Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Other: Laughter therapy
* Other: Accompaniment without causing the laughter of children.
* Drug: Conventional treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group LT-CT<br>Laughter therapy with conventional treatment | Other: Laughter therapy<br>* 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.<br>* Other names: Group LT-CT;|
| Placebo Comparator: Group AW-CT<br>Accompaniment without causing the laughter of children more conventional treatment | Other: Accompaniment without causing the laughter of children.<br>* 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.<br>* Other names: Group AW-CT;|
| Sham Comparator: Group CT<br>Conventional treatment only | Drug: Conventional treatment<br>* 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.<br>* Other names: Group CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain level | Pain level measurement at 48 hours determined by the visual analogue scale (Range: 0-10 cm) | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative anxiety level | Postoperative anxiety level determined by STAIC (State Trait Anxiety Inventory Children) (Range: 10-40 points) | 48 hours after surgery | 
| Postoperative urinary cortisol level | Postoperative stress level determined by urinary cortisol (μg/dl) | 48 hours after surgery | 
| Postoperative heart rate | Postoperative heart rate (beat per minute) | 48 hours after surgery | 
| Postoperative respiratory rates | Postoperative breathing frequency (breath per minute) | 48 hours after surgery | 
| Postoperative systolic blood pressure | Postoperative systolic blood pressure (mmHg) | 48 hours after surgery | 
| Postoperative diastolic blood pressure | Postoperative diastolic blood pressure (mmHg) | 48 hours after surgery | 
| Postoperative oxygen saturation | Postoperative oxygen saturation (%) | 48 hours after surgery | 
| Length of hospital stay | Postoperative hospital stay length (hours) | 168 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laughter, children, postoperative, pain, anxiety, cortisol