NCT02563587

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

September 11, 2015

Last Update Submit

September 28, 2015

Conditions

Pain

Keywords

Laughterchildrenpostoperativepainanxietycortisol

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain level

    Pain level measurement at 48 hours determined by the visual analogue scale (Range: 0-10 cm)

    48 hours after surgery

Secondary Outcomes (8)

  • Postoperative anxiety level

    48 hours after surgery

  • Postoperative urinary cortisol level

    48 hours after surgery

  • Postoperative heart rate

    48 hours after surgery

  • Postoperative respiratory rates

    48 hours after surgery

  • Postoperative systolic blood pressure

    48 hours after surgery

  • +3 more secondary outcomes

Study Arms (3)

Group LT-CT

EXPERIMENTAL

Laughter therapy with conventional treatment

Other: Laughter therapy

Group AW-CT

PLACEBO COMPARATOR

Accompaniment without causing the laughter of children more conventional treatment

Other: Accompaniment without causing the laughter of children.

Group CT

SHAM COMPARATOR

Conventional treatment only

Drug: Conventional treatment

Interventions

Laughter therapyOTHER

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.

Also known as: Group LT-CT
Group LT-CT
Accompaniment without causing the laughter of children.OTHER

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.

Also known as: Group AW-CT
Group AW-CT
Conventional treatmentDRUG

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.

Also known as: Group CT
Group CT

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Naval de Alta Especialidad

Mexico City, Mexico City, 04480, Mexico

RECRUITING

Related Publications (30)

  • 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

    RESULT

  • 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)

    RESULT

  • 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

    RESULT

  • 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.

    PMID: 19861106RESULT

  • 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.

    PMID: 25505957RESULT

  • Guyton y Hall. Tratado de Fisiología médica. Editorial ELSEVIER. 2011; 12: 1052-1055

    RESULT

  • 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.

    PMID: 21680210RESULT

  • 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.

    PMID: 24407716RESULT

  • Montero-Homs J. [Nocioceptive pain, neuropathic pain and pain memory]. Neurologia. 2009 Jul-Aug;24(6):419-22. Spanish.

    PMID: 19798608RESULT

  • 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.

    PMID: 19262914RESULT

  • 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.

    PMID: 22362922RESULT

  • Christian R, Ramos J, Susanibar C, Balarezo G. Laugh Therapy: A new field for healthcare professionals. Rev. Soc. Per. Med. Inter. 2004; 17(2)

    RESULT

  • Gendry S. Certified Laughter Yoga Teacher Workbook. American School of Laughter Yoga. 2013

    RESULT

  • Nasr SJ. No laughing matter: laughter is good psychiatric medicine. A case report. Current Psychiatry. 2013; 12(8): 20-25

    RESULT

  • Amez AJ, Díaz PM. Manejo del dolor en odontopediatría. Rev Estomatol Herediana. 2010; 20(3):166-171

    RESULT

  • 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.

    PMID: 20565815RESULT

  • 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.

    PMID: 25455066RESULT

  • Pearce JM. Some neurological aspects of laughter. Eur Neurol. 2004;52(3):169-71. doi: 10.1159/000081857. Epub 2004 Nov 2.

    PMID: 15528918RESULT

  • 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

    RESULT

  • Lancheros GE, Tovar VJ, Rojas BC. Laughter and health: therapeutic approaches. Med UNAB. 2011 jul; 14(1): 69-75

    RESULT

  • 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.

    PMID: 11176910RESULT

  • 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.

    PMID: 19087828RESULT

  • 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.

    PMID: 16199685RESULT

  • 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.

    PMID: 12652882RESULT

  • 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.

    PMID: 23051880RESULT

  • 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.

    PMID: 19588390RESULT

  • 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.

    PMID: 20348361RESULT

  • 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.

    PMID: 24280475RESULT

  • 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

    RESULT

  • 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.

    PMID: 23984543RESULT

MeSH Terms

Conditions

PainLaughterAnxiety Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNonverbal CommunicationCommunicationBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Magda Ruth Pérez Cervantes, Pediatrician

    Secretaria de Marina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magda Ruth Pérez Cervantes, Pediatrician

CONTACT

(52)5550371200dagmacancer@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 30, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2018

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

ME(1)