Clinical trial NCT02563587: Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children
Official title: Efficacy of the Spontaneous Laughter on Postoperative Pain and Anxiety in Children. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Laughter
children
postoperative
pain
anxiety
cortisol
Lead sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Sponsor class: OTHER_GOV
First posted: 2015-09-30
Enrollment: 210
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the efficacy of laughter therapy in children to improve postoperative, evaluating the intensity of postoperative pain, anxiety and hospital stay.

Detailed description: The therapeutic efficacy of laughter is supported in several research which have shown to have preventive and therapeutic effects that contribute to a better quality of life. In addition, laughter can optimize strategies to increase pain tolerance and combat stress, reducing the negative impact such as increased blood pressure, decreases simultaneously perfusion of organs not needed for the motor function, increased metabolism rates cell with increased serum cortisol and increased risk of infections. Nevertheless the upswing in research on these effects, there is still a necessity to have evidence-based medicine as most of the available studies are limited by various problems such as lack of objectivity in the assessment and measurement, distinction between laughter and mood, establishment dosing therapies (frequency and time).

The aim of our study is to determine the efficacy of spontaneous laughter in children to improve postoperative pain, anxiety and length of hospital stay.

Methods: A controlled, randomized, open label trial with an experimental group exposed to the conventional pain treatment with laughter therapy; 2 control group, a group with accompaniment without causing the laughter of children to control the effect of a companion instead of the clown and a conventional treatment group to contrast with experimental group.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients between 6 and 14
* I hospitalized with uncomplicated surgical procedure
* Minimum period of hospitalization of 48 hours
* Patients with informed consent letter signed by parents or guardians
* In patients older than 10 years, a letter of agreement

Exclusion Criteria:

* Endocrinopathies carriers, cancer, abnormalities of central nervous system immune disorders patients.
* Patients treated with both topical and systemic steroids

Primary outcomes:
measure: Postoperative pain level
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Postoperative anxiety level
timeFrame: 48 hours after surgery
measure: Postoperative urinary cortisol level
timeFrame: 48 hours after surgery
measure: Postoperative heart rate
timeFrame: 48 hours after surgery
measure: Postoperative respiratory rates
timeFrame: 48 hours after surgery
measure: Postoperative systolic blood pressure
timeFrame: 48 hours after surgery
measure: Postoperative diastolic blood pressure
timeFrame: 48 hours after surgery
measure: Postoperative oxygen saturation
timeFrame: 48 hours after surgery
measure: Length of hospital stay
timeFrame: 168 hours after surgery
Other outcomes:
Locations:
city: México, Distrito Federal
country: Mexico
facility: Hospital General Naval de Alta Especialidad
state: Distrito Federal
Study officials:
affiliation: Secretaria de Marina
name: Magda Ruth Pérez Cervantes, Pediatrician
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guzmán SV, Torres HJ, Plascencia HA, Castellanos MJ, Quintanilla MR. Cultura hospitalaria y el proceso narrativo en el niño enfermo. Estudio sobre las Culturas Contemporáneas. 2011 jul; XVII (33): 23-44
citation: González ML, Gallardo DE. Calidad de la atención médica: La diferencia entre la vida o la muerte. Revista digital universitaria UNAM. 2012 Ago; 13 (8)
citation: Hernandez PE, Rabadan RJ. Hospitalization, a break in the child´s life. Educational attention in infantile hospitalized population. Perspectiva Educacional. 2013 Ene; 52 (1):167-181
citation: Meisel V, Chellew K, Ponsell E, Ferreira A, Bordas L, Garcia-Banda G. [The effect of "hospital clowns" on distress and maladaptive behaviours of children who are undergoing minor surgery]. Psicothema. 2009 Nov;21(4):604-9. Spanish.
citation: Griffin GD, Charron D, Al-Daccak R. Post-traumatic stress disorder: revisiting adrenergics, glucocorticoids, immune system effects and homeostasis. Clin Transl Immunology. 2014 Nov 14;3(11):e27. doi: 10.1038/cti.2014.26. eCollection 2014 Nov.
citation: Guyton y Hall. Tratado de Fisiología médica. Editorial ELSEVIER. 2011; 12: 1052-1055
citation: Heden LE, von Essen L, Ljungman G. Effect of morphine in needle procedures in children with cancer. Eur J Pain. 2011 Nov;15(10):1056-60. doi: 10.1016/j.ejpain.2011.05.010. Epub 2011 Jun 15.
citation: Brasher C, Gafsous B, Dugue S, Thiollier A, Kinderf J, Nivoche Y, Grace R, Dahmani S. Postoperative pain management in children and infants: an update. Paediatr Drugs. 2014 Apr;16(2):129-40. doi: 10.1007/s40272-013-0062-0.
citation: Montero-Homs J. [Nocioceptive pain, neuropathic pain and pain memory]. Neurologia. 2009 Jul-Aug;24(6):419-22. Spanish.
citation: Finley GA, Kristjansdottir O, Forgeron PA. Cultural influences on the assessment of children's pain. Pain Res Manag. 2009 Jan-Feb;14(1):33-7. doi: 10.1155/2009/763031.
citation: Noel M, Chambers CT, McGrath PJ, Klein RM, Stewart SH. The role of state anxiety in children's memories for pain. J Pediatr Psychol. 2012 Jun;37(5):567-79. doi: 10.1093/jpepsy/jss006. Epub 2012 Feb 23.
citation: Christian R, Ramos J, Susanibar C, Balarezo G. Laugh Therapy: A new field for healthcare professionals. Rev. Soc. Per. Med. Inter. 2004; 17(2)
citation: Gendry S. Certified Laughter Yoga Teacher Workbook. American School of Laughter Yoga. 2013
citation: Nasr SJ. No laughing matter: laughter is good psychiatric medicine. A case report. Current Psychiatry. 2013; 12(8): 20-25
citation: Amez AJ, Díaz PM. Manejo del dolor en odontopediatría. Rev Estomatol Herediana. 2010; 20(3):166-171
citation: Takeda M, Hashimoto R, Kudo T, Okochi M, Tagami S, Morihara T, Sadick G, Tanaka T. Laughter and humor as complementary and alternative medicines for dementia patients. BMC Complement Altern Med. 2010 Jun 18;10:28. doi: 10.1186/1472-6882-10-28.
citation: Woodbury-Farina MA, Antongiorgi JL. Humor. Psychiatr Clin North Am. 2014 Dec;37(4):561-78. doi: 10.1016/j.psc.2014.08.006. Epub 2014 Nov 25.
citation: Pearce JM. Some neurological aspects of laughter. Eur Neurol. 2004;52(3):169-71. doi: 10.1159/000081857. Epub 2004 Nov 2.
citation: Rodríguez AC, Magallanes MA, Estañol VB, Tovar VJ, Valencia FM. Aspectos neurológicos y neurofisiología de la risa. Arch Neurocien INNN. 2000; 5(1): 43-49
citation: Lancheros GE, Tovar VJ, Rojas BC. Laughter and health: therapeutic approaches. Med UNAB. 2011 jul; 14(1): 69-75
citation: Kimata H. Effect of humor on allergen-induced wheal reactions. JAMA. 2001 Feb 14;285(6):738. doi: 10.1001/jama.285.6.738. No abstract available.
citation: Mora Ripoll R, Garcia Rodera MC. [Therapeutical value of laughter in medicine]. Med Clin (Barc). 2008 Nov 22;131(18):694-8. doi: 10.1157/13129114. No abstract available. Spanish.
citation: Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.
citation: Bennett MP, Zeller JM, Rosenberg L, McCann J. The effect of mirthful laughter on stress and natural killer cell activity. Altern Ther Health Med. 2003 Mar-Apr;9(2):38-45.
citation: Mifflin KA, Hackmann T, Chorney JM. Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1162-7. doi: 10.1213/ANE.0b013e31824d5224. Epub 2012 Oct 9.
citation: Yip P, Middleton P, Cyna AM, Carlyle AV. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006447. doi: 10.1002/14651858.CD006447.pub2.
citation: Fernandes SC, Arriaga P. The effects of clown intervention on worries and emotional responses in children undergoing surgery. J Health Psychol. 2010 Apr;15(3):405-15. doi: 10.1177/1359105309350231.
citation: Chang C, Tsai G, Hsieh CJ. Psychological, immunological and physiological effects of a Laughing Qigong Program (LQP) on adolescents. Complement Ther Med. 2013 Dec;21(6):660-8. doi: 10.1016/j.ctim.2013.09.004. Epub 2013 Sep 13.
citation: Villamil M, Quintero A, Henao E, Cardona JL. Terapia de la risa en un grupo de mujeres adultas. Rev. Fac. Nac. Salud Pública 2013;31(2):202-208
citation: Sakai Y, Takayanagi K, Ohno M, Inose R, Fujiwara H. A trial of improvement of immunity in cancer patients by laughter therapy. Jpn Hosp. 2013 Jul;(32):53-9.