Trials | |
Efficacy of a children’s procedural preparation and distraction device on healing in acute burn wound care procedures: study protocol for a randomized controlled trial | |
Leila Cuttle2  Roy M Kimble2  Robert S Ware1  Sylvia Rodger3  Nadia J Brown2  | |
[1] The University of Queensland, School of Population Health, Brisbane, Queensland, Australia;Centre for Children’s Burns and Trauma Research, Queensland Children’s Medical Research Institute, University of Queensland, Royal Children’s Hospital, Brisbane, Queensland, Australia;Division of Occupational Therapy, The University of Queensland, School of Health & Rehabilitation Sciences, Brisbane, Queensland, Australia | |
关键词: Randomized clinical trial; Virtual reality; Salivary alpha-amylase; Salivary cortisol; Anxiety; Stress; Pain; Child; Burns; | |
Others : 1095060 DOI : 10.1186/1745-6215-13-238 |
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received in 2012-07-23, accepted in 2012-11-27, 发布年份 2012 | |
【 摘 要 】
Background
The intense pain and anxiety triggered by burns and their associated wound care procedures are well established in the literature. Non-pharmacological intervention is a critical component of total pain management protocols and is used as an adjunct to pharmacological analgesia. An example is virtual reality, which has been used effectively to dampen pain intensity and unpleasantness. Possible links or causal relationships between pain/anxiety/stress and burn wound healing have previously not been investigated. The purpose of this study is to investigate these relationships, specifically by determining if a newly developed multi-modal procedural preparation and distraction device (Ditto™) used during acute burn wound care procedures will reduce the pain and anxiety of a child and increase the rate of re-epithelialization.
Methods/design
Children (4 to 12 years) with acute burn injuries presenting for their first dressing change will be randomly assigned to either the (1) Control group (standard distraction) or (2) Ditto™ intervention group (receiving Ditto™, procedural preparation and Ditto™ distraction). It is intended that a minimum of 29 participants will be recruited for each treatment group. Repeated measures of pain intensity, anxiety, stress and healing will be taken at every dressing change until complete wound re-epithelialization. Further data collection will aid in determining patient satisfaction and cost effectiveness of the Ditto™ intervention, as well as its effect on speed of wound re-epithelialization.
Discussion
Results of this study will provide data on whether the disease process can be altered by reducing stress, pain and anxiety in the context of acute burn wounds.
Trial registration
ACTRN12611000913976
【 授权许可】
2012 Brown et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
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20150130181204182.pdf | 844KB | download | |
Figure 2. | 116KB | Image | download |
Figure 1. | 80KB | Image | download |
【 图 表 】
Figure 1.
Figure 2.
【 参考文献 】
- [1]Loeser JD, Melzack R: Pain: an overview. Lancet 1999, 353:1607-1609.
- [2]Tracey I: Imaging pain. Br J Anaesth 2008, 101:32-39.
- [3]Summer GJ, Puntillo KA, Miaskowski C, Green PG, Levine JD: Burn injury pain: the continuing challenge. J Pain 2007, 8:533-548.
- [4]Thurber CA, Martin-Herz SP, Patterson DR: Psychological principles of burn wound pain in children. I: Theoretical framework. J Burn Care Rehabil 2000, 21:376-387.
- [5]Spielberger CD: State-Trait Anxiety Inventory. New York, NY: John Wiley & Sons; 2010.
- [6]Connor-Ballard PA: Understanding and managing burn pain: part 2. Am J Nurs 2009, 109:54-62. quiz 63
- [7]Chapman CR: Psychological Factors in Postoperative Pain. In Acute Pain. Edited by Smith G, Covino BG. London, UK: Butterworth-Heinemann; 1985:22-41.
- [8]LaMontagne LL, Hepworth JT, Salisbury MH: Anxiety and postoperative pain in children who undergo major orthopedic surgery. Appl Nurs Res 2001, 14:119-124.
- [9]Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC: Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics 2006, 118:651-658.
- [10]Stoddard FJ, Saxe G, Ronfeldt H, Drake JE, Burns J, Edgren C, Sheridan R: Acute stress symptoms in young children with burns. J Am Acad Child Adolesc Psychiatry 2006, 45:87-93.
- [11]De Young AC, Kenardy JA, Cobham VE, Kimble R: Prevalence, comorbidity and course of trauma reactions in young burn injured children. J Child Psychol Psychiatry 2012, 53:56-63.
- [12]Marucha PT, Kiecolt-Glaser JK, Favagehi M: Mucosal wound healing is impaired by examination stress. Psychosom Med 1998, 60:362-365.
- [13]Kiecolt-Glaser JK, Loving TJ, Stowell JR, Malarkey WB, Lemeshow S, Dickinson SL, Glaser R: Hostile marital interactions, proinflammatory cytokine production, and wound healing. Arch Gen Psychiatry 2005, 62:1377-1384.
- [14]Glaser R, Kiecolt-Glaser PK, Marucha PT, MacCallum RC, Laskowski BF, Malarkey WB: Stress-related changes in proinflammatory cytokine production in wounds. Arch Gen Psychiatry 1999, 56:450-456.
- [15]Broadbent E, Petrie KJ, Alley PG, Booth RJ: Psychological stress impairs early wound repair following surgery. Psychosom Med 2003, 65:865-869.
- [16]Sternberg EM, Sternberg EM: Neural regulation of innate immunity: a coordinated nonspecific host response to pathogens. Nat Rev Immunol 2006, 6:318-328.
- [17]Chrousos GP: Stressors, stress, and neuroendocrine integration of the adaptive response. The 1997 Hans Selye Memorial Lecture. Ann N Y Acad Sci 1998, 851:311-335.
- [18]DeRijk R, Michelson D, Karp B, Petrides J, Galliven E, Deuster P, Paciotti G, Gold PW, Sternberg EM: Exercise and circadian rhythm-induced variations in plasma cortisol differentially regulate interleukin-1 beta (IL-1 beta), IL-6, and tumor necrosis factor-alpha (TNF alpha) production in humans: high sensitivity of TNF alpha and resistance of IL-6. J Clin Endocrinol Metab 1997, 82:2182-2191.
- [19]Glaser R, Kiecolt-Glaser JK: Science and society - stress-induced immune dysfunction: implications for health. Nat Rev Immunol 2005, 5:243-251.
- [20]Romana-Souza B, Otranto M, Vieira AM, Filgueiras CC, Fierro IM, Monte-Alto-Costa A: Rotational stress-induced increase in epinephrine levels delays cutaneous wound healing in mice. Brain Behav Immun 2010, 24:427-437.
- [21]Christian LM, Graham JE, Padgett DA, Glaser R, Kiecolt-Glaser JK: Stress and wound healing. Neuroimmunomodulation 2006, 13:337-346.
- [22]Park JE, Barbul A: Understanding the role of immune regulation in wound healing. Am J Surg 2004, 187:S11-S16.
- [23]Vileikyte L: Stress and wound healing. Clin Dermatol 2007, 25:49-55.
- [24]Rozlog LA, Kiecolt-Glaser JK, Marucha PT, Sheridan JF, Glaser R: Stress and immunity: implications for viral disease and wound healing. J Periodontol 1999, 70:786-792.
- [25]Yamasaki K, Edington HD, McClosky C, Tzeng E, Lizonova A, Kovesdi I, Steed DL, Billiar TR: Reversal of impaired wound repair in iNOS-deficient mice by topical adenoviral-mediated iNOS gene transfer. J Clin Invest 1998, 101:967-971.
- [26]Schwentker A, Vodovotz Y, Weller R, Billiar TR: Nitric oxide and wound repair: role of cytokines? Nitric Oxide 2002, 7:1-10.
- [27]Elenkov IJ, Webster EL, Torpy DJ, Chrousos GP: Stress, corticotropin-releasing hormone, glucocorticoids, and the immune/inflammatory response: acute and chronic effects. Ann N Y Acad Sci 1999, 876:1-11. discussion 11–13
- [28]Baum CL, Arpey CJ: Normal cutaneous wound healing: clinical correlation with cellular and molecular events. Dermatol Surg 2005, 31:674-686.
- [29]Hoffman HG, Doctor JN, Patterson DR, Carrougher GJ, Furness TA 3rd: Virtual reality as an adjunctive pain control during burn wound care in adolescent patients. Pain 2000, 85:305-309.
- [30]Hoffman HG, Patterson DR, Magula J, Carrougher GJ, Zeltzer K, Dagadakis S, Sharar SR: Water-friendly virtual reality pain control during wound care. J Clin Psychol 2004, 60:189-195.
- [31]Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR: Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain 2001, 17:229-235.
- [32]Sharar SR, Miller W, Teeley A, Soltani M, Hoffman HG, Jensen MP, Patterson DR: Applications of virtual reality for pain management in burn-injured patients. Expert Rev Neurother 2008, 8:1667-1674.
- [33]Miller K, Rodger S, Kipping B, Kimble RM: A novel technology approach to pain management in children with burns: a prospective randomized controlled trial. Burns 2011, 37:395-405.
- [34]Miller K, Rodger S, Bucolo S, Greer R, Kimble RM: Multi-modal distraction. Using technology to combat pain in young children with burn injuries. Burns 2010, 36:647-658.
- [35]Hoffman HG, Sharar SR, Coda B, Everett JJ, Ciol M, Richards T, Patterson DR: Manipulating presence influences the magnitude of virtual reality analgesia. Pain 2004, 111:162-168.
- [36]Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH: The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr 2005, 5:1. BioMed Central Full Text
- [37]Chan EA, Chung JW, Wong TK, Lien AS, Yang JY: Application of a virtual reality prototype for pain relief of pediatric burn in Taiwan. J Clin Nurs 2007, 16:786-793.
- [38]Hoffman HG, Patterson DR, Seibel E, Soltani M, Jewett-Leahy L, Sharar SR: Virtual reality pain control during burn wound debridement in the hydrotank. Clin J Pain 2008, 24:299-304.
- [39]Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM: The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns 2008, 34:803-808.
- [40]Hoffman HG, Richards TL, Coda B, Bills AR, Blough D, Richards AL, Sharar SR: Modulation of thermal pain-related brain activity with virtual reality: evidence from fMRI. Neuroreport 2004, 15:1245-1248.
- [41]Valet M, Sprenger T, Boecker H, Willoch F, Rummeny E, Conrad B, Erhard P, Tolle TR: Distraction modulates connectivity of the cingulo-frontal cortex and the midbrain during pain: an fMRI analysis. Pain 2004, 109:399-408.
- [42]Miller K, Bucolo S, Patterson E, Kimble RM: The emergence of multi-modal distraction as a paediatric pain management tool. Stud Health Technol Inform 2008, 132:287-292.
- [43]Kipping B, Rodger S, Miller K, Kimble RM: Virtual reality for acute pain reduction in adolescents undergoing burn wound care: a prospective randomized controlled trial. Burns 2012, 38:650-657.
- [44]Lund CC, Browder NC: The estimation of areas of burns. Surg Gynecol Obstet 1944, 79:352-358.
- [45]McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L, PedIMMPACT: Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain 2008, 9:771-783.
- [46]von Baeyer CL, Spagrud LJ: Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain 2007, 127:140-150.
- [47]Ratcliff S, Brown A, Rosenberg L, Rosenberg M, Robert R, Cuervo L, Villarreal C, Thomas C, Meyer W III: The effectiveness of a pain and anxiety protocol to treat the acute pediatric burn patient. Burns 2006, 32:554-562.
- [48]Goodenough B, Thomas W, Champion G, Perrott D, Taplin J, von Baeyer C, Ziegler J: Unravelling age effects and sex differences in needle pain: ratings of sensory intensity and unpleasantness of venipuncture pain by children and their parents. Pain 1999, 80:179-190.
- [49]Choinière M, Melzack R, Rondeau J, Girard N, Paquin MJ: The pain of burns: characteristics and correlates. J Trauma 1989, 29:1531-1539.
- [50]Vogelsang J: The Visual Analog Scale: an accurate and sensitive method for self-reporting preoperative anxiety. J Post Anesth Nurs 1988, 3:235-239.
- [51]Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D: The Visual Analog Scale allows effective measurement of preoperative anxiety and detection of patients’ anesthetic concerns. Anesth Analg 2000, 90:706-712.
- [52]Chlan LL: Relationship between two anxiety instruments in patients receiving mechanical ventilatory support. J Adv Nurs 2004, 48:493-499.
- [53]Davey HM, Barratt AL, Butow PN, Deeks JJ: A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. J Clin Epidemiol 2007, 60:356-360.
- [54]Bringuier S, Dadure C, Raux O, Dubois A, Picot MC, Capdevila X: The perioperative validity of the Visual Analog Anxiety Scale in children: a discriminant and useful instrument in routine clinical practice to optimize postoperative pain management. Anesth Analg 2009, 109:737-744.
- [55]Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB: The Yale Preoperative Anxiety Scale: how does it compare with a “gold standard”? Anesth Analg 1997, 85:783-788.
- [56]McWhinney BC, Briscoe SE, Ungerer JP, Pretorius CJ: Measurement of cortisol, cortisone, prednisolone, dexamethasone and 11-deoxycortisol with ultra high performance liquid chromatography–tandem mass spectrometry: application for plasma, plasma ultrafiltrate, urine and saliva in a routine laboratory. J Chromatogr B Analyt Technol Biomed Life Sci 2010, 878:2863-2869.
- [57]Postert C, Averbeck-Holocher M, Beyer T, Müller J, Furniss T: Five systems of psychiatric classification for preschool children: do differences in validity, usefulness and reliability make for competitive or complimentary constellations? Child Psychiatry Hum Dev 2009, 40:25-41.
- [58]Kenardy JA, Spence SH, Macleod AC: Screening for posttraumatic stress disorder in children after accidental injury. Pediatrics 2006, 118:1002-1009.
- [59]Brewin CR, Rose S, Andrews B, Green J, Tata P, McEvedy C, Turner S, Foa EB: Brief screening instrument for post-traumatic stress disorder. Br J Psychiatry 2002, 181:158-162.
- [60]Beck JG, Sloan DM: The Oxford Handbook of Traumatic Stress Disorders. New York, USA: Oxford University Press; 2012.
- [61]Miller K, Rodger S, Bucolo S, Wang X-Q, Kimble RM: [Multimodal distraction to relieve pain in children undergoing acute medical procedures]. Zhonghua Shao Shang Za Zhi 2009, 25:352-356.
- [62]Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J: Hypertrophic burn scars: analysis of variables. J Trauma 1983, 23:895-898.
- [63]Young K: Pediatric procedural pain. Ann Emerg Med 2005, 45:160-171.