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Open Access 01-12-2016 | Study protocol

Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial

Authors: Stephen J. Chester, Kellie Stockton, Alexandra De Young, Belinda Kipping, Zephanie Tyack, Bronwyn Griffin, Ralph L. Chester, Roy M. Kimble

Published in: Trials | Issue 1/2016

Abstract

Background

Burns and the associated wound care procedures can be extremely painful and anxiety-provoking for children. Burn injured children and adolescents are therefore at greater risk of experiencing a range of psychological reactions, in particular posttraumatic stress disorder, which can persist for months to years after the injury. Non-pharmacological intervention is critical for comprehensive pain and anxiety management and is used alongside pharmacological analgesia and anxiolysis. However, effective non-pharmacological pain and anxiety management during pediatric burn procedures is an area still needing improvement. Medical hypnosis has received support as a technique for effectively decreasing pain and anxiety levels in adults undergoing burn wound care and in children during a variety of painful medical procedures (e.g., bone marrow aspirations, lumbar punctures, voiding cystourethrograms, and post-surgical pain). Pain reduction during burn wound care procedures is linked with improved wound healing rates. To date, no randomized controlled trials have investigated the use of medical hypnosis in pediatric burn populations. Therefore this study aims to determine if medical hypnosis decreases pain, anxiety, and biological stress markers during wound care procedures; improves wound healing times; and decreases rates of traumatic stress reactions in pediatric burn patients.

Methods/Design

This is a single-center, superiority, parallel-group, prospective randomized controlled trial. Children (4 to 16 years, inclusive) with acute burn injuries presenting for their first dressing application or change are randomly assigned to either the (1) intervention group (medical hypnosis) or (2) control group (standard care). A minimum of 33 participants are recruited for each treatment group. Repeated measures of pain, anxiety, stress, and wound healing are taken at every dressing change until ≥95 % wound re-epithelialization. Further data collection assesses impact on posttraumatic stress symptomatology, speed of wound healing, and parent perception of how easy the dressing change is for their child.

Discussion

Study results will elucidate whether the disease process can be changed by using medical hypnosis with children to decrease pain, anxiety, and stress in the context of acute burn wounds.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12615000419561

Burd A, Yuen C. A global study of hospitalized paediatric burn patients. Burns. 2005;31(4):432–8. doi:10.1016/j.burns.2005.02.016.CrossRefPubMed

United States Centers for Disease Control and Prevention. Burns Safety: The Reality. CDC, Atlanta, USA. 2012. http://www.cdc.gov/safechild/Burns/index.html. Accessed 26 Apr 2016.

Australian Institute of Health and Welfare. A picture of Australia’s children 2012. Cat. no. PHE 167. Canberra: AIHW; 2012.

Pruitt Jr B, Wolf S, Mason Jr A. Epidemiological, demographic, and outcome characteristics of burn injury. In: Herndon D, editor. Total burn care. 4th ed. New York: Saunders Elsevier Inc.; 2012.

Lipman AG. Pain as a human right: the 2004 Global Day Against Pain. J Pain Palliat Care Pharmacother. 2005;19(3):85–100.PubMed

Brown NJ, Kimble RM, Rodger S, Ware RS, Cuttle L. Play and heal: randomized controlled trial of Ditto™ intervention efficacy on improving re-epithelialization in pediatric burns. Burns. 2014;40(2):204–13. doi:10.1016/j.burns.2013.11.024.CrossRefPubMed

Patterson DR, Ptacek JT. Baseline pain as a moderator of hypnotic analgesia for burn injury treatment. J Consult Clin Psychol. 1997;65(1):60–7.CrossRefPubMed

Bakker A, Maertens KJ, Van Son MJ, Van Loey NE. Psychological consequences of pediatric burns from a child and family perspective: a review of the empirical literature. Clin Psychol Rev. 2013;33(3):361–71. doi:10.1016/j.cpr.2012.12.006.CrossRefPubMed

Meyer WJ, Blakeney P, Thomas CR, Russell W, Robert RS, Holzer CE. Prevalence of major psychiatric illness in young adults who were burned as children. Psychosom Med. 2007;69(4):377–82. doi:10.1097/PSY.0b013e3180600a2e.CrossRefPubMed

10.

Thomas CR, Blakeney P, Holzer 3rd CE, Meyer 3rd WJ. Psychiatric disorders in long-term adjustment of at-risk adolescent burn survivors. J Burn Care Res. 2009;30(3):458–63. doi:10.1097/BCR.0b013e3181a28c36.CrossRefPubMed

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(1):56–63. doi:10.1111/j.1469-7610.2011.02431.x.CrossRefPubMed

12.

Stoddard FJ, Sheridan RL, Saxe GN, King BS, King BH, Chedekel DS, et al. Treatment of pain in acutely burned children. J Burn Care Rehabil. 2002;23(2):135–56.CrossRefPubMed

13.

Kuttner L. A child in pain: what health professionals can do to help. Bethel, CT: Crown House Publishing Company LLC; 2010.

14.

Sliwinski J, Fisher W, Johnson A, Elkins G. Medical hypnosis for pain and psychological distress during burn wound debridement: a critical review. OA Altern Med. 2013;1(1):5.CrossRef

15.

Widgerow AD, Kalaria S. Pain mediators and wound healing—establishing the connection. Burns. 2012;38(7):951–9. doi:10.1016/j.burns.2012.05.024.CrossRefPubMed

16.

Kumar V, Abbas AK, Aster JC. Robbins & Cotran pathologic basis of disease. 9th ed. Philadelphia, PA: Elsevier; 2015.

17.

Norbury WB, Herndon DN, Branski LK, Chinkes DL, Jeschke MG. Urinary cortisol and catecholamine excretion after burn injury in children. J Clin Endocrinol Metab. 2008;93(4):1270–5. doi:10.1210/jc.2006-2158.CrossRefPubMedPubMedCentral

18.

Kulp GA, Herndon DN, Lee JO, Suman OE, Jeschke MG. Extent and magnitude of catecholamine surge in pediatric burned patients. Shock. 2010;33(4):369–74. doi:10.1097/SHK.0b013e3181b92340.CrossRefPubMedPubMedCentral

19.

Christian LM, Graham JE, Padgett DA, Glaser R, Kiecolt-Glaser JK. Stress and wound healing. Neuroimmunomodulation. 2006;13(5–6):337–46. doi:10.1159/000104862.CrossRefPubMedPubMedCentral

20.

Vileikyte L. Stress and wound healing. Clin Dermatol. 2007;25(1):49–55. doi:10.1016/j.clindermatol.2006.09.005.CrossRefPubMed

21.

Walburn J, Vedhara K, Hankins M, Rixon L, Weinman J. Psychological stress and wound healing in humans: a systematic review and meta-analysis. J Psychosom Res. 2009;67(3):253–71. doi:10.1016/j.jpsychores.2009.04.002.CrossRefPubMed

22.

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(4):299–304. doi:10.1097/AJP.0b013e318164d2cc.CrossRefPubMed

23.

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(5):650–7.CrossRefPubMed

24.

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(5):647–58.CrossRefPubMed

25.

Brown NJ, Kimble RM, Gramotnev G, Rodger S, Cuttle L. Predictors of re-epithelialization in pediatric burn. Burns. 2014;40(4):751–8.CrossRefPubMed

26.

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(3):395–405. doi:10.1016/j.burns.2010.12.008.CrossRefPubMed

27.

Iserson KV. An hypnotic suggestion: review of hypnosis for clinical emergency care. J Emerg Med. 2014;46(4):588–96. doi:10.1016/j.jemermed.2013.09.024.CrossRefPubMed

28.

Ewin DM. The use of hypnosis in the treatment of burn patients. Psychiatr Med. 1992;10(4):79–87.PubMed

29.

Kohen DP, Olness KN. Hypnosis and hypnotherapy with children. 4th ed. New York, NY: Routledge Publications; 2011.

30.

Evans S, Tsao JC, Zeltzer LK. Complementary and alternative medicine for acute procedural pain in children. Altern Ther Health Med. 2008;14(5):52–6.PubMed

31.

Smith JT, Barabasz A, Barabasz M. Comparison of hypnosis and distraction in severely ill children undergoing painful medical procedures. J Couns Psychol. 1996;43(2):187–95. doi:10.1037/0022-0167.43.2.187.CrossRef

32.

Accardi MC, Milling LS. The effectiveness of hypnosis for reducing procedure-related pain in children and adolescents: a comprehensive methodological review. J Behav Med. 2009;32(4):328–39. doi:10.1007/s10865-009-9207-6.CrossRefPubMed

33.

Amini Harandi A, Esfandani A, Shakibaei F. The effect of hypnotherapy on procedural pain and state anxiety related to physiotherapy in women hospitalized in a burn unit. Contemp Hypn. 2004;21(1):28–34.CrossRef

34.

Askay SW, Patterson DR, Jensen MP, Sharar SR. A randomized controlled trial of hypnosis for burn wound care. Rehabil Psychol. 2007;52(3):247–53.CrossRef

35.

Berger MM, Davadant M, Marin C, Wasserfallen JB, Pinget C, Maravic P, et al. Impact of a pain protocol including hypnosis in major burns. Burns. 2010;36(5):639–46. doi:10.1016/j.burns.2009.08.009.CrossRefPubMed

36.

Abdeshahi SK, Hashemipour MA, Mesgarzadeh V, Shahidi Payam A, Halaj MA. Effect of hypnosis on induction of local anaesthesia, pain perception, control of haemorrhage and anxiety during extraction of third molars: a case-control study. J Craniomaxillofac Surg. 2013;41(4):310–5. doi:10.1016/j.jcms.2012.10.009.CrossRefPubMed

37.

Snow A, Dorfman D, Warbet R, Cammarata M, Eisenman S, Zilberfein F, et al. A randomized trial of hypnosis for relief of pain and anxiety in adult cancer patients undergoing bone marrow procedures. J Psychosoc Oncol. 2012;30(3):281–93. doi:10.1080/07347332.2012.664261.CrossRefPubMed

38.

Elkins G, White J, Patel P, Marcus J, Perfect MM, Montgomery GH. Hypnosis to manage anxiety and pain associated with colonoscopy for colorectal cancer screening: case studies and possible benefits. Int J Clin Exp Hypn. 2006;54(4):416–31. doi:10.1080/00207140600856780.CrossRefPubMed

39.

Rogovik AL, Goldman RD. Hypnosis for treatment of pain in children. Can Fam Physician. 2007;53(5):823–5.PubMedPubMedCentral

40.

Foertsch CE, O'Hara MW, Stoddard FJ, Kealey GP. Treatment-resistant pain and distress during pediatric burn-dressing changes. J Burn Care Rehabil. 1998;19(3):219–24.CrossRefPubMed

41.

Hammond DC. Hypnotic Induction & Suggestion. Revised ed. Chicago, IL: American Society of Clinical Hypnosis; 1998.

42.

Kuttner L. Pediatric hypnosis: pre-, peri-, and post-anesthesia. Paediatr Anaesth. 2012;22(6):573–7. doi:10.1111/j.1460-9592.2012.03860.x.CrossRefPubMed

43.

Schulz K, Altman D, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11(1):32.CrossRefPubMedPubMedCentral

44.

Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. doi:10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMed

45.

Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi:10.1136/bmj.g1687.CrossRefPubMed

46.

Wiechman Askay S, Patterson DR. Hypnotic analgesia. Expert Rev Neurother. 2007;7(12):1675–83. doi:10.1586/14737175.7.12.1675.CrossRefPubMed

47.

Kuttner L. Favorite stories: a hypnotic pain-reduction technique for children in acute pain. Am J Clin Hypn. 1988;30(4):289–95. doi:10.1080/00029157.1988.10402752.CrossRefPubMed

48.

Cyna AM, Tomkins D, Maddock T, Barker D. Brief hypnosis for severe needle phobia using switch-wire imagery in a 5-year old. Paediatr Anaesth. 2007;17(8):800–4. doi:10.1111/j.1460-9592.2007.02224.x.CrossRefPubMed

49.

Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001;93(2):173–83.CrossRefPubMed

50.

Merkel S, Voepel-Lewis T, Malviya S. Pain assessment in infants and young children: the FLACC scale. Am J Nurs. 2002;102(10):55–8.CrossRef

51.

Crellin DJ, Harrison D, Santamaria N, Babl FE. Systematic Review of the FLACC scale for assessing pain in infants and children: is it reliable, valid, and feasible for use? Pain. 2015. doi:10.1097/j.pain.0000000000000305.PubMed

52.

Khin Hla T, Hegarty M, Russell P, Drake-Brockman TF, Ramgolam A, von Ungern-Sternberg BS. Perception of Pediatric Pain: a comparison of postoperative pain assessments between child, parent, nurse, and independent observer. Paediatr Anaesth. 2014;24(11):1127–31. doi:10.1111/pan.12484.CrossRefPubMed

53.

McBride CA, Kimble RM, Stockton K. Three donor site dressings in pediatric split-thickness skin grafts: study protocol for a randomised controlled trial. Trials. 2015;16(1):43. doi:10.1186/s13063-015-0557-9.CrossRefPubMedPubMedCentral

54.

Stockton KA, McMillan CM, Storey KJ, David MC, Kimble RM. 3D photography is as accurate as digital planimetry tracing in determining burn wound area. Burns. 2015;41(1):80–4. doi:10.1016/j.burns.2014.04.022.CrossRefPubMed

55.

Choiniere M, Melzack R, Rondeau J, Girard N, Paquin MJ. The pain of burns: characteristics and correlates. J Trauma. 1989;29(11):1531–9.CrossRefPubMed

56.

McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, et al. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008;9(9):771–83. doi:10.1016/j.jpain.2008.04.007.CrossRefPubMed

57.

Foa EB, Johnson KM, Feeny NC, Treadwell KR. The child PTSD Symptom Scale: a preliminary examination of its psychometric properties. J Clin Child Psychol. 2001;30(3):376–84. doi:10.1207/s15374424jccp3003_9.CrossRefPubMed

58.

Scheeringa MS. Young Child PTSD Checklist. New Orleans, USA: Tulane University; 2013.

59.

Scheeringa MS, Myers L, Putnam FW, Zeanah CH. Diagnosing PTSD in early childhood: an empirical assessment of four approaches. J Trauma Stress. 2012;25(4):359–67. doi:10.1002/jts.21723.CrossRefPubMed

60.

Scheeringa MS, Peebles CD, Cook CA, Zeanah CH. Toward establishing procedural, criterion, and discriminant validity for PTSD in early childhood. J Am Acad Child Adolesc Psychiatry. 2001;40(1):52–60. doi:10.1097/00004583-200101000-00016.CrossRefPubMed

61.

Scheeringa MS, Zeanah CH, Drell MJ, Larrieu JA. Two approaches to the diagnosis of posttraumatic stress disorder in infancy and early childhood. J Am Acad Child Adolesc Psychiatry. 1995;34(2):191–200. doi:10.1097/00004583-199502000-00014.CrossRefPubMed

62.

Scheeringa MS, Zeanah CH, Myers L, Putnam FW. New findings on alternative criteria for PTSD in preschool children. J Am Acad Child Adolesc Psychiatry. 2003;42(5):561–70. doi:10.1097/01.chi.0000046822.95464.14.CrossRefPubMed

63.

Scheeringa MS, Haslett N. The reliability and criterion validity of the Diagnostic Infant and Preschool Assessment: a new diagnostic instrument for young children. Child Psychiatry Hum Dev. 2010;41(3):299–312. doi:10.1007/s10578-009-0169-2.CrossRefPubMedPubMedCentral

64.

Scheeringa MS, Zeanah CH, Myers L, Putnam FW. Predictive validity in a prospective follow-up of PTSD in preschool children. J Am Acad Child Adolesc Psychiatry. 2005;44(9):899–906. doi:10.1097/01.chi.0000169013.81536.71.CrossRefPubMed

65.

Bali A, Jaggi AS. Clinical experimental stress studies: methods and assessment. Rev Neurosci. 2015. doi:10.1515/revneuro-2015-0004.

66.

Morgan AH, Hilgard JR. The Stanford Hypnotic Clinical Scale for children. Am J Clin Hypn. 1978;21(2–3):148–69.CrossRefPubMed

67.

Lund CC, Browder NC. The estimation of areas of burns. Surg Gyn Obstet. 1944;79:352–8.

68.

Gee Kee EL, Kimble RM, Cuttle L, Khan A, Stockton KA. Randomized controlled trial of three burns dressings for partial thickness burns in children. Burns. 2015;41(5):946–55. doi:10.1016/j.burns.2014.11.005.CrossRefPubMed

69.

Brown NJ, Rodger S, Ware RS, Kimble RM, Cuttle L. 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. Trials. 2012;13:238. doi:10.1186/1745-6215-13-238.

70.

Šidák Z. Rectangular confidence regions for the means of multivariate normal distributions. J Am Stat Assoc. 1967;62(318):626–33. doi:10.1080/01621459.1967.10482935.

71.

Rainville P, Hofbauer RK, Paus T, Duncan GH, Bushnell MC, Price DD. Cerebral mechanisms of hypnotic induction and suggestion. J Cogn Neurosci. 1999;11(1):110–25.CrossRefPubMed

72.

Rainville P, Hofbauer RK, Bushnell MC, Duncan GH, Price DD. Hypnosis modulates activity in brain structures involved in the regulation of consciousness. J Cogn Neurosci. 2002;14(6):887–901. doi:10.1162/089892902760191117.CrossRefPubMed

73.

Faymonville ME, Laureys S, Degueldre C, DelFiore G, Luxen A, Franck G, et al. Neural mechanisms of antinociceptive effects of hypnosis. Anesthesiology. 2000;92(5):1257–67.CrossRefPubMed

74.

Faymonville ME, Roediger L, Del Fiore G, Delgueldre C, Phillips C, Lamy M, et al. Increased cerebral functional connectivity underlying the antinociceptive effects of hypnosis. Brain Res Cogn Brain Res. 2003;17(2):255–62.CrossRefPubMed

75.

Kupers R, Faymonville ME, Laureys S. The cognitive modulation of pain: hypnosis- and placebo-induced analgesia. Prog Brain Res. 2005;150:251–69. doi:10.1016/s0079-6123(05)50019-0.CrossRefPubMed

76.

Faymonville ME, Boly M, Laureys S. Functional neuroanatomy of the hypnotic state. J Physiol Paris. 2006;99(4–6):463–9. doi:10.1016/j.jphysparis.2006.03.018.CrossRefPubMed

77.

Vanhaudenhuyse A, Boly M, Balteau E, Schnakers C, Moonen G, Luxen A, et al. Pain and non-pain processing during hypnosis: a thulium-YAG event-related fMRI study. Neuroimage. 2009;47(3):1047–54. doi:10.1016/j.neuroimage.2009.05.031.CrossRefPubMed

78.

Vanhaudenhuyse A, Laureys S, Faymonville ME. Neurophysiology of hypnosis. Clin Neurophysiol. 2014;44(4):343–53. doi:10.1016/j.neucli.2013.09.006.CrossRef

79.

Wood C, Bioy A. Hypnosis and pain in children. J Pain Symptom Manage. 2008;35(4):437–46. doi:10.1016/j.jpainsymman.2007.05.009.CrossRefPubMed

80.

Barber J. Hypnotic analgesia: mechanisms of action and clinical applications. In: Price DD, Bushnell C, editors. Psychological methods of pain control: basic science and clinical perspectives. Progress in pain research and management, vol. 29. Seattle, WA: IASP Press; 2004. p. 269–294.

81.

Calipel S, Lucas-Polomeni MM, Wodey E, Ecoffey C. Premedication in children: hypnosis versus midazolam. Paediatr Anaesth. 2005;15(4):275–81. doi:10.1111/j.1460-9592.2004.01514.x.CrossRefPubMed

82.

Patterson DR, Jensen MP. Hypnosis and clinical pain. Psychol Bull. 2003;129(4):495–521.CrossRefPubMed

Title: Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial
Authors: Stephen J. Chester
Kellie Stockton
Alexandra De Young
Belinda Kipping
Zephanie Tyack
Bronwyn Griffin
Ralph L. Chester
Roy M. Kimble
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-016-1346-9

At a glance: The STEP trials

Springer Medicine

Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial

Abstract

Background

Methods/Design

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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