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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02563587
Enrollment
210
Registered
2015-09-30
Start date
2015-09-30
Completion date
2018-01-31
Last updated
2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Laughter, children, postoperative, pain, anxiety, cortisol

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.

Interventions

OTHERLaughter 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.

OTHERAccompaniment 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.

DRUGConventional 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.

Sponsors

Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain level48 hours after surgeryPain level measurement at 48 hours determined by the visual analogue scale (Range: 0-10 cm)

Secondary

MeasureTime frameDescription
Postoperative urinary cortisol level48 hours after surgeryPostoperative stress level determined by urinary cortisol (μg/dl)
Postoperative heart rate48 hours after surgeryPostoperative heart rate (beat per minute)
Postoperative respiratory rates48 hours after surgeryPostoperative breathing frequency (breath per minute)
Postoperative anxiety level48 hours after surgeryPostoperative anxiety level determined by STAIC (State Trait Anxiety Inventory Children) (Range: 10-40 points)
Postoperative diastolic blood pressure48 hours after surgeryPostoperative diastolic blood pressure (mmHg)
Postoperative oxygen saturation48 hours after surgeryPostoperative oxygen saturation (%)
Length of hospital stay168 hours after surgeryPostoperative hospital stay length (hours)
Postoperative systolic blood pressure48 hours after surgeryPostoperative systolic blood pressure (mmHg)

Countries

Mexico

Contacts

Primary ContactMagda Ruth Pérez Cervantes, Pediatrician
dagmacancer@yahoo.com(52)5550371200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026