmias.

The number of patients undergoing complex RFA procedures continues to increase. Ellis et al¹ reported that the annual number of procedures increased from 315 in 2001 to 1,975 in 2006. The research team also reported an overall increase in complication rates for RFAs from 6.7% in 2001 to 10.1% in 2006 (P=.01). The increase in complication rates was attributed mainly to vascular access site complications. A study by King et al² found that cold-pack application was effective in reducing femoral access site hematoma in patients with coronary angiography. Ice therapy also has been shown to decrease the occurrence of hematoma with subcutaneous heparin injection.³

Frequently, patients undergoing percutaneous cardiac procedures report pain at the vascular access site.⁴ Nursing has the ability to influence patients’ report of pain using non-pharmacological interventions. Manual compression during pull, elimination of sandbag use, and shortened bed rest all may increase patient comfort post procedure.^2,5,6 Currently, ice is used intermittently as an intervention to assist with pain reduction, but there is no evidence that it benefits this patient population with vascular access site pain. A research pilot study investigating the application of ice to the vascular access site before and after sheath removal could optimize pain management and support the use of ice as an effective and safe intervention. If outcomes indicate a reduction of pain with ice use, we could use this information to change the standard of nursing care for this patient population. 

Theoretical and Conceptual Framework

Several proposed theories suggest that ice as a pain reliever can be effective. Ice has been used in and out of the hospital for pain control related to surgical and traumatic injuries. Its application as a pain reliever is widely accepted, although the mechanism of how ice achieves pain relief is not clear. Some potential explanations for analgesia with ice may include, but are not limited to, a decrease in transmission of pain through the nerves; a decrease of inflammation and thereby an increase in the pain threshold; and the cold sensation overriding the pain sensation, also known as the gate control theory.⁷ 

In the gate control theory of pain, ice acts on nocicepters (pain receptors) to blunt the perception of other mechanical and chemical stimuli, including pain, by closing the “gates” to other sensations at the central nervous system. In accordance with this theory, ice applied directly to a pain stimuli site should decrease pain.^7,8,9 Other investigators propose that ice may work in the peripheral nervous system by decreasing the velocity of transmission in the nerve and thereby increasing the pain threshold and pain tolerance along the same nerve.⁷ Several theories may explain the physiological effects of ice in relation to pain control. One source states that ice application, along with pharmacologic interventions, can reduce adverse effects, improve outcomes, and decrease hospital stays.⁹ This same source also states that ice therapy decreases the need for dosing with opioids or narcotics, thus decreasing potential medication complications.

Use of ice application along with use of pharmacologic agents is accepted as effective treatment for pain in multiple specialties, particularly following acute sport injury and orthopedic surgery.⁷ Cold application for the treatment of acute and chronic pain is considered a nursing non-pharmacologic intervention.^10,11,12 Non-pharmacological methods such as distraction, humor, relaxation, cutaneous stimulation, and especially the use of cold, are important nursing interventions in alleviating pain.

Study Aims

We conducted the pilot study to determine the differences between the control group and the intervention group in the number of patients having pain and its severity at the vascular access site at 5 time intervals. In addition, we sought the percentage of participants using medication for pain and anxiety (including medications given 20 minutes before sheath removal and continuing until 6 hours after removal) and aimed to report satisfaction with pain control management at 12 to 16 hours after hemostasis.

The vascular access complications studied in this work included hematoma, bleeding, and major vascular access complications (pseudoaneurysm, arterial venous fistula, retroperitoneal bleed, and transient ischemic attack).

Literature Review

Most patients undergoing the femoral sheath removal report pain and discomfort associated with the vascular access site during the removal procedure.⁴ When researchers asked patients to describe their personal experience during and after cardiac catheterization, post-procedure pain and discomfort were 1 of the 4 main topics patients discussed.¹³ Investigators have learned that intravenous (IV) opioids and sedatives are effective in decreasing patient-reported pain and discomfort with cardiac procedures and during sheath removal, compared with local anesthetic or oral analgesia.^14,15 Puntillo et al⁴ studied pain in procedural patients at 169 institutions. They concluded that mild pain is associated with femoral sheath removal, and patients are more likely to receive IV opioids or sedatives before sheath removal regardless of whether the patient reports pain at that time.

Despite the active use of IV analgesics to treat and prevent pain associated with femoral sheath removal, many patients continue to have mild pain during the procedure, which indicates that further research can optimize pain management. Nurses believe that treating patient pain and discomfort is a priority after coronary angiography.¹⁶ However, little evidence is available about the effectiveness of nurse-initiated interventions targeted at pain control. More recently, researchers have begun to analyze non-pharmacologic nursing interventions targeted at procedural pain relief.

The use of ice and cryotherapy after orthopedic and maxillofacial surgery has been shown to decrease pain and swelling.^17,18 Ice therapies applied either before or before and after subcutaneous administration of low-molecular-weight heparin decrease the pain that patients perceive.³ King et al² looked at the use of ice in reducing hematoma size in patients after femoral sheath removal following post-cardiac intervention. Their study found that 97% of patients in the ice therapy group reported a decrease in discomfort and all patients in the ice therapy group reported that they would use ice therapy again. Nursing staff reported high patient satisfaction with ice therapy. McGowan and Power¹⁹ found that ice applied to a brachial catheter site decreased bruising, and they concluded that this therapy could translate into decreased patient discomfort because of a correlation between vascular access site complications and discomfort.

Despite the promising findings of ice therapy for decreasing discomfort and being beneficial in reducing hematoma size, more evidence is needed in this area. A current push toward increased quality of care among accrediting bodies and potential payers means assessing pain management effectiveness and outcomes. Health care systems and providers need to evaluate current pain management protocols to meet the expanding demands of regulatory bodies and to promote low-cost treatment options as appropriate.⁸ Because vascular access complications with AF RFA procedures have increased, it is a valuable effort to investigate the effect of ice therapy on pain and vascular access site complications. No prior studies have been done investigating the patient’s perception of pain with the use of ice therapy for the AF RFA population.

Methods

Design

An experimental research design was used to test the intervention of ice application to the vascular access sites for 20 minutes before removing the sheaths, and again for 20 minutes immediately after removal and hemostasis was achieved.

Setting and Patients

The study was conducted on an interventional cardiology unit of a large Midwestern medical center. In 2010, the electrophysiology laboratory at this pilot center conducted 976 total ablations, of which 486 were AF RFAs. The sample size was 103 patients who were randomly assigned to the intervention group (n=51) and control group (n=52). The sample size was chosen primarily from a practical standpoint; it could be accomplished with limited resources and within a reasonable time frame. The primary goal of the study was to collect data that could be used for setting up future studies. Before the study, we anticipated being able to detect a 2-point difference in pain scores. However, the variability in pain scores was less than expected. On the basis of the observed data, we had 80% power to detect a 1.5-point difference in pain scores. On the basis of the number of patients enrolled, this study had 80% power to detect a difference of 20% in proportion of patients experiencing pain.

Sample

The study sample was selected on the basis of the following inclusion criteria:

• Age 18 years or older
• A scheduled ablation with the goal of AF elimination
• Post-procedural care carried out on a dedicated cardiac interventional unit

The sample exclusion criteria were as follows:

• Pregnancy
• Imprisonment
• Medical complications resulting in urgent and unanticipated transfer to a critical care unit
• History of platelet dysfunction or known coagulopathy
• Inability for any reason to give informed consent, use of the visual analog scale (VAS), or respond to a telephone survey in English
• Active bleeding from the femoral arterial or venous puncture site that required early removal of the  sheath or manual pressure before the planned time of sheath removal
• Hematoma greater than 5 cm or requiring manual pressure on the femoral arterial or venous puncture sites before the planned sheath removal

Evaluation Instruments

A VAS was used to collect patients’ pain and satisfaction with vascular access site management. The scale was chosen for its simplicity and efficiency. The VAS measurement tool had a possible range of 0–10, with 0 being no pain and 10 being the worst pain they ever felt. In relation to satisfaction, patients were asked, “How would you rate overall satisfaction with vascular access site pain management?” Zero indicated not satisfied and 10 indicated satisfied. The VAS scale has been used with good reliability when measuring pain. The VAS provides a straightforward way to record the subjective estimates of pain.²⁰ 

In addition, a post-RFA data collection tool was developed and used to collect numerical data on vascular access site assessments, minor vascular access complications, major vascular access complications, and pain medication use. Data was collected retrospectively from the patient’s chart on the following two items: percentage of patients taking medications from 20 minutes before and up to 6 hours after sheath removal, and secondly, on vascular access site complications.

Recruitment

The present study was approved by the Mayo Clinic Institutional Review Board, and participation in the study was voluntary. All patients scheduled for an AF RFA were screened by study investigators for eligibility. All eligible patients were approached by study investigators the morning of the procedure for participation in the study. Enrollment occurred before the procedure, and the patients who met inclusion criteria were randomly assigned after the procedure. We used a randomization schedule, which was accessible via a password-protected internal website. This permitted patients to be evenly distributed among the intervention and control groups. A total of 138 patients were approached for enrollment; ultimately, 103 of these patients were enrolled in and completed the study.

Intra-procedure Data

Ten different electrophysiologists performed procedures for the study participants. Although each electrophysiologist had some differences in procedural practice, they followed a standardized method of delivering care intra-procedure. Patients received general anesthesia. After the vascular access site was prepped for the procedure, 5 to 7 mL of 1% lidocaine was administered and sheaths were placed with the modified Seldinger technique and ultrasound guidance. The sheaths may be manipulated and at times up-sized.

Patient vascular access included a minimum of 2 venous sheaths (diameter, 5–10 French) and a maximum of 1 arterial sheath (diameter, 4–8 French). In addition, 5 mL of 1% lidocaine was given subcutaneously to each groin site before general anesthesia was withdrawn and the patient left the procedure room. Patients were then taken to the recovery room before returning to their room for overnight admission.

Standard Post-RFA Procedure

After an ablation procedure, the standard of care requires that most patients be transferred to the interventional cardiovascular unit. The patient must remain supine with the head of bed (HOB) a maximum of 30 degrees while sheaths are in place. Patients are not allowed to move any extremity with a sheath and can only move head side to side while sheaths are in place. When the activated clotting time (ACT) value is equal to or lower than 180, the patient’s femoral access lines are removed. From insertion to removal, sheaths may be in place a total of 4–12 hours.

Commonly, patients experience some degree of pain with sheath removal and during bed rest afterward. Standard nursing practice after an AF ablation includes assessing patients for pain and administering pain medication as needed. It is an institutional goal for patients to have a pain rating of less than 4 (mild pain) on the numeric pain scale. In the present study, this rating was used to help the registered nurse determine when interventions were needed. Standard practice of care includes offering patients medications for pain, including fentanyl, morphine, acetaminophen/oxycodone, or acetaminophen, or a combination, in accordance with a physician order set. This standard of offering pain medications was also used for the pilot study. Another option on the post-RFA order set is midazolam, administered as needed for anxiety and muscle spasms. Midazolam is used frequently for patients after an RFA.

In accordance with our institution’s nursing procedural guideline, the sheath removal process involves the application of firm manual pressure over the sheath insertion site while gently removing the sheath from the groin. All venous lines are removed with minimal time between them. Firm manual pressure is held for 3 minutes. When venous hemostasis has been achieved, the arterial sheath can be removed. Occlusive pressure is held for another 3 minutes, with continued, but lessening, pressure applied for another 10 to 20 minutes.

After all sheaths have been removed and hemostasis achieved, standard practice entails the application of a non-compression adhesive strip with a gauze pad and the placement of the patient on flat bed rest. After 2 hours of flat bed rest, the head of the bed can be elevated to 30° maximum and the patient may turn to the arterial site side. After 3 hours, the patient is allowed to be in any position of comfort. The patient may cautiously begin ambulation with assistance at 4 hours after hemostasis.

Intervention Procedure

After the ablation procedure, all eligible study patients were transferred to the interventional cardiovascular unit. When the ACT value was 180 or less, the patients were randomly assigned through a Web-based tool to the intervention group or the control group.

The patients assigned to the intervention group received an ice application to the vascular access sites for 20 minutes before the sheaths were removed. To ensure consistency in timing of sheath removal, a 20-minute delay in the control group occurred from the time of randomization to the time of sheath removal. The ice intervention was delivered using Novaplus ice bags (Kimberly-Clark Health Care Inc.). Patients received ice therapy to all femoral sites, whether access was on one side exclusively or on both right and left sides. After sheaths were removed and hemostasis obtained, the intervention group received a second 20 minutes of continuous application of ice to all femoral vascular access removal sites.

Data Collection Procedure

Data collectors were registered nurses trained by the investigators in the conduct of study procedures and were not assigned to provide direct care to study patients. Inter-rater reliability among data collectors was established before the start of the study. The registered nurse who conducted the data collecting also assumed responsibility for removing the femoral vascular access sheaths, both arterial and venous.

Data regarding pain level and the condition of the vascular access removal site (i.e., hematoma and bleeding) were collected before sheath removal, at hemostasis, 1 hour after hemostasis, at 12 to 16 hours after hemostasis, and with a 2-week follow-up phone call. The VAS was used to collect data related only to pain at the vascular access sites. Hematomas were measured as a palpable firm area of 5 cm or more in diameter. External bleeding was defined as the presence of bleeding requiring manual compression at the vascular access site. Data from any occurrence of major vascular access complication (transient ischemic attack, pseudoaneurysm, arterial venous fistula, or retroperitoneal bleed) were collected at 1 hour after hemostasis, at 12 to 16 hours after hemostasis, and with a 2-week follow-up phone call.

A review of the electronic medical record allowed data collection of the amount and type of pain medication used from 20 minutes before and continuing for 6 hours after removal of sheaths. Data were reported in percentage of participants in groups taking medications. Data of other characteristics extracted from the electronic medical record included age, sex, weight, presence of hypertension or diabetes mellitus, previous AF ablation procedure, and systolic and diastolic blood pressure.

Data Analysis

Collected data were summarized separately for patients randomly assigned to the intervention and control groups. Categorical variables were reported as frequency and percent; continuous variables were reported as mean and standard deviation. Comparison of results between the intervention group and the control group was done for continuous variables using 2-sample t tests and for categorical variables using Pearson χ² or Fisher exact test as appropriate. Statistical analysis was done with SAS version 9.2 (SAS Institute Inc.). All analyses used 2-sided tests, and a P value less than or equal to .05 was considered statistically significant.

Results

Demographic Characteristics

Demographically, the study groups did not differ significantly, with the exception of gender; more males were enrolled in the study (82%) and were randomly assigned to the intervention group (P=.006) (Table 1). The national trend for AF has a greater occurrence in men than women. Nine patients refused participation when approached for enrollment and 25 patients did not meet inclusion criteria after the procedure, so these patients were excluded from the study (N=103).

Pain 

The VAS results showed mild pain for both groups at the time preceding sheath removal, with a mean (SD) score of 2.9 (1.3) in the control group and 3.0 (1.7) in the intervention group. This tendency continued at each time point and did not differ significantly (Table 2).

Data from the pilot study showed that patients in the intervention group were significantly less likely to report femoral vascular access site pain at the time of sheath removal than patients in the control group (18% vs 35%; P=.05). The percentage of patients reporting femoral sheath site pain at the 4 other points evaluated (at hemostasis, at 1 hour after hemostasis, at 12–16 hours after hemostasis, and with a 2-week follow-up phone call) did not differ significantly. However, the control group reported more femoral site pain at the 2-week follow-up (10% vs 2%; P=.10), though the difference did not reach statistical significance (Table 2).

Medication Use

Although data were collected on morphine and acetaminophen use, a minimal number of patients used acetaminophen and no patients used morphine during the study time frame. Of statistical significance, fewer patients in the intervention group received midazolam with the sheath removal procedure than in the control group (55% vs 73%; P=.05). More patients in the control group received fentanyl with the sheath removal procedure than patients in the intervention group (81% vs 65%; P=.07) (Table 3).

When comparing total medication used during the study time from 20 minutes before sheath removal to 6 hours after hemostasis, we found that patients in the intervention group were statistically less likely to receive fentanyl (P=.03), midazolam (P=.009), and acetaminophen/oxycodone (P=.05) (Table 3).

Satisfaction with Pain Management

Our study measured patient satisfaction with vascular access site pain management. Patient satisfaction was high (9.4 on the VAS) in both study groups, with no statistical difference noted.

Vascular Access Complication

Between hemostasis and the 2-week follow-up phone call, 9 hemorrhagic events and 3 major vascular access site complications occurred in the 103 patients enrolled in this pilot study. The 9 hemorrhagic events were composed of 5 hematomas and 4 re-bleeds. Of note, 4 of the 5 hematomas occurred between 38 hours after sheath removal and the 2-week follow-up call and 3 of the 4 re-bleeds occurred between 16 hours after sheath removal and the 2-week follow-up call. Although the rate of vascular access sheath removal complications (hematoma and re-bleed) in the control group was higher than in the intervention group (12% vs 6%), the rates did not differ significantly between the 2 groups. All 3 of the major vascular access site complications were pseudoaneurysms, with 1 complication requiring surgical intervention. In addition, all 3 occurred after discharge from the hospital and were reported at the 2-week follow-up phone call; 2 occurred in the control group and 1 occurred in the intervention group. No other clinical predictors of complications were identified in our data.

Discussion

Our findings suggest that ice intervention may decrease a patient’s femoral site pain at the time of sheath removal, may decrease the patient’s use of medications, and potentially contribute to a decrease in vascular access complications. This study, in similar manner to others, reported mild pain with the sheath removal procedure.^4,21 The use of ice in decreasing pain and discomfort is supported in several other studies.^2,3,17,18 As shown herein, ice decreased the number of patients reporting pain at the time of sheath removal but did not have a significant effect at other data collection times.

In our study, fewer patients in the intervention group used fentanyl and midazolam during the specific time associated with sheath removal. Throughout the total study collection time, we found a smaller number of patients in the intervention group used fentanyl, midazolam, and acetaminophen/oxycodone than in the control group. The use of sedatives and opioids for pain relief during and after sheath removal is common and accepted practice.^14,15,21 Our study suggests that the use of ice as an intervention to decrease pain may lessen the need for pharmacologic agents post-procedure.

Our findings affirm that patients are satisfied with pain management with or without the use of ice. Anecdotally, verbal feedback of the patients during the study was positive about the ice therapy (Table 4).

Our study did not show any statistically significant difference between the 2 study groups in relation to vascular access site complications or major vascular access site complications. Of the study groups, there was a tendency for those who received the ice to have fewer complications.

Limitations and Generalizability

This investigation was a pilot study with a small sample size, which limits its generalizability and the ability to show a difference between the groups. The number of male participants was significantly larger in the intervention group because randomization did not control for gender. The study was conducted at a single center. Practice related to post-procedure care at other centers may differ from the study site, and thus our results may not apply to other clinical settings.

A patient’s assignment status was not masked to the registered nurses involved with data collecting and sheath removal, a detail that could have led to potential bias.

Future Implications

More studies with larger sample sizes and diverse settings are recommended to determine whether the results found in this pilot study can be replicated. Future studies would help validate and identify decreased medication use that has beneficial implications on practice, including a decrease in patient adverse effects, cost, and nursing time used to administer medications to promote comfort. 

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Acknowledgments and Disclosures: This research was supported by the Mayo Clinic Heart Rhythm Services laboratory personnel and the interventional cardiac unit. The authors also acknowledge the data collection support of staff from the interventional cardiac unit and Tammy A. Kester, RN. Funding was received from Mayo Clinic Nursing Research and Evaluation Committee and Mayo Clinic Heart Rhythm Services. None of the authors report any conflict of interest with this work.