Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children

September 28, 2015 updated by: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Magda Ruth Pérez Cervantes, Pediatrician
  • Phone Number: 5423 (52)5550371200
  • Email: dagmacancer@yahoo.com

Study Locations

  • Mexico
    • Distrito Federal
      • México, Distrito Federal, Distrito Federal, Mexico, 04480
        • Recruiting
        • Hospital General Naval de Alta Especialidad
        • Contact:
          • Magda Ruth Pérez Cervantes, Pediatrician
          • Phone Number: 5423 (52)5550371200
          • Email: dagmacancer@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group LT-CT
Laughter therapy with conventional treatment
Other: Laughter 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.
Other Names:
  • Group LT-CT
Placebo Comparator: Group AW-CT
Accompaniment without causing the laughter of children more conventional treatment
Other: Accompaniment 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.
Other Names:
  • Group AW-CT
Sham Comparator: Group CT
Conventional treatment only
Drug: Conventional 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.
Other Names:
  • Group CT

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Investigators

  • Principal Investigator: Magda Ruth Pérez Cervantes, Pediatrician, Secretaria de Marina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HGNAE-02
  • pecm830703 (Registry Identifier: Magda Ruth Pérez Cervantes)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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