NCT02563587

Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children

Efficacy of the Spontaneous Laughter on Postoperative Pain and Anxiety in Children. A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval · Other Government
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
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	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.
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-01-01
• Completion: 2018-01-01
• First posted: 2015-09-30
• Last updated: 2015-09-30

Locations

1 site across 1 country: Mexico