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n Feature Article Patient Anxiety, Pain, and Satisfaction With Image-Guided Needle Biopsy Casey Jo Humbyrd, MD; Emily K. Miller, BA; Richard L. Skolasky, PhD; Laura M. Fayad, MD; Frank J. Frassica, MD; Kristy L. Weber, MD abstract Image-guided percutaneous needle biopsy has become the preferred diagnostic modality for bone and soft tissue tumors. However, to the authors’ knowledge, the levels of patient anxiety, pain, and satisfaction before and after the procedure have not been studied. Sixty-five patients undergoing image-guided needle biopsy of a possible bone or soft tissue tumor were prospectively surveyed to quantify preprocedure and postprocedure levels of anxiety and pain and to determine demographic and clinical correlates of anxiety, pain, and satisfaction. Anxiety was measured with the Spielberger State-Trait Anxiety Inventory, pain was measured with a visual analog scale, and satisfaction was measured by patient willingness to repeat the procedure if necessary. Statistical analysis was performed with Student’s t test, Fisher’s exact test, and linear regression analysis. Compared with preprocedure values, trait anxiety (defined as the underlying level of anxiety, P<.0011), state anxiety (defined as the current level of situational anxiety, P<.001), and pain (P<.05) decreased significantly postprocedure. The relationship between changes in pain and state anxiety was significant (r=0.31, P=.014), whereas no relationship was seen between changes in pain and trait anxiety (r=0.13, P=.28). Patients who were somewhat satisfied with the procedure reported higher levels of postprocedure pain than those who were completely satisfied (5.24±2.19 cm vs 1.70±2.08 cm, respectively; P<.001). In other words, lower levels of experienced pain correlated with patient satisfaction. Older age was inversely correlated with postprocedure pain (r=0.41, P=.001), and there was a trend toward increasing dissatisfaction among younger patients. [Orthopedics. 2016; 39(2):e219-e224.] D uring the past 20 years, imageguided percutaneous needle biopsy has replaced open biopsy as the diagnostic standard of care for bone MARCH/APRIL 2016 | Volume 39 • Number 2 and soft tissue tumors at most major US cancer centers.1-3 Percutaneous biopsy is often preferred to open biopsy because of its lower cost, decreased scarring and healing time, safer anesthesia, and decreased risk of tumor plane violation.2,4-6 Although previous studies determined the diagnostic accuracy of percutaneous needle biopsy for bone and soft tissue tumors,1-3 no studies have analyzed patients’ anxiety before biopsy, pain experienced during the procedure, and willingness to undergo the procedure again. The goal of the current study was to quantify the degree of anxiety and pain immediately before and after percutaneous biopsy in patients with musculoskeletal tumors to improve counseling for patients who are choosing between open and percutaneous biopsy. Similar studies of patients in other disciplines after biopsy and surgical procedures showed a postprocedure decrease in anxiety and less The authors are from the Department of Orthopaedic Surgery and the Russell H. Morgan Department of Radiology and Radiological Sciences, The Johns Hopkins University, Baltimore, Maryland. The authors have no relevant financial relationships to disclose. Correspondence should be addressed to: Casey Jo Humbyrd, MD, Department of Orthopaedic Surgery, Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, 6th Fl, A Building, Baltimore, MD 21224 ([email protected]). Received: May 20, 2015; Accepted: July 8, 2015. doi: 10.3928/01477447-20160119-01 e219 n Feature Article Table 1 Correlation Between Preprocedure and Postprocedure Anxiety and Pain Scores r (P) Parameter Anticipated Pain Experienced Pain Preprocedure 0.19 (.11) 0.10 (.42) Postprocedure 0.16 (.20) 0.30 (.02) Trait anxiety State anxiety Preprocedure 0.36 (.004) 0.16 (.19) Postprocedure 0.29 (.02) 0.38 (.002) pain than expected.7-12 The study also investigated the increasing body of knowledge about the relationship between preoperative anxiety and experienced pain.12 Finally, survey data were compared with demographic and clinical characteristics to determine whether certain subsets of patients are more likely to experience greater pain or anxiety with percutaneous biopsy. The authors expected to find that state anxiety would be higher preprocedure than postprocedure, trait anxiety would be the same preprocedure and postprocedure, and anticipated pain and patient anxiety would correlate. They also expected to find an association between experienced pain and patient satisfaction. Materials and Methods Institutional review board approval was obtained in August 2009 and renewed annually. Patients were recruited from October 2009 through December 2012. All adult patients of the musculoskeletal oncology division at the authors’ institution who were referred for computed tomography–guided needle biopsy were invited to participate. Excluded from the study were minors, pregnant women, vulnerable populations (ie, prisoners), non–Englishspeaking individuals, and those who had undergone a previous percutaneous needle biopsy. All patients who agreed to take e220 the survey provided informed consent to participate in the study. Biopsies were performed by 1 of 3 attending radiologists (all with more than 10 years of experience performing biopsies), with assistance from a musculoskeletal radiology fellow. Patients had local analgesia with 1% lidocaine, and intravenous access was created for all patients preprocedure. When provided, systemic analgesia consisted of intravenous fentanyl and midazolam given in standard doses and titrated as needed. The 65 eligible patients who participated completed the preprocedure survey immediately before the biopsy and then completed the postprocedure survey before discharge from the recovery unit. Patient anxiety was evaluated with the Spielberger State-Trait Anxiety Inventory.13 State anxiety was measured by responses to 20 statements that reflect current anxiety about a specific situation, and trait anxiety was measured by responses to 20 statements that reflect general disposition to anxiety. Responses were scored on a scale of 1 to 4 points, and a composite score of between 20 and 80 points was calculated for state and trait anxiety separately, with higher scores reflecting higher anxiety. A visual analog scale was used to assess anticipated and experienced pain. This tool has been used extensively for patients undergoing biopsy.7,9,10,14,15 Fi- nally, patient satisfaction was determined postprocedure in terms of willingness to undergo another needle biopsy if it were medically necessary, a technique used in similar studies.7,10,14,16 The response options in the survey were: (1) “Yes, unconditionally,” which was designated as completely satisfied; (2) “Yes, but only with more pain medication/anesthesia,” which was designated as somewhat satisfied; and (3) “No,” which was designated as not satisfied. The following prospectively collected patient information was obtained from the institution’s musculoskeletal oncology database: demographic data (ie, age, sex); clinical factors (ie, history of previous cancer or musculoskeletal lesion, preprocedure use of narcotics for any reason, intravenous analgesia during the procedure); and final diagnosis (Table 1). This information was analyzed to identify relationships between the data and the survey results. One patient did not return for followup after an inconclusive biopsy that was suspicious but not definitive for lymphoma. This patient was lost to follow-up and was excluded from analysis of the effect of diagnosis. Only 1 patient was dissatisfied; exclusion of this patient’s data from the analysis of pain and anxiety did not change the results, and therefore the data were excluded only from the analysis of satisfaction. Five patients (2 completely satisfied, 2 somewhat satisfied, and 1 dissatisfied) had unknown analgesia and were excluded from the intravenous pain medication category. Statistical Analysis An a priori power analysis was performed to determine the minimum number of completed surveys required. The mean clinically significant difference in visual analog scale pain score between ratings separated by 30 minutes is 1.3 cm.17 Therefore, the study was powered to detect as significant a difference as 1.3 cm between preprocedure pain anticipa- Copyright © SLACK Incorporated n Feature Article tion and postprocedure pain assessment. Assuming a standard deviation of 3 cm, the study needed to include 56 completed surveys to achieve 80% power to detect this difference. A matched-pairs Student’s t test was used to compare visual analog scale and Spielberger State-Trait Anxiety Inventory scores before and after biopsy to determine whether pain expectations and state anxiety changed significantly. Linear regression modeling was used to examine the relationship between anxiety and pain scores. A Spearman correlation coefficient was used to describe the strength of the association between variables. The change in anxiety and pain from preprocedure to postprocedure was calculated by subtracting preprocedure values from postprocedure values. A negative value represented a decrease in anxiety. Spearman correlation coefficients were calculated to (1) compare the change in anxiety with the change in pain, (2) compare the relationship between preprocedure and postprocedure anxiety and preprocedure and postprocedure pain, and (3) evaluate whether there was a relationship between patient age and anxiety and pain. Fisher’s exact test was used to explore the relationship between discrete variables (eg, the number of men and women) and patient satisfaction by constructing a 2×2 contingency table. Significance was set at P<.05 for all analyses. Results Anxiety, Pain, and Satisfaction Compared with preprocedure values, trait anxiety, state anxiety, and pain decreased significantly postprocedure (34.02±8.48 vs 31.51±8.18, P<.0011; 37.95±12.95 vs 31.82±10.29, P<.001; 3.97±2.71 vs 2.21±2.45, P<.001, respectively). The relationship between the change in state anxiety and the change in pain was statistically significant (r=0.31, P=.014). No significant relationship was found between the change in trait anxiety MARCH/APRIL 2016 | Volume 39 • Number 2 Figure: Correlation between the change in state anxiety and the change in pain (r=0.31, P=.014). and the change in pain (r=0.13, P=.28) (Figure). Preprocedure trait anxiety in patients who were diagnosed with a malignancy was significantly higher than that in patients diagnosed with a benign process (36.26±9.08 vs 31.67±7.20, respectively; P=.03). Significant correlations were found between preprocedure state anxiety and anticipated pain and between postprocedure state and trait anxiety and experienced pain (Table 1). Of the patients, 54 (83.1%) were completely satisfied with the procedure and 10 (15.4%) were somewhat satisfied (Table 2). When the anxiety and pain scores of the 2 subsets of satisfied patients were compared, postprocedure pain was the only significant variable between those who were completely satisfied and those who were somewhat satisfied (1.70±2.08 vs 5.24±2.19, respectively; P<.001). Preprocedure and postprocedure anxiety scores for somewhat satisfied patients were higher than those for patients who were completely satisfied, but this increase was not statistically significant (Table 2). Demographic and Clinical Variables Half of the participants were women (31 of 65, 47.7%), and mean age was 53.34±16.77 years. One third of patients (21 of 65, 32.3%) were taking narcot- ics before the procedure, and most of the patients had no history of tumor (37 of 65, 56.9%). More bone biopsies than soft tissue biopsies were performed (37 vs 28). Of the biopsies, 17 (26.1%) were performed with local analgesia only, 43 (66.2%) were performed with local and systemic analgesia, and in 5 cases the use or nonuse of systemic sedation was not recorded. The final pathology report showed 30 benign tumors (46.2%), 34 malignant tumors (52.3%), and 1 unknown tumor (1.5%). No statistically significant differences were found between women and men in trait anxiety, state anxiety, pain score, or satisfaction before and after the procedure (Table 3). Patient age was inversely correlated with experienced pain (r=-0.41, P=.001) (Table 3). Patients who were somewhat satisfied tended to be younger than those who were completely satisfied, but the difference was not statistically significant (P=.065) (Table 2). Patients who took narcotic pain medication preprocedure for any reason had higher preprocedure trait anxiety than patients who did not (32.59±7.77 vs 37.00±9.30, respectively; P=.049) (Table 4). They were also less satisfied with the procedure (somewhat satisfied, 60%; completely satisfied, 29.6%), but this difference was not statistically significant (P=.08) (Table 2). e221 n Feature Article Table 2 Comparison of Anxiety, Pain, and Demographic and Clinical Characteristicsa in Completely Satisfied and Somewhat Satisfied Patientsb Completely Satisfied Patients (n=54) Somewhat Satisfied Patients (n=10) P Preprocedure 33.46 (8.30) 36.90 (9.69) .25 Postprocedure 30.78 (7.66) 35.90 (10.16) .07 Preprocedure 37.59 (13.42) 40.30 (11.07) .55 Postprocedure 30.94 (10.49) 37.10 (8.10) .08 Preprocedure 3.85 (2.79) 4.53 (2.44) .48 Postprocedure 1.70 (2.08) 5.24 (2.19) <.001 Men/women, No. 30/24 4/6 .49 Age, mean±SD, y Parameter Trait anxiety, mean (SD) State anxiety, mean (SD) Pain, mean (SD) Characteristic 54.91±16.36 44.20±17.61 .06 Taking/not taking preprocedure narcotics, No. 16/38 6/4 .08 With benign/malignant final diagnosis,c No. 26/28 4/6 .74 Using local only/intravenous pain medication,d No. 14/38 3/5 .68 Undergoing bone/soft tissue biopsy, No. 30/24 6/4 1.0 a Discrete variables were analyzed with Fisher’s exact test with a 2×2 contingency table. The continuous variable (age) was analyzed with an unpaired Student’s t test. The 1 dissatisfied patient (would refuse a second biopsy) was excluded from the analysis. Satisfied patients were those who stated that they would undergo the needle biopsy procedure again unconditionally; somewhat satisfied patients were those who stated that they would undergo the needle biopsy procedure again only with additional pain medication or anesthesia. b Completely satisfied patients were those who stated that they would undergo the needle biopsy procedure again unconditionally; somewhat satisfied patients were those who stated that they would undergo the needle biopsy procedure again only with additional pain medication or anesthesia. c One completely satisfied patient had no ultimate diagnosis made and was excluded from the final diagnosis row. d Five patients (2 completely satisfied, 2 somewhat satisfied, and 1 dissatisfied) had unknown analgesia and were excluded from the intravenous pain medication row. A final diagnosis of malignancy was associated with increased preprocedure trait anxiety (P=.03), preprocedure state anxiety, and postprocedure state anxiety (Table 4). No association was found between final diagnosis and pain or between final diagnosis and satisfaction. No difference in pain, anxiety, or satisfaction was found with the use of intravenous anal- e222 gesia (vs local only) or with biopsy type (bone vs soft tissue) (Table 2 and Table 4). Discussion This study analyzed patient anxiety, pain, and satisfaction with computed tomography–guided percutaneous needle biopsy used to diagnose bone and soft tissue tumors. To the authors’ knowledge, this is the first study of its kind, and the results provide baseline measures that can be used for clinical counseling and future research. The perceived pain experienced by patients was usually mild, the perceived pain associated with biopsy for bone tumors was similar to that for soft tissue tumors, and the perceived pain associated with biopsy performed with local analgesia alone was similar to that for biopsy performed with light sedation.2 As predicted, state anxiety was significantly higher preprocedure than postprocedure. Multiple correlations were found between anxiety and pain (Figure and Table 1). Although there is a growing body of knowledge about the relationship between preoperative anxiety and postoperative pain,3,11,13,14,18 neither preprocedure trait anxiety nor preprocedure state anxiety correlated with experienced pain in the current study (Table 1). One reason for this finding may be that, although the procedure itself may be painful, minimal pain occurs postprocedure. Therefore, this procedure likely differs from surgical procedures in which patients experience postoperative pain. Trait anxiety was expected to remain unchanged, but it was found to be higher preprocedure than postprocedure. The trait anxiety score (an individual’s general disposition to anxiety) is considered fixed, whereas the state anxiety score represents anxiety about the current situation.19 These data suggest that the process of undergoing a biopsy that might diagnose a life-threatening disease may be stressful enough to increase a patient’s trait anxiety. Interestingly, preprocedure trait anxiety in patients diagnosed with a malignancy was significantly higher than that in patients diagnosed with a benign lesion. Patients whose preprocedure evaluation suggested a malignant process often have been counseled about this possibility by their physicians, and this may explain the differential in baseline (preprocedure) but not postprocedure trait anxiety. Copyright © SLACK Incorporated n Feature Article The authors also hypothesized that there would be an association between experienced pain and patient satisfaction.19 Patients who were completely satisfied vs those who were somewhat satisfied had average pain levels of 1.70±2.08 cm and 5.24±2.19 cm, respectively (P<.001). Less satisfied patients had higher anxiety and anticipated pain scores, but only the difference in experienced pain was statistically significant. No association was found between patient sex and anxiety, pain, or satisfaction. However, the study found a negative correlation between age and postprocedure pain (r=-0.41, P=.001). Additionally, somewhat satisfied patients were an average of 10 years younger than completely satisfied patients (44.20±17.61 vs 54.91±16.36, respectively), although this difference was not statistically significant. The study was underpowered to evaluate this difference, and it is likely that a larger sample would show a statistically Table 3 Relationships of Demographic Variables to Anxiety and Pain Sex Age Women (n=31) Men (n=34) P r P Preprocedure 35 (8.61) 33.12 (8.38) .38 -0.017 .88 Postprocedure 32.35 (8.73) 30.74 (7.69) .43 -0.108 .38 Preprocedure 39.06 (12.65) 36.94 (13.31) .51 -0.046 .71 Postprocedure 33.87 (10.94) 29.94 (9.44) .13 0.001 .99 Preprocedure 4.57 (2.90) 3.42 (2.45) .09 -0.21 .10 Postprocedure 2.08 (2.69) 2.34 (2.24) .68 -0.41 .001 Parameter Trait anxiety, mean (SD) State anxiety, mean (SD) Pain, mean (SD) significant difference. The relationship between increased patient satisfaction and increased age has been well documented; it is not unique to the needle biopsy procedure.19,20 A possible explanation is that younger patients generally metabolize medications at a faster rate and may require a dosing nomogram different from the current standardized protocol, which does not vary by age.6 Another explanation is that, as a cohort, young patients have less exposure to medical and surgical Table 4 Relationship of Clinical Characteristics to Anxiety and Pain Trait Anxiety Parameter State Anxiety Pain Preprocedure Postprocedure Preprocedure Postprocedure Preprocedure Postprocedure Not taking (n=44), mean (SD) 32.59 (7.77) 30.61 (7.97) 36.64 (12.26) 31.05 (10.21) 4.02 (2.78) 2.48 (2.70) Taking (n=21), mean (SD) 37.00 (9.30) 33.38 (8.48) 40.71 (14.18) 33.43 (10.52) 3.87 (2.64) 1.67 (1.74) .04 .20 .24 .39 .84 .21 Benign (n=30), mean (SD) 31.67 (7.20) 29.97 (7.09) 34.70 (11.39) 29.23 (7.74) 3.84 (2.79) 2.35 (2.49) Malignant (n=34), mean (SD) 36.26 (9.08) 33.21 (8.74) 41.06 (13.77) 34.44 (11.64) 4.17 (2.66) 2.16 (2.46) .03 .11 .05 .04 .63 .77 Local only (n=17), mean (SD) 33.18 (7.70) 30.94 (8.05) 33.06 (12.83) 30.29 (10.87) 3.01 (2.52) 2.58 (2.98) Intravenous (n=43), mean (SD) 34.14 (8.33) 31.51 (7.69) 39.65 (12.97) 32.28 (10.25) 4.07 (2.75) 2.00 (2.16) .68 .80 .08 .51 .18 .41 Bone (n=37), mean (SD) 33.81 (8.74) 31.22 (8.01) 39.84 (13.18) 32.00 (10.36) 4.39 (2.59) 2.07 (2.21) Soft tissue (n=28), mean (SD) 34.29 (8.28) 31.89 (8.53) 35.46 (12.42) 31.57 (10.39) 3.42 (2.82) 2.41 (2.76) .83 .74 .18 .87 .16 .59 Preprocedure narcotics P Final diagnosis P Analgesia P Biopsy type P MARCH/APRIL 2016 | Volume 39 • Number 2 e223 n Feature Article interventions and therefore are surprised by the relative discomfort of the biopsy procedure. Conversely, older patients are more likely to have undergone invasive procedures and therefore may grade their pain experience relative to those procedures. Patients who had been taking narcotics preprocedure had higher anxiety scores than those who had not been taking them, but only the difference in preprocedure trait anxiety was statistically significant. Interestingly, anticipated and experienced pain were lower in patients who were taking preprocedure narcotics, although the difference was not statistically significant. Furthermore, patients taking narcotics preprocedure tended to be less satisfied with the biopsy experience, although this trend was not statistically significant. Orthopedic oncologists and radiologists should be aware that patients taking narcotics preprocedure have higher anxiety levels preprocedure, and they may wish to modify their clinical approach to address this increased anxiety and improve the patient experience. In addition, because of potential tolerance, patients taking narcotic pain medication at baseline may require a higher dose or an alternative dosing nomogram. Potential limitations of the study are the enrollment of patients from 3 different attending orthopedic surgeons with slightly different preprocedure patient counseling who underwent biopsy with 3 different musculoskeletal radiologists. To limit variability, the radiologists used a uniform consent form for the procedure. Additionally, the analgesia given to the cohort of patients varied. Intravenous analgesics were given by the nursing staff according to a standardized protocol based on reported and perceived patient discomfort as necessary. Many patients also were taking narcotic pain medication preprocedure, which may have affected the amount of analgesia given. Future studies could repeat the Spielberger State-Trait Anxiety Inventory e224 several days after the procedure to determine whether the downward trend in trait anxiety continues or if it increases as the patient switches the focus of anxiety from the procedure to the results. Also, studies could investigate whether patient anxiety, pain, and satisfaction are affected by the use of a preprocedure supplemental video,21 intraprocedure music,14 or intraprocedure patient-controlled or age-directed analgesia dosing. Conclusion This study presents the first evaluation of patient pain, anxiety, and satisfaction with needle biopsy. Clinicians can now counsel their patients about the relatively mild discomfort of the procedure, which may decrease preprocedure anxiety. Additionally, clinicians should consider individualized dosing regimens for younger patients and those taking narcotic pain medication. References 1. Ogilvie CM, Torbert JT, Finstein JL, Fox EJ, Lackman RD. Clinical utility of percutaneous biopsies of musculoskeletal tumors. Clin Orthop Relat Res. 2006; 450:95-100. 2. Skrzynski MC, Biermann JS, Montag A, Simon MA. Diagnostic accuracy and chargesavings of outpatient core needle biopsy compared with open biopsy of musculoskeletal tumors. J Bone Joint Surg Am. 1996; 78(5):644-649. 3. Yang J, Frassica FJ, Fayad L, Clark DP, Weber KL. Analysis of nondiagnostic results after image-guided needle biopsies of musculoskeletal lesions. Clin Orthop Relat Res. 2010; 468(11):3103-3111. 4. Fraser-Hill MA, Renfrew DL. Percutaneous needle biopsy of musculoskeletal lesions: 1. Effective accuracy and diagnostic utility. AJR Am J Roentgenol. 1992; 158(4):809812. 5. Logan PM, Connell DG, O’Connell JX, Munk PL, Janzen DL. Image-guided percutaneous biopsy of musculoskeletal tumors: an algorithm for selection of specific biopsy techniques. AJR Am J Roentgenol. 1996; 166(1):137-141. 6. Schweitzer ME, Gannon FH, Deely DM, O’Hara BJ, Juneja V. 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The analgesic efficacy of lidocaine/prilocaine (EMLA) cream during fine-needle aspiration biopsy of thyroid nodules. Clin Endocrinol (Oxf). 2007; 66(5):691-694. 18. Chau DL, Walker V, Pai L, Cho LM. Opiates and elderly: use and side effects. Clin Interv Aging. 2008; 3(2):273-278. 19. Hall JA, Dornan MC. Patient sociodemographic characteristics as predictors of satisfaction with medical care: a meta-analysis. Soc Sci Med. 1990; 30(7):811-818. 20. Thiedke CC. What do we really know about patient satisfaction? Fam Pract Manag. 2007; 14(1):33-36. 21. Luck A, Pearson S, Maddern G, Hewett P. Effects of video information on precolonoscopy anxiety and knowledge: a randomised trial. Lancet. 1999; 354(9195):2032-2035. Copyright © SLACK Incorporated