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A Novel Tool to Facilitate Communication of Pain Quality: “Pain Blocks”
Clinical Therapeutics/Volume xxx, Number xxx, xxxx
A Novel Tool to Facilitate Communication of Pain Quality: “Pain Blocks” Jason B. Hack, MD1; Gillian K. Melikian 2; Clare Jessey 3; and Janette Baird, PhD4 1
Alpert Medical School, Department of Emergency Medicine, Division of Medical Toxicology, Brown University and Rhode Island Hospital, Providence, RI, USA; 2Department of Emergency Medicine, Research, Rhode Island Hospital, Providence, RI, USA; 3Rhode Island School of Design, Providence, RI, USA; and 4Alpert Medical School, Department of Emergency Medicine, Research, Rhode Island Hospital, Providence, RI, USA ABSTRACT Purpose: Assessment of pain is difficult for many reasons, including the inability of patients to translate a subjective experience into words, and it is challenging for health care providers to create a shared understanding of what is being described. Physical representations exist to facilitate the objective scaling of “severity” or “intensity” of pain, but none exist to enable communication of pain quality. The objective of this proof-of-concept study was to develop, introduce, and evaluate consistency of participant interpretation of a novel kinesthetic tool set (Pain Blocks) that was designed to represent qualities of pain. Methods: A prospective convenience sampling of participants approached in nonmedical settings over 9 months was queried to assess 6 randomly ordered Pain Blocks during structured interviews. The subjects were directed to associate each Pain Block with a pain quality from a list of 12 suggestions or use a free-text area for “other” descriptors. During the study, Pain Blocks were removed and replaced based on consistency of response at interval assessments. In part 2, participants were asked if any of the Pain Blocks accurately characterized the quality of their last severe pain. Findings: A convenience sample of 220 participants was enrolled in the study and assessed 6 Pain Blocks. They interpreted and applied a pain quality to each of the blocks. Using interval assessments, a final selection of 6 Pain Blocks was derived that had consistent high association with specific pain qualities, either individually or with synonyms: Block 1 (stretching and tearing), 81.8%; Block 3 (crampy
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and throbbing), 90.4%; Block 4 (sharp and stabbing), 99.1%; Block 6 (crushing and dull), 94.1%; Block 7 (twisting), 95.8%; and Block 8b (burning), 100%. There were no differences in consistency of block interpretation between sexes or in terms of past experience of pain. Implications: We were able to create a group of physical objects (Pain Blocks) that were consistently and persistently interpreted, with a high degree of reliability, to represent specific pain qualities across ages and sexes. Although this proof-of-concept article was limited by the inclusion of English-speaking patients only and voluntary participants not currently in pain, the results support further investigation into tools to create a shared understanding of pain sensations between provider and participant. (Clin Ther. xxxx;xxx:xxx) © 2020 Elsevier Inc. All rights reserved. Key words: communication, novel, pain, proof of concept, quality, tool.
INTRODUCTION The ability to obtain an accurate history is critical to medical diagnosis. The capacity of some patients to provide a history is limited for a variety of reasons, including the ability of the practitioner to obtain it.1e4 Pain is a common presenting report among those seeking medical care, with some studies
Accepted for publication December 28, 2019 https://doi.org/10.1016/j.clinthera.2019.12.013 0149-2918/$ - see front matter © 2020 Elsevier Inc. All rights reserved.
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Clinical Therapeutics reporting that 42% of emergency department visits are pain related.5e9 Objectively categorizing pain experience is difficult.10e13 Pain has been defined as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.“14 Because pain is a subjective, emotionally related experience, the description of it is determined by the individual's life experiences and ability to communicate.12,15 Difficulty or incomplete ability to effectively communicate this sensation to a health care provider has been recognized and investigated by using novel means, with the goal of potentially narrowing any communication gap that might adversely affect pain management and other medical care.10e15 Previous research into pain assessment initially places pain into a binary formatdabsent or present.13 An attempt is then made with the latter population to quantify the “amount,” “severity,” or “intensity” of the discomfort. These include the application of descriptive subjective quantification tools, such as a visual analog scale,16 Faces Pain Scale,17 or numerical “pain scales,“18 and objective scores, such as an “erythema index.“19 Exploration into the objective understanding of individuals’ verbal expression of pain has also highlighted shortcomings of current tools, especially in specific populations. The development of tools that verbally evaluate pain (including the McGill Pain Questionnaire10,20,21) or cause pain with electric shocks for comparison (Tursky Pain Perception Profile13) have met with variable success for a number of reasons.21 Efforts to assess pediatric pain also revealed the need for improvement of current tools.22 Attempts have been made to examine tangible representations of pain to objectively quantify it. Examining the creative artwork of both adults and children in pain and assessment of their verbal responses have met with varied success.23e25 In addition, elderly patients may have significant difficulties when attempting to convey pain experiences, which may result from significant medical illnesses or cognitive limitations15,26,27 common in this population. The objective of the present proof-of-concept study was to introduce and evaluate a new novel kinesthetic tool set (Pain Blocks) that was developed as an additional means of bridging this
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communication gap between patients and providers to achieve a better understanding of discomfort.
MATERIALS AND METHODS Study Design This observational, proof-of-concept study was conducted over 9 months (September 2018eMay 2019) with a convenience sample of participants (who were not patients) recruited from both a hospital campus and off-campus areas. The institutional review board at the study site approved the study protocol.
Materials The Pain Blocks are objects that were conceptualized, designed, and fabricated by using various methods, from traditional hand-making to computer-aided design and three-dimensional printing (Fig. 1). The blocks used a common design language; these unifying characteristics included being similarly sized and made of durable, cleanable, modeling material (plastic) of uniform color. These objects were sized to be held in the hand (generally 8-cm spheres with some irregularity); we prioritized their form, contour, and visual clues to distinguish each block, without attempting to elicit discomfort when held. By controlling these variables, more feedback could be elicited on impression and interpretation without interposing the variability of sensation.
Participants Participants were eligible for study inclusion if they were aged 8 years, cognitively able to give consent, competent in English, and had no physical impairment that would affect their ability to evaluate the Pain Blocks. “Non-patient” individuals were approached by the trained research assistant and asked to agree to participate in the study primarily on the hospital campus. Fig. 2 displays the flow of participants into the study. Consented participants were given both written and verbal explanations of the study via a standard script. Their age range, sex, and highest level of schooling completed were recorded. For participants aged <18 years, parental consent and child assent were obtained.
Data Acquisition Once the participants consented to undertake the study, they were read a structured script that
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Individuals approached N = 357
1
2
6
Refused N = 136
Study participants N = 220
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Figure 2.
3
8a
Did not speak english N=1
Participant flow.
closely resembles the Quality of the pain you had?” and asked to choose the Pain Block that you think represents the Quality of the pain you had.
Block Selection and Interval Analysis 4
8b
5
Figure 1.
Examples of pain blocks.
described the study and what they would be doing. Researchers were given limited ad hoc leeway to further describe the study as needed; otherwise, they were trained to use study descriptors only. Our written script for participant instructions included: (1) You (or your child) will be offered the Pain Blocks one at a time and given some time to become familiar with the object. Then, you will be asked to choose which pain Quality, from a list, that you think each block is supposed to represent. (2) You (or your child) will be asked to recall the last bad pain you had, how long ago it was, and what it was from (eg, migraine, toothache, stomach ache, kidney stone, etc). You will be asked, “Which block most
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At initiation of the study, 6 Pain Blocks were selected from a group of 15 based on informal preliminary discussions with impartial college-level design students. These students were queried about which blocks they thought had a high likelihood of consistent interpretation. These 6 blocks were presented to the first 50 participants, and an interval analysis was performed for consistency of interpretation. Blocks 2 and 5 were found to have significant inconsistency and were removed from the study. Blocks 7 and 8a were added to the study set. Block 8a was found to have construction issues and was replaced by Block 8b after 20 assessments.
Procedure Part 1 Participants examined 6 Pain Blocks, presented individually. With each Pain Block presented, the subjects were directed to choose from a preprinted list of 12 pain descriptor options (derived from prior research16) with an additional free-text area for “other” (Appendix 1 provides a list of provided pain descriptors). For each block, participants had a new list of the same 12 pain qualities to choose from. To randomize the order of presentation, the Pain Blocks
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Clinical Therapeutics were kept in a covered box; they were selected by the researcher and placed in front of the participant in a blinded manner until all 6 blocks were presented. At the conclusion of the study, the blocks were placed back in the empty box. For each Pain Block, subjects were given a 1- to 2-min period to familiarize themselves with the object, and they were then directed to choose one pain quality descriptor they thought the Pain Block represented. They did so either by circling one of the descriptor quality terms from the list or filled in the “other” free text option. The sequence of Pain Block presentation was randomly ordered for each participant.
Part 2 After completion of part 1, participants were asked a series of scripted questions about a personal experience of pain. Participants were asked to “recall a recent severe pain” they had experienced, “what was it from?“, “how long ago?“, and “how bad was the pain on a scale of 1e10?” Participants were then asked if the quality of their painful experience was accurately represented by any of the presented Pain Blocks they had just been shown (“Do any of these Pain Blocks remind you of the pain you had? If so, which one?“).
Data Analysis Patient data were collected initially on paper surveys and later transcribed and managed by using Research Electronic Data Capture (REDCap).28 Data were also stored in Microsoft Excel (Microsoft Corporation, Redmond, Washington) and imported into SAS version 9.4 (SAS Institute, Inc, Cary, NC) for analysis. Descriptive data, frequencies, and percentages were first computed to assess the range of responses of the pain descriptors for each block. There were several rounds of block design presentation to participants, as described earlier. At each interval assessment, a criterion was set for a minimum consistency of at least 50% of participants associating a Pain Block with a specific quality descriptor. Pain Blocks that did not attain 50% agreement were eliminated and replaced. Subsequent analysis examined the frequency of top reported pairs of quality descriptors (often synonyms) with individual Pain Blocks (eg, “sharp” and “stabbing” or “stretching” and “tearing”).
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After the identification of Pain Blocks with the pain quality descriptor or descriptor synonym pairs, sensitivity analysis was conducted to determine if the pain descriptor with block matching was consistent between sexes. For each round of presentation, these data were calculated as percentages, and a series of c2 tests were conducted. Additional analysis was conducted to determine if experience with past pain (assessed on a 10-point scale, with 10 ¼ worst ever pain) altered the association of the block with the pain quality descriptor. The pain scores were ranked into pain quartiles to conduct this analysis. A Mantel-Haenszel c2 test of trend was conducted to evaluate the effect of increasing pain quartile on the frequency of pain descriptor selection.
RESULTS Participants In total, 357 people were approached, and 220 English-speaking non-patient participants consented and completed the study. Refusals occurred in 137 people approached; reasons for refusal to participate included “not having time” and “not interested.” Those 220 participants who completed the study each evaluated 6 individual Pain Blocks over 4 rounds of testing. Participant ages ranged from 8 to 79 years, with 50% of participants aged between 18 and 29 years; 4 (1.8%) were aged 17 years, and 5 participants were aged between 60 and 79 years (2.3%). The remaining 62 (45.9%) participants were between 30 and 59 years of age. Most participants were female (72%).
Testing Table I shows the number of participants exposed to each of the 9 blocks in each round of testing. Blocks 1, 3, 4, and 6 consistently attained an agreement rating of at least 50% on one of the pain quality descriptors at each interval assessment and were shown to all 220 participants. Block 7 had consistent interval assessment and was shown to 120 participants; Block 8a revealed an unanticipated construction failure after 20 assessments, and was replaced by Block 8b, which was shown to an additional 100 participations. Table II shows the number and percentage of the most frequent quality responses of participants for each block across the entirety of the study (Fig. 1 provides examples of the pain blocks). The criterion
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Table I.
Pain Blocks presented at each testing round.
Pain Block No.
Testing Round 1 (n ¼ 50)
Testing Round 2 (n ¼ 50)
Testing Round 3 (n ¼ 20)
Testing Round 4 (n ¼ 100)
1 2 3 4 5 6 7 8a 8b
X X X X X X
X
X
X
X X
X X
X X
X
X X X
X X X
No. Of Participants Shown Each Block 220 50 220 220 50 220 120 20 100
X ¼ administered.
of a minimum of 50% agreement of one descriptor for each individual block was not reached in the first round of testing for Blocks 2 and 5. Replacement Block 7 reached the agreement rate. Block 8a was replaced by Block 8b, which did attain the pre-set agreement rate. Table II also shows the top 2 most frequent pain quality descriptors attributed to the blocks. When synonyms are paired, the agreement rate for Block 1 (stretching and tearing) attained 81.8% agreement, Block 3 (crampy and throbbing) 90.4% agreement, Block 4 (sharp and stabbing) 99.1%, Block 6 (crushing and dull) 94.1%, Block 7 (twisting) 95.8%, and Block 8b (burning) 100%.
Sensitivity Analysis To determine the fidelity of pain descriptor selected, an analysis was conducted to assess the effects of sex and reporting of past pain independently. For sex, there was no significant difference in the selection of pain descriptor(s) between male and female subjects: for Block 1, c2 (2) ¼ 10.8, p ¼ 0.21; Block 3, c2 (2) ¼ 8.5, p ¼ 0.39; Block 4, c2 (2) ¼ 0.85, p ¼ 0.89; Block 6, c2 (2) ¼ 11.1, p ¼ 0.20; Block 7, c2 (2) ¼ 5.25, p ¼ 0.09; and Block 8b, c2 (2) ¼ 0.82, p ¼ 0.95. Table III shows the results for the Pain Blocks (1, 3, 4, 6, 7, and 8b) that attained the pre-set criterion of consistency in agreement of descriptor across the reported personal experience of past pain. We categorized the study participants’ response to their
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ratings of a prior painful experience according to their quartile of reported prior most painful experience on their responses to the 10-point scale (intensity scores for each pain quartile are also shown in Table III). To determine if frequency of selection of pain descriptor varied according to the intensity of past pain experience, we compared the frequency of selection of the most common identifier for each Pain Block (Table II) across the past pain experience quartiles. Across the quartiles of past pain experience, there was consistency in the proportion of participants selecting the quality for each block, with the exception for Block 6. Block 6 (describing crushing and dull pain) showed a significant trend for an increasing frequency for identifying this descriptor with the increase in pain quartile (c2 [24] ¼ 42.2; p ¼ 0.01).
DISCUSSION Previous literature supports the use of specific words and phrases to describe pain. In 1971, Melzack and Torgerson12 codified verbal characterization of pain into sensory, affective, and evaluative. They further divided the sensory experience into temporal, spatial, punctate pressure, incisive pressure, constrictive pressure, traction, thermal, brightness, and dullness. They found that converting the experience of pain into these verbal descriptors could be performed in a fairly reliable way, and they also reported a high level of agreement on particular dimensions of pain,
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6 Table II.
Allocation of top pain descriptors across all testing rounds. Values are given as number (%) unless otherwise indicated.
Descriptor Burning Crampy Crushing Dull Electric shock Hot Sharp Stabbing Stretching Tearing Throbbing Twisting Final descriptor choice
Block 1 (n ¼ 220) 0 0
Block 2 (n ¼ 50) 2 (4) 8 (16)
Block 3 (n ¼ 220)
8 (3.6) 142 (64.5) 1 (0.45) 0 2 (0.9) 22 (10) 12 (24) 7 (3.2) 1 (0.45) 0 0 3 (1.36) 1 (2) 0 5 (2.3) 0 1 (0.45) 0 2 (4) 0 26 (11.8) 4 (8) 1 (0.45) 154 (70) 0 0 1 (0.45) 8 (16) 57 (25.9) 7 (3.18) 14 (28) 2 (0.9) Stretching and Removed after Crampy and tearing (81.8%) round 1 throbbing (90.4%)
Block 4 (n ¼ 220)
Block 5 (n ¼ 50)
0 0 0 0
1 2 3 20 1 10
1 (0.45) 0 112 (50.9) 106 (48.2) 0 1 (0.45) 0 0 Sharp and stabbing (99.1%)
(2) (4) (6) (40) (2) (20)
Block 6 (n ¼ 220) 0
Block 7 (n ¼ 120)
7 (35)
Block 8b (n ¼ 100)
100 (100) 0 0 0 0 0 2 (0.9) 13 (65) 0 0 1 (0.45) 0 0 0 0 (0.9) 0 0 5 (10) 1 (0.45) 5 (4.2) 0 0 0 1 (0.45) 0 0 0 4 (8) 4 (1.8) 0 0 0 4 (8) 0 115 (95.8) 0 0 Removed Crushing and Twisting Removed Burning after round 1 dull (94.1%) (95.8%) after round 3 (100%) 4 (1.8) 168 (76.4) 39 (17.7)
0 0 0 0 0 0 0 0
Block 8a (n ¼ 20) 0 0 0 0
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Table III.
Pain descriptor selection according to quartile of prior pain experience intensity. Values are given as no (%).
Pain Block/Descriptor
Block 1: stretching and tearing Block 3: crampy and throbbing Block 4: sharp and stabbing Block 6: crushing and dull Block 7: twisting* Block 8b: burningy
Quartile 1: Quartile 2: Quartile 3: Quartile 4: Pain Score Pain Score Pain Score Pain Score 2e4 (n ¼ 62) 5 (n ¼ 56) 6e7 (n ¼ 48) 8e10 (n ¼ 54)
Statistic
53 (85.8)
46 (82.1)
40 (83.3)
37 (64.8)
c2 (24) ¼ 28.4, p ¼ 0.24
56 (90.3)
42 (75)
42 (87.5)
41 (75.9)
c2 (24) ¼ 25.4, p ¼ 0.39
62 (100)
56 (100)
47 (97.8)
53 (98.2)
c2 (9) ¼ 9.3, p ¼ 0.41
62 (100)
55 (88.3)
47 (87.9)
42 (77.8)
c2 (24) ¼ 42.2, p ¼ 0.01
37 (95.1) 32 (98.3)
34 (98.4) 28 (100)
22 (97.8) 19 (100)
22 (100) 20 (100)
c2 (6) ¼ 11.1, p ¼ 0.09 c2 (6) ¼ 6.4, p ¼ 0.38
1, n ¼ 40; quartile 2, n ¼ 35, quartile 3, n ¼ 23; and quartile 4, n ¼ 22. Quartile 1, n ¼ 33; quartile 2, n ¼ 28, quartile 3, n ¼ 19; and quartile 4, n ¼ 20.
* Quartile y
even among those with diverse backgrounds. Additional research has supported verbal cues as helping to communicate the experience of discomfort in a medical setting.10,11,12,20 Although language is useful for communication of pain qualities between patients and providers in many circumstances, it still relies on a multi-step process of interpretation and understanding that can interfere with the accurate transfer of information. Patients must have both the language skills and the ability to characterize their experience of an ephemeral sensation into words. The words must then be interpreted by the listener. In addition, all of these steps are shaded by the participants’ emotional and physiological experience with nociception. For example, some people are unable to express their pain beyond the term “bad” when describing the quality of their severe pain. Others may use a descriptive quality term; for example “sharp,” intending the word to represent one of several concepts, including “poke,” “severe,” “cutting,” or “acute.” The present proof-of-concept study showed that individuals from different age groups, sex, and educational backgrounds were able to quickly familiarize themselves, with minimum instruction, with abstract hand-held objects and understand that
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they represent physical manifestations of a variety of pain qualities. With intentional design, careful selection, and interval testing, we were able to create 6 Pain Blocks that were consistently interpreted by naive participants to represent specific qualities of pain. We were also able to show persistence of participants' interpretation of the Pain Blocks. This was shown by having participants reflect back on a recent significant somatic pain experience, recall the experience's pain quality, and then chose which of the Pain Blocks they felt most closely represented the quality of that personal prior experience of pain. For the duration of the interview period (10e15 min), participants consistently used the same terms they had just applied to the Pain Blocks without prompting. This spanned the interval between part 1 and part 2. Our findings suggest that the interposition of a physical object into the exchange of verbal information about the patient's sensation of pain might provide a tangible haptic reference point that both participants can use to establish a shared understanding. This approach offers the potential to address problems in communicating pain symptoms across a wide array of patient populations, especially given the consistency of response across sex, age, and level of prior painful experience.
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Clinical Therapeutics There are limitations to our study design that must be considered when interpreting these results. This was a convenience sample of participants who were not in pain during their study involvement and therefore may not have provided data that could be applied to a population in acute pain. Participants were eligible only if they were competent in understanding and communicating in English; we therefore do not know if the pain descriptors applied to each block would be consistent across different languages and cultural experiences. More research is needed to test this potentially useful diagnostic tool in patient populations in which communication might be challenging, such as with young children or people with cognitive impairments (including those with psychomotor limitations).
CONCLUSIONS To our knowledge, this proof-of-concept study is the first to develop and evaluate a set of uniquely designed physical representations of pain qualities with the ultimate intent of improving shared understanding and communication of the experience of pain. We were able to show that naive participants quickly understood and associated each of the Pain Blocks with a specific quality of pain with high consistency. With the results of this preliminary research, additional studies are being designed to explore the utility and applicability of the Pain Blocks in more defined groups. Planned future work involves testing of the tool in focus groups, including: patients concurrently in pain from specific types of discomfort (eg, dental pain, renal colic); patients in specific age categories (eg, young children, elderly); and also to see whether the Pain Blocks can act as a tangible foci, to create a shared understanding between patients and health care providers in communicationlimited populations.
CONFLICTS OF INTEREST The authors have indicated that they have no conflicts of interest regarding the content of this article.
ACKNOWLEDGMENTS The authors acknowledge and thank the following people for their contributions: Erin Ryan, Zach Ricca, and Susan Park.
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Dr. Hack was responsible for conceptualization, study design, data curation, investigation, methodology, project administration, resources, supervision, validation, visualization, writing of the original draft, and reviewing and editing the manuscript. Gillian Melikian was responsible for data curation, investigation, and writing of the original draft. Clare Jessey was responsible for conceptualization, methodology, resources, visualization, and writing of the original draft. Dr. Baird was responsible for conceptualization, formal analysis, investigation, methodology, project administration, software, validation, writing of the original draft, and reviewing and editing the manuscript.
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J.B. Hack et al. 9. Johnston CC, Gagnon AJ, Fullerton L, et al. One-week survey of pain intensity on admission to and discharge from the emergency department: a pilot study. J Emerg Med. 1998;16:377e382. 10. Melzack R. The McGill pain Questionnaire. Anesthesiology. 2005;103:199e202. 11. Melzack R. The perception of pain. Sci Am. 1961;204:41e49. 12. Melzack R, Torgerson WS. On the language of pain. Anesthesiology. 1971;34:50e59. 13. Tursky B, Jamner LD, Friedman R. The pain perception profile: a psychophysical approach to the assessment of pain report. Behav Ther. 1982;13:376e394. 14. International Association for the Study of Pain. International Association for the Study of Pain (IASP) Terminology. International Association for the Study of Pain; 2017. https://www. iasp-pain.org/terminology? navItemNumber¼576. Accessed April , 2019. 15. Tapp D, Chenacher S, Gerard NPA, et al. Observational pain assessment instruments for use with nonverbal patients at the end-of-life: a systematic review. J Palliat Care. 2019;34(4):255e266. https:// doi.org/10.1177/ 0825859718816073, 825859718816073 [Epub ahead of print]. 16. Joyce CR, Zutshi DW, Hrubes V, Mason RM. Comparison of fixed interval and visual analogue scales for rating chronic pain. Eur J Clin Pharmacol. 1975;8:415e420. 17. Hicks CL, von Baeyer CL, Spafford P, van Korlaar I, Goodenough B. The Faces Pain ScaleeRevised: toward a common metric in pediatric pain measurement. Pain. 2001;93:173 e183. 18. Tsze DS, von Baeyer CL, Pahalyants V, Dayan PS. Validity and
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Address for correspondence: Jason B. Hack, MD, 55 Claverick St, Providence, RI, 02903, USA. E-mail: [email protected]
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APPENDIX
Table S1. Participant Data Collection Sheet: For each of the Pain Blocks you will be handed, please complete the following assessment I think that the Pain Block ## is meant to represent this Quality of pain: “sharp” “dull” “stabbing” “burning” “crushing” “throbbing” “twisting” “electric shocks” “stretching” “crampy” “tearing” “hot” (Other)
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A Novel Tool to Facilitate Communication of Pain Quality: “Pain Blocks” Jason B. Hack, MD1; Gillian K. Melikian 2; Clare Jessey 3; and Janette Baird, PhD4 1
Alpert Medical School, Department of Emergency Medicine, Division of Medical Toxicology, Brown University and Rhode Island Hospital, Providence, RI, USA; 2Department of Emergency Medicine, Research, Rhode Island Hospital, Providence, RI, USA; 3Rhode Island School of Design, Providence, RI, USA; and 4Alpert Medical School, Department of Emergency Medicine, Research, Rhode Island Hospital, Providence, RI, USA ABSTRACT Purpose: Assessment of pain is difficult for many reasons, including the inability of patients to translate a subjective experience into words, and it is challenging for health care providers to create a shared understanding of what is being described. Physical representations exist to facilitate the objective scaling of “severity” or “intensity” of pain, but none exist to enable communication of pain quality. The objective of this proof-of-concept study was to develop, introduce, and evaluate consistency of participant interpretation of a novel kinesthetic tool set (Pain Blocks) that was designed to represent qualities of pain. Methods: A prospective convenience sampling of participants approached in nonmedical settings over 9 months was queried to assess 6 randomly ordered Pain Blocks during structured interviews. The subjects were directed to associate each Pain Block with a pain quality from a list of 12 suggestions or use a free-text area for “other” descriptors. During the study, Pain Blocks were removed and replaced based on consistency of response at interval assessments. In part 2, participants were asked if any of the Pain Blocks accurately characterized the quality of their last severe pain. Findings: A convenience sample of 220 participants was enrolled in the study and assessed 6 Pain Blocks. They interpreted and applied a pain quality to each of the blocks. Using interval assessments, a final selection of 6 Pain Blocks was derived that had consistent high association with specific pain qualities, either individually or with synonyms: Block 1 (stretching and tearing), 81.8%; Block 3 (crampy
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and throbbing), 90.4%; Block 4 (sharp and stabbing), 99.1%; Block 6 (crushing and dull), 94.1%; Block 7 (twisting), 95.8%; and Block 8b (burning), 100%. There were no differences in consistency of block interpretation between sexes or in terms of past experience of pain. Implications: We were able to create a group of physical objects (Pain Blocks) that were consistently and persistently interpreted, with a high degree of reliability, to represent specific pain qualities across ages and sexes. Although this proof-of-concept article was limited by the inclusion of English-speaking patients only and voluntary participants not currently in pain, the results support further investigation into tools to create a shared understanding of pain sensations between provider and participant. (Clin Ther. xxxx;xxx:xxx) © 2020 Elsevier Inc. All rights reserved. Key words: communication, novel, pain, proof of concept, quality, tool.
INTRODUCTION The ability to obtain an accurate history is critical to medical diagnosis. The capacity of some patients to provide a history is limited for a variety of reasons, including the ability of the practitioner to obtain it.1e4 Pain is a common presenting report among those seeking medical care, with some studies
Accepted for publication December 28, 2019 https://doi.org/10.1016/j.clinthera.2019.12.013 0149-2918/$ - see front matter © 2020 Elsevier Inc. All rights reserved.
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Clinical Therapeutics reporting that 42% of emergency department visits are pain related.5e9 Objectively categorizing pain experience is difficult.10e13 Pain has been defined as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.“14 Because pain is a subjective, emotionally related experience, the description of it is determined by the individual's life experiences and ability to communicate.12,15 Difficulty or incomplete ability to effectively communicate this sensation to a health care provider has been recognized and investigated by using novel means, with the goal of potentially narrowing any communication gap that might adversely affect pain management and other medical care.10e15 Previous research into pain assessment initially places pain into a binary formatdabsent or present.13 An attempt is then made with the latter population to quantify the “amount,” “severity,” or “intensity” of the discomfort. These include the application of descriptive subjective quantification tools, such as a visual analog scale,16 Faces Pain Scale,17 or numerical “pain scales,“18 and objective scores, such as an “erythema index.“19 Exploration into the objective understanding of individuals’ verbal expression of pain has also highlighted shortcomings of current tools, especially in specific populations. The development of tools that verbally evaluate pain (including the McGill Pain Questionnaire10,20,21) or cause pain with electric shocks for comparison (Tursky Pain Perception Profile13) have met with variable success for a number of reasons.21 Efforts to assess pediatric pain also revealed the need for improvement of current tools.22 Attempts have been made to examine tangible representations of pain to objectively quantify it. Examining the creative artwork of both adults and children in pain and assessment of their verbal responses have met with varied success.23e25 In addition, elderly patients may have significant difficulties when attempting to convey pain experiences, which may result from significant medical illnesses or cognitive limitations15,26,27 common in this population. The objective of the present proof-of-concept study was to introduce and evaluate a new novel kinesthetic tool set (Pain Blocks) that was developed as an additional means of bridging this
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communication gap between patients and providers to achieve a better understanding of discomfort.
MATERIALS AND METHODS Study Design This observational, proof-of-concept study was conducted over 9 months (September 2018eMay 2019) with a convenience sample of participants (who were not patients) recruited from both a hospital campus and off-campus areas. The institutional review board at the study site approved the study protocol.
Materials The Pain Blocks are objects that were conceptualized, designed, and fabricated by using various methods, from traditional hand-making to computer-aided design and three-dimensional printing (Fig. 1). The blocks used a common design language; these unifying characteristics included being similarly sized and made of durable, cleanable, modeling material (plastic) of uniform color. These objects were sized to be held in the hand (generally 8-cm spheres with some irregularity); we prioritized their form, contour, and visual clues to distinguish each block, without attempting to elicit discomfort when held. By controlling these variables, more feedback could be elicited on impression and interpretation without interposing the variability of sensation.
Participants Participants were eligible for study inclusion if they were aged 8 years, cognitively able to give consent, competent in English, and had no physical impairment that would affect their ability to evaluate the Pain Blocks. “Non-patient” individuals were approached by the trained research assistant and asked to agree to participate in the study primarily on the hospital campus. Fig. 2 displays the flow of participants into the study. Consented participants were given both written and verbal explanations of the study via a standard script. Their age range, sex, and highest level of schooling completed were recorded. For participants aged <18 years, parental consent and child assent were obtained.
Data Acquisition Once the participants consented to undertake the study, they were read a structured script that
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Individuals approached N = 357
1
2
6
Refused N = 136
Study participants N = 220
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Figure 2.
3
8a
Did not speak english N=1
Participant flow.
closely resembles the Quality of the pain you had?” and asked to choose the Pain Block that you think represents the Quality of the pain you had.
Block Selection and Interval Analysis 4
8b
5
Figure 1.
Examples of pain blocks.
described the study and what they would be doing. Researchers were given limited ad hoc leeway to further describe the study as needed; otherwise, they were trained to use study descriptors only. Our written script for participant instructions included: (1) You (or your child) will be offered the Pain Blocks one at a time and given some time to become familiar with the object. Then, you will be asked to choose which pain Quality, from a list, that you think each block is supposed to represent. (2) You (or your child) will be asked to recall the last bad pain you had, how long ago it was, and what it was from (eg, migraine, toothache, stomach ache, kidney stone, etc). You will be asked, “Which block most
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At initiation of the study, 6 Pain Blocks were selected from a group of 15 based on informal preliminary discussions with impartial college-level design students. These students were queried about which blocks they thought had a high likelihood of consistent interpretation. These 6 blocks were presented to the first 50 participants, and an interval analysis was performed for consistency of interpretation. Blocks 2 and 5 were found to have significant inconsistency and were removed from the study. Blocks 7 and 8a were added to the study set. Block 8a was found to have construction issues and was replaced by Block 8b after 20 assessments.
Procedure Part 1 Participants examined 6 Pain Blocks, presented individually. With each Pain Block presented, the subjects were directed to choose from a preprinted list of 12 pain descriptor options (derived from prior research16) with an additional free-text area for “other” (Appendix 1 provides a list of provided pain descriptors). For each block, participants had a new list of the same 12 pain qualities to choose from. To randomize the order of presentation, the Pain Blocks
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Clinical Therapeutics were kept in a covered box; they were selected by the researcher and placed in front of the participant in a blinded manner until all 6 blocks were presented. At the conclusion of the study, the blocks were placed back in the empty box. For each Pain Block, subjects were given a 1- to 2-min period to familiarize themselves with the object, and they were then directed to choose one pain quality descriptor they thought the Pain Block represented. They did so either by circling one of the descriptor quality terms from the list or filled in the “other” free text option. The sequence of Pain Block presentation was randomly ordered for each participant.
Part 2 After completion of part 1, participants were asked a series of scripted questions about a personal experience of pain. Participants were asked to “recall a recent severe pain” they had experienced, “what was it from?“, “how long ago?“, and “how bad was the pain on a scale of 1e10?” Participants were then asked if the quality of their painful experience was accurately represented by any of the presented Pain Blocks they had just been shown (“Do any of these Pain Blocks remind you of the pain you had? If so, which one?“).
Data Analysis Patient data were collected initially on paper surveys and later transcribed and managed by using Research Electronic Data Capture (REDCap).28 Data were also stored in Microsoft Excel (Microsoft Corporation, Redmond, Washington) and imported into SAS version 9.4 (SAS Institute, Inc, Cary, NC) for analysis. Descriptive data, frequencies, and percentages were first computed to assess the range of responses of the pain descriptors for each block. There were several rounds of block design presentation to participants, as described earlier. At each interval assessment, a criterion was set for a minimum consistency of at least 50% of participants associating a Pain Block with a specific quality descriptor. Pain Blocks that did not attain 50% agreement were eliminated and replaced. Subsequent analysis examined the frequency of top reported pairs of quality descriptors (often synonyms) with individual Pain Blocks (eg, “sharp” and “stabbing” or “stretching” and “tearing”).
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After the identification of Pain Blocks with the pain quality descriptor or descriptor synonym pairs, sensitivity analysis was conducted to determine if the pain descriptor with block matching was consistent between sexes. For each round of presentation, these data were calculated as percentages, and a series of c2 tests were conducted. Additional analysis was conducted to determine if experience with past pain (assessed on a 10-point scale, with 10 ¼ worst ever pain) altered the association of the block with the pain quality descriptor. The pain scores were ranked into pain quartiles to conduct this analysis. A Mantel-Haenszel c2 test of trend was conducted to evaluate the effect of increasing pain quartile on the frequency of pain descriptor selection.
RESULTS Participants In total, 357 people were approached, and 220 English-speaking non-patient participants consented and completed the study. Refusals occurred in 137 people approached; reasons for refusal to participate included “not having time” and “not interested.” Those 220 participants who completed the study each evaluated 6 individual Pain Blocks over 4 rounds of testing. Participant ages ranged from 8 to 79 years, with 50% of participants aged between 18 and 29 years; 4 (1.8%) were aged 17 years, and 5 participants were aged between 60 and 79 years (2.3%). The remaining 62 (45.9%) participants were between 30 and 59 years of age. Most participants were female (72%).
Testing Table I shows the number of participants exposed to each of the 9 blocks in each round of testing. Blocks 1, 3, 4, and 6 consistently attained an agreement rating of at least 50% on one of the pain quality descriptors at each interval assessment and were shown to all 220 participants. Block 7 had consistent interval assessment and was shown to 120 participants; Block 8a revealed an unanticipated construction failure after 20 assessments, and was replaced by Block 8b, which was shown to an additional 100 participations. Table II shows the number and percentage of the most frequent quality responses of participants for each block across the entirety of the study (Fig. 1 provides examples of the pain blocks). The criterion
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Table I.
Pain Blocks presented at each testing round.
Pain Block No.
Testing Round 1 (n ¼ 50)
Testing Round 2 (n ¼ 50)
Testing Round 3 (n ¼ 20)
Testing Round 4 (n ¼ 100)
1 2 3 4 5 6 7 8a 8b
X X X X X X
X
X
X
X X
X X
X X
X
X X X
X X X
No. Of Participants Shown Each Block 220 50 220 220 50 220 120 20 100
X ¼ administered.
of a minimum of 50% agreement of one descriptor for each individual block was not reached in the first round of testing for Blocks 2 and 5. Replacement Block 7 reached the agreement rate. Block 8a was replaced by Block 8b, which did attain the pre-set agreement rate. Table II also shows the top 2 most frequent pain quality descriptors attributed to the blocks. When synonyms are paired, the agreement rate for Block 1 (stretching and tearing) attained 81.8% agreement, Block 3 (crampy and throbbing) 90.4% agreement, Block 4 (sharp and stabbing) 99.1%, Block 6 (crushing and dull) 94.1%, Block 7 (twisting) 95.8%, and Block 8b (burning) 100%.
Sensitivity Analysis To determine the fidelity of pain descriptor selected, an analysis was conducted to assess the effects of sex and reporting of past pain independently. For sex, there was no significant difference in the selection of pain descriptor(s) between male and female subjects: for Block 1, c2 (2) ¼ 10.8, p ¼ 0.21; Block 3, c2 (2) ¼ 8.5, p ¼ 0.39; Block 4, c2 (2) ¼ 0.85, p ¼ 0.89; Block 6, c2 (2) ¼ 11.1, p ¼ 0.20; Block 7, c2 (2) ¼ 5.25, p ¼ 0.09; and Block 8b, c2 (2) ¼ 0.82, p ¼ 0.95. Table III shows the results for the Pain Blocks (1, 3, 4, 6, 7, and 8b) that attained the pre-set criterion of consistency in agreement of descriptor across the reported personal experience of past pain. We categorized the study participants’ response to their
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ratings of a prior painful experience according to their quartile of reported prior most painful experience on their responses to the 10-point scale (intensity scores for each pain quartile are also shown in Table III). To determine if frequency of selection of pain descriptor varied according to the intensity of past pain experience, we compared the frequency of selection of the most common identifier for each Pain Block (Table II) across the past pain experience quartiles. Across the quartiles of past pain experience, there was consistency in the proportion of participants selecting the quality for each block, with the exception for Block 6. Block 6 (describing crushing and dull pain) showed a significant trend for an increasing frequency for identifying this descriptor with the increase in pain quartile (c2 [24] ¼ 42.2; p ¼ 0.01).
DISCUSSION Previous literature supports the use of specific words and phrases to describe pain. In 1971, Melzack and Torgerson12 codified verbal characterization of pain into sensory, affective, and evaluative. They further divided the sensory experience into temporal, spatial, punctate pressure, incisive pressure, constrictive pressure, traction, thermal, brightness, and dullness. They found that converting the experience of pain into these verbal descriptors could be performed in a fairly reliable way, and they also reported a high level of agreement on particular dimensions of pain,
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Clinical Therapeutics
6 Table II.
Allocation of top pain descriptors across all testing rounds. Values are given as number (%) unless otherwise indicated.
Descriptor Burning Crampy Crushing Dull Electric shock Hot Sharp Stabbing Stretching Tearing Throbbing Twisting Final descriptor choice
Block 1 (n ¼ 220) 0 0
Block 2 (n ¼ 50) 2 (4) 8 (16)
Block 3 (n ¼ 220)
8 (3.6) 142 (64.5) 1 (0.45) 0 2 (0.9) 22 (10) 12 (24) 7 (3.2) 1 (0.45) 0 0 3 (1.36) 1 (2) 0 5 (2.3) 0 1 (0.45) 0 2 (4) 0 26 (11.8) 4 (8) 1 (0.45) 154 (70) 0 0 1 (0.45) 8 (16) 57 (25.9) 7 (3.18) 14 (28) 2 (0.9) Stretching and Removed after Crampy and tearing (81.8%) round 1 throbbing (90.4%)
Block 4 (n ¼ 220)
Block 5 (n ¼ 50)
0 0 0 0
1 2 3 20 1 10
1 (0.45) 0 112 (50.9) 106 (48.2) 0 1 (0.45) 0 0 Sharp and stabbing (99.1%)
(2) (4) (6) (40) (2) (20)
Block 6 (n ¼ 220) 0
Block 7 (n ¼ 120)
7 (35)
Block 8b (n ¼ 100)
100 (100) 0 0 0 0 0 2 (0.9) 13 (65) 0 0 1 (0.45) 0 0 0 0 (0.9) 0 0 5 (10) 1 (0.45) 5 (4.2) 0 0 0 1 (0.45) 0 0 0 4 (8) 4 (1.8) 0 0 0 4 (8) 0 115 (95.8) 0 0 Removed Crushing and Twisting Removed Burning after round 1 dull (94.1%) (95.8%) after round 3 (100%) 4 (1.8) 168 (76.4) 39 (17.7)
0 0 0 0 0 0 0 0
Block 8a (n ¼ 20) 0 0 0 0
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Table III.
Pain descriptor selection according to quartile of prior pain experience intensity. Values are given as no (%).
Pain Block/Descriptor
Block 1: stretching and tearing Block 3: crampy and throbbing Block 4: sharp and stabbing Block 6: crushing and dull Block 7: twisting* Block 8b: burningy
Quartile 1: Quartile 2: Quartile 3: Quartile 4: Pain Score Pain Score Pain Score Pain Score 2e4 (n ¼ 62) 5 (n ¼ 56) 6e7 (n ¼ 48) 8e10 (n ¼ 54)
Statistic
53 (85.8)
46 (82.1)
40 (83.3)
37 (64.8)
c2 (24) ¼ 28.4, p ¼ 0.24
56 (90.3)
42 (75)
42 (87.5)
41 (75.9)
c2 (24) ¼ 25.4, p ¼ 0.39
62 (100)
56 (100)
47 (97.8)
53 (98.2)
c2 (9) ¼ 9.3, p ¼ 0.41
62 (100)
55 (88.3)
47 (87.9)
42 (77.8)
c2 (24) ¼ 42.2, p ¼ 0.01
37 (95.1) 32 (98.3)
34 (98.4) 28 (100)
22 (97.8) 19 (100)
22 (100) 20 (100)
c2 (6) ¼ 11.1, p ¼ 0.09 c2 (6) ¼ 6.4, p ¼ 0.38
1, n ¼ 40; quartile 2, n ¼ 35, quartile 3, n ¼ 23; and quartile 4, n ¼ 22. Quartile 1, n ¼ 33; quartile 2, n ¼ 28, quartile 3, n ¼ 19; and quartile 4, n ¼ 20.
* Quartile y
even among those with diverse backgrounds. Additional research has supported verbal cues as helping to communicate the experience of discomfort in a medical setting.10,11,12,20 Although language is useful for communication of pain qualities between patients and providers in many circumstances, it still relies on a multi-step process of interpretation and understanding that can interfere with the accurate transfer of information. Patients must have both the language skills and the ability to characterize their experience of an ephemeral sensation into words. The words must then be interpreted by the listener. In addition, all of these steps are shaded by the participants’ emotional and physiological experience with nociception. For example, some people are unable to express their pain beyond the term “bad” when describing the quality of their severe pain. Others may use a descriptive quality term; for example “sharp,” intending the word to represent one of several concepts, including “poke,” “severe,” “cutting,” or “acute.” The present proof-of-concept study showed that individuals from different age groups, sex, and educational backgrounds were able to quickly familiarize themselves, with minimum instruction, with abstract hand-held objects and understand that
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they represent physical manifestations of a variety of pain qualities. With intentional design, careful selection, and interval testing, we were able to create 6 Pain Blocks that were consistently interpreted by naive participants to represent specific qualities of pain. We were also able to show persistence of participants' interpretation of the Pain Blocks. This was shown by having participants reflect back on a recent significant somatic pain experience, recall the experience's pain quality, and then chose which of the Pain Blocks they felt most closely represented the quality of that personal prior experience of pain. For the duration of the interview period (10e15 min), participants consistently used the same terms they had just applied to the Pain Blocks without prompting. This spanned the interval between part 1 and part 2. Our findings suggest that the interposition of a physical object into the exchange of verbal information about the patient's sensation of pain might provide a tangible haptic reference point that both participants can use to establish a shared understanding. This approach offers the potential to address problems in communicating pain symptoms across a wide array of patient populations, especially given the consistency of response across sex, age, and level of prior painful experience.
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Clinical Therapeutics There are limitations to our study design that must be considered when interpreting these results. This was a convenience sample of participants who were not in pain during their study involvement and therefore may not have provided data that could be applied to a population in acute pain. Participants were eligible only if they were competent in understanding and communicating in English; we therefore do not know if the pain descriptors applied to each block would be consistent across different languages and cultural experiences. More research is needed to test this potentially useful diagnostic tool in patient populations in which communication might be challenging, such as with young children or people with cognitive impairments (including those with psychomotor limitations).
CONCLUSIONS To our knowledge, this proof-of-concept study is the first to develop and evaluate a set of uniquely designed physical representations of pain qualities with the ultimate intent of improving shared understanding and communication of the experience of pain. We were able to show that naive participants quickly understood and associated each of the Pain Blocks with a specific quality of pain with high consistency. With the results of this preliminary research, additional studies are being designed to explore the utility and applicability of the Pain Blocks in more defined groups. Planned future work involves testing of the tool in focus groups, including: patients concurrently in pain from specific types of discomfort (eg, dental pain, renal colic); patients in specific age categories (eg, young children, elderly); and also to see whether the Pain Blocks can act as a tangible foci, to create a shared understanding between patients and health care providers in communicationlimited populations.
CONFLICTS OF INTEREST The authors have indicated that they have no conflicts of interest regarding the content of this article.
ACKNOWLEDGMENTS The authors acknowledge and thank the following people for their contributions: Erin Ryan, Zach Ricca, and Susan Park.
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Dr. Hack was responsible for conceptualization, study design, data curation, investigation, methodology, project administration, resources, supervision, validation, visualization, writing of the original draft, and reviewing and editing the manuscript. Gillian Melikian was responsible for data curation, investigation, and writing of the original draft. Clare Jessey was responsible for conceptualization, methodology, resources, visualization, and writing of the original draft. Dr. Baird was responsible for conceptualization, formal analysis, investigation, methodology, project administration, software, validation, writing of the original draft, and reviewing and editing the manuscript.
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Address for correspondence: Jason B. Hack, MD, 55 Claverick St, Providence, RI, 02903, USA. E-mail: [email protected]
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APPENDIX
Table S1. Participant Data Collection Sheet: For each of the Pain Blocks you will be handed, please complete the following assessment I think that the Pain Block ## is meant to represent this Quality of pain: “sharp” “dull” “stabbing” “burning” “crushing” “throbbing” “twisting” “electric shocks” “stretching” “crampy” “tearing” “hot” (Other)
9.e1
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