Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Status: Unknown

Conditions: Pain

Treatments: Drug: Conventional treatment; Other: Accompaniment without causing the laughter of children.; Other: Laughter therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02563587

HGNAE-02

pecm830703 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups, including a placebo group

Group LT-CT

Experimental group

Description:

Laughter therapy with conventional treatment

Treatment:

Other: Laughter therapy

Group AW-CT

Placebo Comparator group

Description:

Accompaniment without causing the laughter of children more conventional treatment

Treatment:

Other: Accompaniment without causing the laughter of children.

Group CT

Sham Comparator group

Description:

Conventional treatment only

Treatment:

Drug: Conventional treatment