Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children

Not Applicable

• Conditions: Pain
• Interventions: Other: Laughter therapy; Drug: Conventional treatment; Other: Accompaniment without causing the laughter of children.

• Registration Number: NCT02563587
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-09
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-28
• Last Update Submitted: 2015-09-28
• Study First Posted: 2015-09-30
• Last Update Posted: 2015-09-30
• Primary Completion: 2016-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group LT-CT	Laughter therapy	Laughter therapy with conventional treatment
Group CT	Conventional treatment	Conventional treatment only
Group AW-CT	Accompaniment without causing the laughter of children.	Accompaniment without causing the laughter of children more conventional treatment

Primary Outcome Measures

Name	Time	Method
Postoperative pain level	48 hours after surgery	Pain level measurement at 48 hours determined by the visual analogue scale (Range: 0-10 cm)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital General Naval de Alta Especialidad; 🇲🇽 México, Distrito Federal, Distrito Federal, Mexico