Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02563587
• Other study ID #: HGNAE-02
• Secondary ID: pecm830703
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2015
• Last updated: September 28, 2015
• Start date: September 2015
• Est. completion date: January 2018

Study information

• Verified date: September 2015
• Source: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
• Contact: Magda Ruth Pérez Cervantes, Pediatrician
• Phone: (52)5550371200
• Email: dagmacancer[@]yahoo.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: January 2018
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Mexico	Hospital General Naval de Alta Especialidad	México, Distrito Federal	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Country where clinical trial is conducted

Mexico, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain level	Pain level measurement at 48 hours determined by the visual analogue scale (Range: 0-10 cm)	48 hours after surgery	Yes
Secondary	Postoperative anxiety level	Postoperative anxiety level determined by STAIC (State Trait Anxiety Inventory Children) (Range: 10-40 points)	48 hours after surgery	Yes
Secondary	Postoperative urinary cortisol level	Postoperative stress level determined by urinary cortisol (µg/dl)	48 hours after surgery	Yes
Secondary	Postoperative heart rate	Postoperative heart rate (beat per minute)	48 hours after surgery	Yes
Secondary	Postoperative respiratory rates	Postoperative breathing frequency (breath per minute)	48 hours after surgery	Yes
Secondary	Postoperative systolic blood pressure	Postoperative systolic blood pressure (mmHg)	48 hours after surgery	Yes
Secondary	Postoperative diastolic blood pressure	Postoperative diastolic blood pressure (mmHg)	48 hours after surgery	Yes
Secondary	Postoperative oxygen saturation	Postoperative oxygen saturation (%)	48 hours after surgery	Yes
Secondary	Length of hospital stay	Postoperative hospital stay length (hours)	168 hours after surgery	Yes