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(Radiology. 2000;215:684-688.)
© RSNA, 2000


Vascular and Interventional Radiology

Interventional Radiologic Procedures: Patient Anxiety, Perception of Pain, Understanding of Procedure, and Satisfaction with Medication—A Prospective Study1

Peter R. Mueller, MD, Sandip Biswal, MD, Elkan F. Halpern, PhD, John A. Kaufman, MD and Michael J. Lee, MD

1 From the Department of Radiology, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114 (P.R.M., S.B., E.F.H., J.A.K.), and the Department of Radiology, Beaumont Hospital and the Royal College of Surgeons, Dublin, Ireland (M.J.L.). Received March 25, 1998; revision requested June 19; final revision received September 14, 1999; accepted October 4. Address correspondence to P.R.M.


    Abstract
 TOP
 Abstract
 Introduction
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 
PURPOSE: To prospectively assess patient anxiety, understanding of the procedure being performed, perception of pain level, and satisfaction with medication given for a variety of diagnostic and therapeutic vascular and visceral (nonvascular) interventional procedures.

MATERIALS AND METHODS: The authors interviewed 204 patients before and after they underwent an interventional radiologic procedure. Patients responded to a series of questions by using a visual analog scale. Patients were grouped according to (a) their level of experience with the procedure and (b) the type of procedure performed (diagnostic or therapeutic visceral procedure or diagnostic or therapeutic vascular procedure).

RESULTS: Patients who had previous experience with a procedure, whether visceral or vascular, were less anxious, had more understanding, and anticipated less pain than did those who did not have experience with a procedure. Patients who had only local anesthesia for visceral biopsy experienced greater pain than did those who had both local and intravenous anesthesia. Satisfaction scores, however, were similar throughout all groups.

CONCLUSION: Patients have a moderate amount of anxiety about interventional procedures and anticipate some discomfort. Most patients have a high level of satisfaction despite the amount of pain they experience during the procedure. Patients experienced with a procedure tend to have a greater understanding of the procedure and less anxiety.

Index terms: Anesthesia • Interventional procedures


    Introduction
 TOP
 Abstract
 Introduction
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 
Conscious sedation is an accepted method of pain control during interventional procedures. To our knowledge, however, the effect of conscious sedation on the level of pain and anxiety experienced by patients during these procedures has never been evaluated. Although it is an accepted practice for radiologists to use conscious sedation during procedures, a wide variation exists among interventional radiologists with regard to the use of anesthesia (13). In addition, to our knowledge, the patient's perception of the effectiveness of conscious sedation has never been evaluated.

We performed this study to measure, before and after an interventional procedure, patients' anxiety levels, understanding of the procedure being performed, perception of pain, and satisfaction with the medication given.


    MATERIALS AND METHODS
 TOP
 Abstract
 Introduction
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 
All inpatients and outpatients who underwent interventional radiologic procedures during a 6-week period were asked to participate in the survey. Patients were excluded from the study if (a) they were younger than 18 years; (b) they had known hypersensitivity to lidocaine, midazolam, or fentanyl; (c) they had received a sedative or analgesic within 4 hours before the procedure; or (d) the procedure was performed with bedside equipment in the intensive care unit. A total of 204 patients who fit the selection criteria participated in our study. Approximately 30 patients (in addition to the 204) had undergone either diagnostic or therapeutic nonvascular interventional procedures at bedside; none of these patients were interviewed. Also, in addition to the 204 patients, approximately 5% of all patients who underwent visceral and vascular procedures were not interviewed because of the logistics of the study.

Only one author (S.B.) conducted the actual survey, and he was not able to interview all patients because procedures were performed in different patients simultaneously. The individual performing the interviews was not involved in any of the interventional procedures. The patients ranged in age from 21 to 90 years (average age, 59 years); 103 patients were men, and 101 were women. One hundred twenty-four patients were outpatients, and 80 were inpatients.

The visual analog scale (VAS) format was used to measure the subjective feelings of fear and anxiety. The VAS is a proved method of pain measurement and has been used extensively in the past 20 years, particularly among anesthesiologists (48). The design of a typical VAS format question is briefly described here. First, after agreeing to participate in the survey, a patient is given a form that contains a series of statements, each of which is followed by a horizontal line measuring 10 cm in length; the ends of the lines are labeled with extreme limits of a subjective response. For example, a line measuring patient anxiety before the procedure would have "not at all anxious" at the left end and "very anxious" at the right end. The patient would then place a mark along the horizontal line to convey the magnitude of his or her anxiety. A mark in the middle, for instance, would indicate that the patient is moderately anxious. To convert the data into quantitative data, a ruler is used to measure the distance from the left end of the line; this value would indicate the amount of anxiety the patient expressed relative to an integer scale from 0 to 10.

Table 1 lists the parameters assessed before and after the procedure, the questions about patient anxiety before the procedure (responses ranged from "not anxious" to "very anxious") and patient pain during the procedure (responses ranged from "none" to "severe") that the radiologists performing the procedures were asked, and the range of responses.


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TABLE 1. Patient Response Analysis
 
Survey interviews with patients took place at least 1/2 hour before the procedure. Postprocedural survey interviews were performed 2–4 hours after the procedure, before the patients were discharged to the hospital floor or home. These interviews took place just before discharge to ensure that the patient was able to comprehend the postprocedural questions. The study was approved by our institutional review board, and written informed consent was obtained from all patients.

Analysis of Data
Data acquired from the VAS-format questionnaires were converted to numeric data and to an integer scale score ranging from 0 to 10. Excel 5.0 (Microsoft, Redmond, Wash), Word 6.0.1 (Microsoft), SystatFPV.5.2.1 (SPSS, Chicago, Ill), and DeltaGraph 3.5 (SPSS) were used in conjunction with a Power Macintosh computer (Apple Computer, Cupertino, Calif) to analyze and plot the data. Data analysis was performed with the Student t test or the analogous nonparametric procedure (Wilcoxon test) where appropriate. The level of statistical significance was set at .05. The Tukey comparison test was used where appropriate.

The 204 patients were classified as either experienced (n = 95) or inexperienced (n = 109). Patients were classified as experienced if they had previously undergone the same type of procedure or a similar procedure. Thus, by definition, a patient who had previously undergone diagnostic aortography was considered to be experienced if he or she were undergoing pulmonary angiography. Similarly, if a patient had previously undergone diagnostic chest biopsy and was currently undergoing adrenal biopsy, he or she was considered to be experienced. We recognize, for example, that chest biopsy and adrenal biopsy are somewhat different; however, we defined these as being similar because in both, a small amount of tissue is removed with a needle, and to a patient, this is considered a similar procedure. Thus, by our definition, patients who had previously undergone insertion of a catheter that remained in place (eg, for abscess drainage) were considered to be experienced if they were undergoing a procedure for the placement of a chest tube. Patients were classified as inexperienced if they had never previously undergone an interventional radiologic procedure.

A visceral interventional procedure was defined as any nonvascular intervention (eg, biliary drainage, abscess drainage, bone or soft tissue biopsy). Eighty-seven patients underwent diagnostic biopsy and 40 underwent therapeutic catheter insertion. Of the 40 patients who underwent catheter insertion, 29 underwent abscess drainage and/or catheter insertion, eight underwent biliary and/or gallbladder drainage, and three underwent percutaneous nephrostomy.

The diagnostic vascular procedures performed consisted of either diagnostic aortography and runoffs (peripheral vascular studies) or pulmonary angiography (n = 67). The therapeutic vascular procedures consisted of either angioplasty (n = 7) or chemoembolization (n = 3).

We analyzed patient responses to the questions (Table 1) according to (a) patient experience and (b) the type of procedure performed—that is, vascular or visceral and diagnostic or therapeutic.

Analgesic and Anesthetic Sedation
All patients received a local skin anesthetic of 3–15 mL of 1% lidocaine. Depending on the procedure, patients had different levels of intravenous conscious sedation. For example, the patients who underwent biliary procedures routinely received more medication than did those who underwent biopsy. A patient who underwent a biliary drainage procedure might have received 4 mg of midazolam and 200 mg of fentanyl. A patient who underwent biopsy might have received only 1 mg of midazolam and 50–100 mg of fentanyl. The medication, however, was given by a small number of nurses (n = 7) with relatively homogeneous training in conscious sedation. One nurse induced conscious sedation for all the visceral cases, and four nurses induced sedation for the vascular cases. The amount and dose of medication were relatively consistent.

In general, the methods of and doses for sedation were uniform within the specific groups because they were given by a small group of nurses (n = 7) who followed similar guidelines. At our institution, the drugs used for conscious sedation are midazolam (Versed; Roche Laboratories, Nutley, NJ) and fentanyl (Sublimaze; Janssen Pharmaceutical, Piscataway, NJ). The standard initial dose is 14.5–43.5 µg/kg (1.0–3.0 mg per 70 kg) midazolam and 0.71–1.42 µg/kg (50–100 µg per 70 kg) fentanyl administered intravenously as a slow (30–60-second) bolus infusion for induction. Additional maintenance doses were given at 50% of the loading dose at 5-minute intervals.

All patients who underwent deep abdominal and retroperitoneal biopsy, nonvascular therapeutic, and diagnostic or therapeutic vascular procedures had intravenous conscious sedation. Only those patients who underwent superficial soft tissue, bone, or chest biopsy procedures (n = 44) had local anesthesia alone.


    RESULTS
 TOP
 Abstract
 Introduction
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 
Preprocedural Patient Assessment
Data analysis.—Inspection of the histograms of the VAS scores revealed that the responses did not appear to be normally distributed; as a result, the P values presented were derived by using the nonparametric Wilcoxon test rather than the Student t test. The VAS scores in Tables 24 are mean values rather than medians and ranged from 0 to 10 for all parameters.


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TABLE 2. Summary of Scores according to Level of Patient Experience
 

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TABLE 3. Summary of Preprocedural Scores according to Type of Procedure
 

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TABLE 4. Summary of Postprocedural Scores according to Type of Procedure
 
Level of anxiety.—Patients expressed a full range of anxiety levels before undergoing the procedure (Table 2). On average, the patients expressed a moderate level of anxiety (mean score, 4.1); the SD, however, was 2.9. More specifically, the experienced patients were less anxious (mean score, 3.4) than the inexperienced patients (mean score, 4.6). The Figure shows the preprocedural anxiety levels expressed by the experienced patients.



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Figure 1. Histogram of preprocedural anxiety levels expressed by experienced patients (n = 95).

 
There was no correlation between the type of procedure performed and the level of patient anxiety. For example, some patients who underwent complicated therapeutic procedures (eg, biliary drainage and cholecystostomy) had a lower anxiety level than did those who underwent what would be considered a less complicated diagnostic procedure (eg, computed tomography–guided chest or abdominal biopsy). There was no statistically significant difference in the anxiety levels between the diagnostic and therapeutic visceral subgroups (P = .34, Tukey test) (Table 3).

Level of understanding.—The experienced patients who had a history with or knowledge about the procedure had a significantly better (P < .001) understanding of the procedure than did the inexperienced patients (Table 2). The patients undergoing diagnostic or therapeutic vascular procedures had higher mean preprocedural levels of understanding (7.2 and 8.1, respectively). This again may be due to the fact that of the 76 patients undergoing a vascular procedure, 47 (62%) had previously undergone a similar procedure.

Anticipated level of pain.—On average, the experienced patients anticipated a low to moderate level of pain (mean score, 3.1), and the inexperienced patients anticipated a moderate level of pain (mean score, 4.7). This difference was statistically significant (P = .002) (Table 2). The difference in the anticipated level of pain between the two designated procedural groups (vascular and visceral) (Table 3) was not statistically significant. Patients who underwent diagnostic visceral procedures with conscious sedation, however, overestimated the amount of pain they experienced (P < .001).

Postprocedural Patient Assessment
Level of pain during procedure.—There was no statistically significant difference in the level of pain appreciated by the experienced and inexperienced groups (Tables 2 and 4). There was a statistically significant difference in pain experienced between the patients who underwent diagnostic biopsy (bone or chest) without conscious sedation and those who underwent biopsy (bone or chest) with conscious sedation. The mean pain score for patients who underwent bone or chest biopsy was 4.3. This was greater than the pain perceived by the patients who underwent vascular intervention (P = .02) or other types of nonvascular biopsy (P = .001).

The difference in the understanding of the procedure by any of the above-defined subgroups (eg, nonvascular vs vascular) was not statistically significant (P = .93) (Table 3).

Level of satisfaction with the medication provided during the procedure.—The experience level of a patient did not significantly affect the satisfaction rating. The experienced patients expressed the highest level of satisfaction (mean score, 8.39); the mean satisfaction score for inexperienced patients was 7.9 (P = .06) (Table 2). The amount of pain was shown to correlate with patient satisfaction (Pearson correlation, -0.50).

For patients who underwent nonvascular procedures, a variety of satisfaction scores were expressed. The subgroup of patients who underwent diagnostic nonvascular procedures (eg, bone, soft tissue, or chest biopsy) and had only local anesthesia tended to be less satisfied with their experience, reporting mean scores of 7.2–7.4 versus 8s and 9s in the previous group. Despite the lower satisfaction scores seen in this subgroup, the results of comparison analysis indicated that the mean satisfaction scores were not significantly different.


    DISCUSSION
 TOP
 Abstract
 Introduction
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 
Although the growth of interventional radiology has increased dramatically in the past 5–10 years, there has been very little documentation or study with regard to patient anxiety about a procedure, perception of pain, understanding of a procedure, or satisfaction with a procedure. We attempted to perform a prospective study of these issues in patients undergoing a wide range of interventional radiologic procedures.

To quantify the patients' responses to our questions in an objective manner, we used the VAS. With the VAS, patients are not asked to define subjective terms such as minimal, moderate, or extreme. Many investigators (5,6) have suggested that the VAS eliminates the examiner influence or bias that often comes with verbal questioning and is a more appealing method of evaluation for the participant. These scales have been successfully used in the evaluation of sedative and analgesic drug effects in patients (711) and in the evaluation of patients with joint pain due to various arthritides (6,9,12). Although this method is not perfect, it remains a common way to assess pain (8).

From the answers to the preprocedural questions, it was apparent that patients who had previously experienced a similar procedure were less anxious, had a greater understanding of the procedure, and anticipated less pain. Although this also might be what we would anticipate, it is interesting that this was proved in an objective study and provides valuable insight for a physician performing a procedure in these types of patients. And, as demonstrated with the answers and observations about anticipated pain, an understanding of the patient's perception may be helpful when discussing an upcoming procedure. This was particularly true among the patients who underwent vascular procedures in this study, 62% of whom had previously undergone a similar study, regardless of whether the procedure was diagnostic or therapeutic. Although not statistically significant, there was also a tendency for these scores to be consistent with regard to the amount of pain anticipated for a particular vascular procedure.

With regard to the types of procedures performed, all patients, whether they underwent a nonvascular or vascular procedure, overestimated their anticipated pain. In particular, the patients who underwent diagnostic nonvascular (visceral) procedures overestimated their anticipated pain significantly (P < .001). This may be due to the fact that many of these patients, unlike those who underwent vascular procedures, had not previously undergone the procedure. Thus, although some of the responses may seem intuitively obvious, in our experience they were not fully thought of by the interventionalist before performing the procedure. Understanding that the patient may be anticipating a great deal of pain should prompt the interventionalist to spend more time attempting to reduce the patient's fear of pain. Often the radiologist tends to dwell on the technical side of the procedure (ie, "the catheter will have to be irrigated once a day") rather than assess the patient's fears about pain (13,14).

The results of studies such as ours reinforce the need to reeducate interventional radiologists about patients' concerns. A similar conclusion was recently reached by White et al (15) in their study on understanding informed consent. They noted that the informed consent policy might be improved substantially by teaching patients to recite the procedural risks. Although we did not attempt to do this in our study, it can be extrapolated that more discussions with patients about their anxiety and anticipated pain could reduce both concerns.

The amount of pain our patients experienced showed a mild correlation with their satisfaction (Pearson correlation, -0.50); this means that the patients had greater satisfaction when they experienced less pain. Conversely, although the patients who had intravenous conscious sedation conveyed the lowest average pain score among all groups, this did not necessarily translate into significantly higher satisfaction scores. For example, there was a significant difference in the amount of satisfaction noted by the patients who underwent chest and bone biopsy and had local anesthesia alone and by those who underwent other types of procedures and had conscious sedation. Results of comparison testing indicated that the average degree of pain experienced during bone biopsy was significantly greater than that experienced by the patients who underwent both diagnostic and therapeutic vascular procedures and those who underwent visceral procedures and received conscious sedation. On the other hand, although patients who underwent abdominal and pelvic procedures (always with conscious sedation) tended to be more satisfied than those who underwent bone or chest procedures, the difference was not significant.

Some patients had a discrepancy between their measurements of pain and satisfaction and gave a relatively high satisfaction score in proportion to the actual pain they experienced during the procedure. These patients would say, "That's the best the doctor could do" or "I don't think the doctor could have done any better," implying that they had experienced great discomfort during the procedure but believed that the physician had done his or her best to alleviate the pain. Thus, the patients with high pain scores were not necessarily less satisfied than those who experienced no pain during the visceral nonvascular or vascular procedures.

In summary, the results of this study demonstrate the considerable anxiety patients have about undergoing interventional procedures and their anticipated level of pain. Physicians probably should not assume that what they consider to be an easy procedure is easy for the patients. Finally, satisfaction and pain are not necessarily correlative.


    Footnotes
 
Abbreviation: VAS = visual analog scale

Author contributions: Guarantor of integrity of entire study, P.R.M.; study concepts and design, P.R.M., J.A.K., M.J.L.; definition of intellectual content, P.R.M., J.A.K., M.J.L.; literature research, S.B.; clinical studies, P.R.M., J.A.K., M.J.L.; data acquisition, S.B.; data and statistical analyses, E.F.H.; manuscript preparation, P.R.M.; manuscript editing, J.A.K., M.J.L., P.R.M.; manuscript review, P.R.M., M.J.L., J.A.K., E.F.H.


    References
 TOP
 Abstract
 Introduction
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 

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  7. Flandry F, Hunt JP, Terry GC, Hughston JC. Analysis of subjective knee complaints using visual analog scales. Am J Sports Med 1991; 19:112-118.[Abstract/Free Full Text]
  8. Scott J, Huskisson EC. Graphic representation of pain. Pain 1976; 2:171-184.
  9. Callahan LF, Brooks RH, Summey JA, Pincus T. Quantitative pain assessment for routine care of rheumatoid arthritis patients, using a pain scale based on activities of daily living and a visual analog pain scale. Arthritis Rheum 1987; 30:630-636.[Medline]
  10. Francois T, Blanloeil Y, Pillet F, et al. Effect of interpleural administration of bupivacaine or lidocaine on pain and morphine requirement after esophagectomy with thoracotomy: a randomized, double-blind and controlled study. Anesth Analg 1995; 80:718-723.[Abstract]
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  13. Cragg AH, Smith TP, Berbaum KS, Nakagawa N. Randomized double-blind trial of midazolam/placebo and midazolam/fentanyl for sedation and analgesia in lower extremity angiography. AJR Am J Roentgenol 1991; 157:173-176.[Abstract/Free Full Text]
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