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Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563587
Recruitment Status : Unknown
Verified September 2015 by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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.

Condition or disease Intervention/treatment Phase
Pain Other: Laughter therapy Other: Accompaniment without causing the laughter of children. Drug: Conventional treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy of the Spontaneous Laughter on Postoperative Pain and Anxiety in Children. A Randomized Controlled Trial
Study Start Date : September 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Group LT-CT
Laughter therapy with conventional treatment
Other: 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.
Other Name: Group LT-CT

Placebo Comparator: Group AW-CT
Accompaniment without causing the laughter of children more conventional treatment
Other: 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.
Other Name: Group AW-CT

Sham Comparator: Group CT
Conventional treatment only
Drug: 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 Name: Group CT




Primary Outcome Measures :
  1. Postoperative pain level [ Time Frame: 48 hours after surgery ]
    Pain level measurement at 48 hours determined by the visual analogue scale (Range: 0-10 cm)


Secondary Outcome Measures :
  1. Postoperative anxiety level [ Time Frame: 48 hours after surgery ]
    Postoperative anxiety level determined by STAIC (State Trait Anxiety Inventory Children) (Range: 10-40 points)

  2. Postoperative urinary cortisol level [ Time Frame: 48 hours after surgery ]
    Postoperative stress level determined by urinary cortisol (μg/dl)

  3. Postoperative heart rate [ Time Frame: 48 hours after surgery ]
    Postoperative heart rate (beat per minute)

  4. Postoperative respiratory rates [ Time Frame: 48 hours after surgery ]
    Postoperative breathing frequency (breath per minute)

  5. Postoperative systolic blood pressure [ Time Frame: 48 hours after surgery ]
    Postoperative systolic blood pressure (mmHg)

  6. Postoperative diastolic blood pressure [ Time Frame: 48 hours after surgery ]
    Postoperative diastolic blood pressure (mmHg)

  7. Postoperative oxygen saturation [ Time Frame: 48 hours after surgery ]
    Postoperative oxygen saturation (%)

  8. Length of hospital stay [ Time Frame: 168 hours after surgery ]
    Postoperative hospital stay length (hours)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563587


Contacts
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Contact: Magda Ruth Pérez Cervantes, Pediatrician (52)5550371200 ext 5423 dagmacancer@yahoo.com

Locations
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Mexico
Hospital General Naval de Alta Especialidad Recruiting
México, Distrito Federal, Distrito Federal, Mexico, 04480
Contact: Magda Ruth Pérez Cervantes, Pediatrician    (52)5550371200 ext 5423    dagmacancer@yahoo.com   
Sponsors and Collaborators
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Investigators
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Principal Investigator: Magda Ruth Pérez Cervantes, Pediatrician Secretaria de Marina
Publications of Results:
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
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
Guyton y Hall. Tratado de Fisiología médica. Editorial ELSEVIER. 2011; 12: 1052-1055
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
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
Lancheros GE, Tovar VJ, Rojas BC. Laughter and health: therapeutic approaches. Med UNAB. 2011 jul; 14(1): 69-75
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

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Responsible Party: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
ClinicalTrials.gov Identifier: NCT02563587    
Other Study ID Numbers: HGNAE-02
pecm830703 ( Registry Identifier: Magda Ruth Pérez Cervantes )
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Keywords provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval:
Laughter
children
postoperative
pain
anxiety
cortisol