Pain Clinical Trial
Official title:
Efficacy of the Spontaneous Laughter on Postoperative Pain and Anxiety in Children. A Randomized Controlled Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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