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Patients with needle phobia? Try stress-reducing medical devices

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THE J O U R N A L OF

FAMILY PRACTICE FIGURE 1

Stress-reducing syringes

was a class effect, rather than a specific effect of the individual design. Significant needle phobia is defined as aversion, fear, or anxiety scores ≥5. Using this definition, 80% of subjects experienced moderate to severe aversion, 63% suffered moderate to severe fear, and 62% experienced moderate to severe anxiety on exposure to conventional syringes. This corresponded to mean aversion, fear, and anxiety scores of 7.18 ± 1.92, 6.98 ± 2.16, and 6.78 ± 2.44, respectively. In subjects with significant needle phobia, stressreducing syringes reduced aversion scores by 81% (P<.001), fear scores by 56% (P<.001), and anxiety by 47% (P<.001). Stress-reducing syringes had a positive response rate of 98% for reducing aversion, 87% in reducing fear, and 74% in reducing anxiety. Stress-reducing butterfly needles reduced aversion by 68%, fear by 53%, and anxiety by 53% (P<.001). The stressreducing designs most favored were butterfly designs, flowers, fish, and smiley faces. Stress-reducing IV bags significantly reduced aversion by 83%, fear by 53%, and anxiety by 73% (P<.001). Stressreducing scalpels also significantly reduced aversion by 49%, fear by 36%, and anxiety by 37% (P<.001). When analyzed separately, both children and adults responded favorably and scales where 0tois the lowest response anddevices 10 similarly stress-reducing in 8–11 is all the 3 strongest. These included domains (P<.01), although children the Visual Anxiety Scale level (VAAS), had aAnalogue higher mean stress in all 3 Visual Analogue Fear Scale (VAFS), domains to conventional devices (P<.05). and Visual Analogue Aversion Scale (VAS). Significant needle phobia was defined as an aversion, fear, or anxiety score of greater ❚ Discussion than or equal to 5.

A fear of needles, syringe procedures, intra-

Stress-reducing syringes (compared with 3 typical conventional syringes at right) yielded a mean 79% decrease in aversion scores, 53% decrease in fear scores, and 51% decrease in anxiety scores. Musical notes were the most favored design (P<.001).

FIGURE 2 Stress-reducing butterfly needles

venous therapy, Statistical analysisand medical devices is given the overall term of needle phobia, and can Primary analyses consisted of comparing 1–7 seriously compromise patient care. the responses to the stress-reducing devicesAdults phobia verbally or even as a may classexpress with theneedle conventional devices as avoid coming to the office, while a class. These paired dataphysician’s were compared be t-test. moreToovertly fearful, withchildren the pairedmay 2-tailed determine whether theseor responses were class-specific anxious, hysterical. Our study focused on or design-specific, the results for each indithe specific psychological components of vidual device were then with a stress—aversion, fear,compared and anxiety—induced matched control,todesign byand design, again by exposure needles medical devices. with the paired 2-tailed t-test. Corrections were made for multiple comparisons. w w w. j f p o n l i n e . c o m

Research TA B L E

Significant reductions in aversion, fear, and anxiety with stress-reducing syringes CONVENTIONAL SYRINGES

STRESSREDUCING SYRINGES

P VALUE

Aversion

5.88 ± 3.61

1.21 ± 1.64

P<.001

79%

Fear

4.68 ± 2.8

2.19 ± 2.8

P<.001

53%

Anxiety

51%

60 SUBJECTS’ EXPERIENCES

4.54 ± 3.68

2.21 ± 2.84

P<.001

Most liked

5%

95%

P<.001

Most disliked

95%

5%

P<.001

Aversion, fear, and anxiety were each assessed with the relevant VAS, a reproducible and validated method for assessing stress components in clinical populations.8–11 Using a conservative definition for moderate to severe stress (VAS ≥5), 80% of subjects experienced moderate to severe aversion, 63% suffered moderate to severe fear, and 62% experienced moderate to severe anxiety in response to conventional devices. Thus, significant levels of clinically relevant needle phobia are present in typical outpatient populations. Several approaches have been taken to prevent and treat needle phobia, including reassurance, education, avoidance of needles, postural and muscle tension techniques, benzodiazepines, nitrous oxide gas, topical anesthesia, cognitive therapy, participant modeling, distraction, meditation, hypnosis, and coaching—all with variable and inconsistent results.1–7,12–18 We hypothesized that visual modifications to needles, syringes, and other medical devices would result in stress-reducing devices that would lessen patient needle phobia. The stress-reducing needles and medical devices were created by applying simple representative designs on winged needles, syringes, IV bags, and scalpels while maintaining the basic function of these devices (FIGURES 1–3 ). Stress-reducing syringes resulted in a 79% decrease in aversion, 53% reduction VOL 55, NO 8 / AUGUST 2006

% DECREASE IN SCORE

FAST TRACK

In those with significant needle phobia, stressreducing syringes reduced aversion scores by 81%

699

❚ Results

FAST TRACK

95% of subjects preferred the decorated syringes; 98% felt they should be available for children

%

698

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Patients experienced markedly more aversion to (dislike of) conventional syringes (VAAS score: 5.88 ± 3.61 vs stress-reducing syringes VAAS score: 1.21 ± 1.64; P<.001); they also had greater fear (conventional VAFS score: 4.68 ± 2.8 vs stressreducing VAFS score: 2.19 ± 2.8, P<.001) and anxiety (conventional VAS score: 4.54 Stress-reducing butterfly needles (compared with 4 ± 3.68 vs stress-reducing VAS score: 2.21 ± typical designs at bottom) reduced aversion by 68%, 2.84, P<.001) (TABLE ). This corresponds to fear by 53%, and anxiety by 53% (P<.001). a mean 79% decrease in aversion scores, 53% reduction in fear scores, and 51% FIGURE 3 Stress-reducing IV bags decrease in anxiety scores with the stressTHE J O U R N A L OF reducing syringes. Ninety-five percent of subjects preferred the stress-reducing syringes to the conventional syringes; 98% of subjects felt that stress-reducing syringes in fear, and 51% decrease in anxiety in the should be available for children; 72% felt overall patient population compared to the that the stress-reducing syringes should conventional syringes (P <.001). M ore also be available for adults. importantly, in subjects with significant The syringes most favored were those needle phobia (VAS scores ≥5), stresswith musical notes (56%), flowers (18%), reducing syringes reduced aversion by and smiley faces (12%). Each of these 81%, fear by 56%, and anxiety by 47% designs had lower scores in the 3 domains (P <.001). This corresponds to favorable (fear, aversion, and anxiety) compared responses of 98% for aversion, 87% for with the conventional device (P<.01), indi- fear, and 74% in anxiety in subjects with Stress-reducing intravenous bags reduced aversion by cating that the reduction in stress measures needle phobia. Similarly, stress-reducing 83%, fear by 53%, and anxiety by 73% (P<.001). winged needles, IV bags, and scalps in needle-phobic individuals demonstrated signifVOL 55, NO 8 / AUGUST 2006 THE JOURNAL OF FAMILY PRACTICE icantly positive response rates for reducing aversion, fear, and anxiety. For the stressreducing devices, each individual design was superior to the corresponding conventional device, indicating a dominant class effect of these stress-reducing medical devices, rather than the specific design.

FAMILY PRACTICE

C?A% FAST TRACK

The decoration of medical devices may be a neurophysiologic intervention, stimulating brain areas not associated with fear and anxiety

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Damping visual cues of threat It is likely that decoration of a medical device actually is a neurophysiologic intervention, resulting in stimulation of brain areas not usually associated with the fear, anxiety, and aversion responses caused by viewing medical devices. In this sense, the intervention of decorating a medical device has a close parallel to other cognitive, distraction, and mind-body imagery methods of intervention.1–7,12–18 H owever, unlike these other interventions, decoration of the medical device actually focuses the patient’s attention and interest on the medical device, yet fear, aversion, and anxiety of needles and syringes are still significantly reduced. This suggests that the decorations interfere with the established link between visual recognition of a perceived threat and the subsequent emotional response to that perceived threat. In the future, neuroimaging of brain activation in response to these decorated devices may provide a more telling explanation of their stress-reducing effects. This study demonstrates unexpectedly high levels of stress and fear of medical devices in typical clinic patients, and significant reduction of these stress measures by the use of stress-reducing decorated med-

ical devices. The most favorable implementation of this technology would be for these stress-reducing medical devices to be massproduced and the decorations placed on the device at the factory rather at the site of service. Ultimate implementation of this technology will determined primarily by economic considerations and the acceptance of these aesthetic modifications by nursing, physician, and administrative staff in family practice units. ■ REFERENCES

1. Fassler D. The fear of needles in children. Am J Orthopsychiatry 1985; 55:371–377. 2. Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract 1995; 41:169–175. 3. McSherry J. Perspectives on needle phobia. J Fam Pract 1995; 41:437,512. 4. Daniels AJ. Perspectives on needle phobia. J Fam Pract 1995;41:437. 5. Stark MM, Brener N. Needle phobia. J Clin Forensic Med 2000;7:35-8. 6. Smalley A. Needle phobia. Paediatr Nurs 1999;11:17–20. 7. Hedstrom M, Haglund K, Skolin I, von Essen L. Distressing events for children and adolescents with cancer: child, parent, and nurse perceptions. J Pediatr Oncol Nurs 2003; 20:120–132. 8. Ferguson JM, Taylor CB, Wermuth B. A rapid behavioral treatment for needle phobics. J Nerv Ment Dis 1978; 166:294–298. 9. Ferguson JM, Wermuth BM, Taylor CB. Rapid desensitization of a needle phobia by participant modeling. West J Med 1976; 124:174–176. 10. Mumford O. Patient tips from industry. Coping with needle phobia. Diabetes Educ 2004; 30:174. 11. Koppel SM, Thapar A. Treating blood needle phobia. Hosp Med 1998; 59:730-732. 12. Dahlquist LM, Busby SM, Slifer KJ, et al. Distraction for children of different ages who undergo repeated needle sticks. J Pediatr Oncol Nurs 2002; 19:22–34. 13. Speirs AF, Taylor KH, Joanes DN, Girdler NM. A randomised, double-blind, placebo-controlled, comparative study of topical skin analgesics and the anxiety and discomfort associated with venous cannulation. Br Dent J 2001; 190:444–449. 14. Kleiber C, Craft-Rosenberg M, Harper DC. Parents as distraction coaches during i.v. insertion: a randomized study. J Pain Symptom Manage 2001; 22:851–861. 15. Bhachu HS, Kay B, Healy TE, Beatty P. Grading of pain and anxiety. Comparison between a linear analogue and a computerised audiovisual analogue scale. Anaesthesia 1983; 38:875–878. 16. Miller MD, Ferris DG. Measurement of subjective phenomena in primary care research: the Visual Analogue Scale. Fam Pract Res J 1993; 13:15–24. 17. Salomon JA, Murray CJ. A multi-method approach to measuring health-state valuations. Health Econ 2004; 13:281–290. 18. Chapman HR, Kirby-Turner N. Visual/verbal analogue scales: examples of brief assessment methods to aid management of child and adult patients in clinical practice. Br Dent J 2002; 193:447–450.

VOL 55, NO 8 / AUGUST 2006 THE JOURNAL OF FAMILY PRACTICE


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ORIGINAL ARTICLE

The Effect of Foot and Ankle Prosthetic Components on Braking and Propulsive Impulses During Transtibial Amputee Gait Robert J. Zmitrewicz, MS, Richard R. Neptune, PhD, Judith G. Walden, MPH, William E. Rogers, MS, Gordon W. Bosker, MEd, CPO, LPO, CPed ABSTRACT. Zmitrewicz RJ, Neptune RR, Walden JG, Rogers WE, Bosker GW. The effect of foot and ankle prosthetic components on braking and propulsive impulses during transtibial amputee gait. Arch Phys Med Rehabil 2006;87: 1334-9. Objective: To assess the influence of energy storage and return (ESAR) prosthetic feet and multi-axis ankles on ground reaction forces and loading asymmetry between lower limbs in transtibial amputees. Design: Subjects wore 2 different prosthetic feet with and without a multi-axis ankle and were analyzed using a blind repeated-measures multivariate analysis-of-variance design. Setting: Gait analysis laboratory. Participants: Fifteen healthy unilateral transtibial amputees (!55y) who had an amputation at least 1 year before testing because of vascular disorders. Interventions: Not applicable. Main Outcome Measures: The anteroposterior ground reaction force impulse, peak ground reaction forces, and braking and propulsion impulse duration were analyzed as subjects walked at a self-selected speed while wearing each of the 4 foot-ankle prosthesis combinations. Statistical analyses were used to determine if there was a significant foot, ankle, or foot-ankle interaction effect on the outcome measures for each foot (P".05). Results: Amputees generated a significantly greater propulsive impulse with the residual leg when wearing a multi-axis ankle with the ESAR and non-ESAR foot, which improved the propulsive symmetry between the residual and intact legs. There was no prosthetic foot effect on these measures. There were no significant differences in the peak residual-leg braking or propulsive ground reaction forces or the impulse durations due to the prosthetic foot, ankle, or foot-ankle interactions, although an increase in the propulsive impulse duration approached significance (P#.062) with a multi-axis ankle. Conclusions: These results suggest that amputee gait may improve with the prescription of multi-axis ankles that allow

From the Department of Mechanical Engineering, University of Texas, Austin, TX (Zmitrewicz, Neptune); Physical Medicine and Rehabilitation Service, South Texas Veterans Health Care System/Audie L. Murphy Division, San Antonio, TX (Walden); and Department of Rehabilitation Medicine, University of Texas Health Science Center, San Antonio, TX (Rogers, Bosker). Supported by the National Science Foundation (grant no. BES-0346514) and the Veterans Affairs Office of Research and Development (grant no. A27731-i). No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the author(s) or upon any organization with which the author(s) is/are associated. Reprint requests to Richard R. Neptune, PhD, Dept of Mechanical Engineering, University of Texas, 1 University Station C2200, Austin, TX 78712, e-mail: rneptune@mail.utexas.edu. 0003-9993/06/8710-10767$32.00/0 doi:10.1016/j.apmr.2006.06.013

for greater propulsive impulses by the residual leg, which improve the loading symmetry between legs. Key Words: Amputees; Rehabilitation; Walking. 1338 GROUNDMediREACTION FORCE IMPULSES IN © 2006 by the American Congress of Rehabilitation cine and the American Academy of Physical Medicine and Rehabilitation meet the cultural and socioeconomic needs of amputees in India) foot have been previously reported by Arya et al.12 The braking impulses for the Seattle and SACH feet were 2.94% HE PRESCRIPTION and OF 2.88% the optimal body prosthetic weight percomposecond (scaled from N·s/kg), nents to ensure a successful amputeeand rehabilitation remains respectively, their propulsive impulse results were 2.78% a challenging problem, because there are no generally accepted and 2.83% body weight per second (scaled from N·s/kg), Prescriptionbraking of clinical guidelines based respectively. on objective These data.1 residual-leg and propulsive improsthetic feet is often derived fromslightly the successful clinical pulses were higher than our values, which could be the experience of a prosthetistresult rather biomechanic data and of than different walking speeds tested (not reported in their 2 The scientific justification for specific prosthetictheir components. study). However, results were consistent with our data in lack of biomechanic guidelines is especially pertinent with braking than propulsive that the residual leg produced a greater regard to energy storage and returnand (ESAR) Mechanically, impulse in thatfeet. there was little difference in the braking or ESAR feet store elastic energy in early stance between and midstance, propulsive impulses the SACH and Seattle (ESAR) and they release it in late stance feet. and preswing to provide some of the mechanical energy normally provided by thebraking ankle and propulsive impulse The residual-to-intact–leg plantarflexors. However, previous studies havethe notrelative pro- loading symmetry beratios were used often to assess tween the residual in andvarious intact kinesilegs. The residual-to-intact–leg duced statistically significant improvements propulsive impulse increased (ie, the residual leg generologic measures (eg, preferred walking speed,ratio cadence, stride ated a greater propulsive impulse and symmetry was improved) length, muscle activity, energy expenditure) when amputees with the of multi-axis ankles (see table 2). The wore ESAR versus non-ESAR feetaddition (eg, conventional solid2 SACH-MA produced best combination of residual-to-infor reankle cushion-heel [SACH] feet). (See Hafner the et al tact–leg braking and propulsive ratios (ie, the average braking view.) and propulsion was the A recent survey of lower-leg amputeesratio showed thathighest, balanceat .86) (see table 2). After testing completion, eachwalking subject was confidence and stability correlated strongly with per-allowed to keep the footankle3 prosthesis they most preferred. Stability is increased with aEleven of the 15 subjects formance and social activity. others foot-flat posture, which ispreferred delayed the in SACH-MA. early stance Three relative to preferred the CCII-MA, 1 preferred the ankle SACH.range Theseof results suggest that patient nonamputees because of while limited prosthesis preference be related to to actively loading symmetry and the ability of may plantarflexors motion (ROM)4 and the absence to generate increased propulsion with the residual leg with the provide a foot-flat posture. As a result, the amount of time multi-axis ankles. amputees spend with heel-only contact with the ground before limitation this study is that we focused on a achieving a foot-flat postureAis potential nearly twice that ofofnonampuconsisting solely older vascular amputees. Future compromised balance and of stability. tees,5 which may result inpopulation work should be ESAR directedfoot toward whether similar In addition, a recent comparison of an withidentifying a benefits are observed in younger, traumatic amputees, because conventional non-ESAR foot suggested that patient preference they may be better suited to take advantage of the increased for the ESAR foot was based on increased power absorption in the prosthetic ankle during weight acceptance, as well as increased ankle ROM that allowed a foot-flat posture in response to uneven terrain.6 Thus, ankle ROM appears to be an important characteristic when designing and selecting foot-ankle components. To improve ankle ROM, prosthetic feet are often combined with a multi-axis ankle that allows full foot ROM with respect to the lower-leg prosthesis. However, it is not clear how the multi-axis ankle affects the biomechanic performance of the foot. Ground reaction forces are important biomechanic measures to analyze because amputees are at increased risk of developing joint disorders in the intact leg as a result of increased leg loading,4,7,8 and the ground reaction forces reflect the motion of the body’s center of mass. Studies have shown the intact leg

T

Arch Phys Med Rehabil Vol 87, October 2006

Fig 1. Group average residual- and intact-leg AP ground reaction force patterns (GRF) for the 4 foot-ankle combinations. Arch Phys Med Rehabil Vol 87, October 2006

TRANSTIBIAL AMPUTEE GAIT, Zmitrewicz

ankle ROM and energy storage features of ESAR feet. In addition, this study only evaluated biomechanic measures without measuring the corresponding metabolic cost. The effect of ESAR feet on metabolic cost has varied between studies (see Hafner et al2 for review), and it is not clear what effect multi-axis ankles will have on metabolic energy expenditure. CONCLUSIONS Our results show that the addition of multi-axis ankles to prosthetic feet improves the ability of amputees to generate propulsive impulses with the residual leg and thereby helps improve the loading symmetry between the residual and intact legs. The results also suggest that older, vascular amputees may not benefit from the increased energy storage and return provided by ESAR feet but do benefit from the increased flexibility provided by multi-axis ankles. Fourteen of the 15 subjects preferred a prosthesis with a multi-axis ankle, and 11 of the 15 subjects preferred the prosthesis that best improved the loading symmetry between the residual and intact legs. These results provide some scientific rationale for prescribing multi-axis ankles to improve amputee gait performance. Acknowledgment: We thank Nancy Heger, PhD, for her help with the statistical analyses. References 1. Cortes A, Viosca E, Hoyos JV, Prat J, Sanchez-Lacuesta J. Optimisation of the prescription for trans-tibial (TT) amputees. Prosthet Orthot Int 1997;21:168-74. 2. Hafner BJ, Sanders JE, Czerniecki J, Fergason J. Energy storage and return prostheses: does patient perception correlate with biomechanical analysis? Clin Biomech (Bristol, Avon) 2002;17: 325-44. 3. Miller WC, Deathe AB, Speechley M, Koval J. The influence of falling, fear of falling, and balance confidence on prosthetic mobility and social activity among individuals with a lower extremity amputation. Arch Phys Med Rehabil 2001;82:1238-44. 4. Burke MJ, Roman V, Wright V. Bone and joint changes in lower limb amputees. Ann Rheum Dis 1978;37:252-4. 5. Powers CM, Rao S, Perry J. Knee kinetics in trans-tibial amputee gait. Gait Posture 1998;8:1-7. 6. Underwood HA, Tokuno CD, Eng JJ. A comparison of two prosthetic feet on the multi-joint and multi-plane kinetic gait compensations in individuals with a unilateral trans-tibial amputation. Clin Biomech (Bristol, Avon) 2004;19:609-16. 7. Norvell DC, Czerniecki JM, Reiber GE, Maynard C, Pecoraro JA, Weiss NS. The prevalence of knee pain and symptomatic knee osteoarthritis among veteran traumatic amputees and nonamputees. Arch Phys Med Rehabil 2005;86:487-93. 8. Fisher SV, Gullickson G Jr. Energy cost of ambulation in health and disability: a literature review. Arch Phys Med Rehabil 1978; 59:124-33. 9. Snyder RD, Powers CM, Fontaine C, Perry J. The effect of five prosthetic feet on the gait and loading of the sound limb in dysvascular below-knee amputees. J Rehabil Res Dev 1995;32: 309-15. 10. Sanderson DJ, Martin PE. Lower extremity kinematic and kinetic adaptations in unilateral below-knee amputees during walking. Gait Posture 1997;6:126-36. 11. Powers CM, Torburn L, Perry J, Ayyappa E. Influence of prosthetic foot design on sound limb loading in adults with unilateral below-knee amputations. Arch Phys Med Rehabil 1994;75:825-9. 12. Arya AP, Lees A, Nirula HC, Klenerman L. A biomechanical comparison of the SACH, Seattle and Jaipur feet using ground reaction forces. Prosthet Orthot Int 1995;19:37-45. 13. Lehmann JF, Price R, Boswell-Bessette S, Dralle A, Questad K, deLateur BJ. Comprehensive analysis of energy storing prosthetic


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