Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children
NCT ID: NCT02563587
Last Updated: 2015-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
210 participants
INTERVENTIONAL
2015-09-30
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group LT-CT
Laughter therapy with conventional treatment
Laughter therapy
Laughter therapy sessions will begin as soon as / after that the complete anesthesia recovery, then we could start with two interventions, each of them in morning and during the afternoon will be held until their discharge lasting 30 minutes per each one, these sessions will be held in the service pediatric hospital by trained personnel in laughter therapy, which will be implemented through hospital clowns.
Group AW-CT
Accompaniment without causing the laughter of children more conventional treatment
Accompaniment without causing the laughter of children.
The interventions will be carried out by means of reading stories and own stories for the age. These sessions will begin subsequent to the full recovery of the anesthesia, and then two interventions per day, in the morning and evening, with duration of 30 minutes, until the time of his discharge, these sessions will take place in the service of Hospital pediatrics by the resident in charge.
Group CT
Conventional treatment only
Conventional treatment
Conventional treatment involves handling analgesic with non-steroidal anti-inflammatory drugs (paracetaol, metamizol and ketorolac) as prescribed by the doctor surgeon treating, which starts immediately in the postoperative period.
Interventions
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Laughter therapy
Laughter therapy sessions will begin as soon as / after that the complete anesthesia recovery, then we could start with two interventions, each of them in morning and during the afternoon will be held until their discharge lasting 30 minutes per each one, these sessions will be held in the service pediatric hospital by trained personnel in laughter therapy, which will be implemented through hospital clowns.
Accompaniment without causing the laughter of children.
The interventions will be carried out by means of reading stories and own stories for the age. These sessions will begin subsequent to the full recovery of the anesthesia, and then two interventions per day, in the morning and evening, with duration of 30 minutes, until the time of his discharge, these sessions will take place in the service of Hospital pediatrics by the resident in charge.
Conventional treatment
Conventional treatment involves handling analgesic with non-steroidal anti-inflammatory drugs (paracetaol, metamizol and ketorolac) as prescribed by the doctor surgeon treating, which starts immediately in the postoperative period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients treated with both topical and systemic steroids
6 Years
14 Years
ALL
No
Sponsors
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Hospital General Naval de Alta Especialidad - Escuela Medico Naval
OTHER_GOV
Responsible Party
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Principal Investigators
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Magda Ruth Pérez Cervantes, Pediatrician
Role: PRINCIPAL_INVESTIGATOR
Secretaria de Marina
Locations
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Hospital General Naval de Alta Especialidad
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Magda Ruth Pérez Cervantes, Pediatrician
Role: CONTACT
Phone: (52)5550371200
Email: [email protected]
Facility Contacts
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Magda Ruth Pérez Cervantes, Pediatrician
Role: primary
References
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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)
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
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.
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.
Guyton y Hall. Tratado de Fisiología médica. Editorial ELSEVIER. 2011; 12: 1052-1055
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.
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.
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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.
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.
Christian R, Ramos J, Susanibar C, Balarezo G. Laugh Therapy: A new field for healthcare professionals. Rev. Soc. Per. Med. Inter. 2004; 17(2)
Gendry S. Certified Laughter Yoga Teacher Workbook. American School of Laughter Yoga. 2013
Nasr SJ. No laughing matter: laughter is good psychiatric medicine. A case report. Current Psychiatry. 2013; 12(8): 20-25
Amez AJ, Díaz PM. Manejo del dolor en odontopediatría. Rev Estomatol Herediana. 2010; 20(3):166-171
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.
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.
Pearce JM. Some neurological aspects of laughter. Eur Neurol. 2004;52(3):169-71. doi: 10.1159/000081857. Epub 2004 Nov 2.
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
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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.
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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.
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Other Identifiers
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pecm830703
Identifier Type: REGISTRY
Identifier Source: secondary_id
HGNAE-02
Identifier Type: -
Identifier Source: org_study_id