Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children
|ClinicalTrials.gov Identifier: NCT02563587|
Recruitment Status : Unknown
Verified September 2015 by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Recruitment status was: Recruiting
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Laughter therapy Other: Accompaniment without causing the laughter of children. Drug: Conventional treatment||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy of the Spontaneous Laughter on Postoperative Pain and Anxiety in Children. A Randomized Controlled Trial|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2018|
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 Name: 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 Name: 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 Name: Group CT
- 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)
- Postoperative anxiety level [ Time Frame: 48 hours after surgery ]Postoperative anxiety level determined by STAIC (State Trait Anxiety Inventory Children) (Range: 10-40 points)
- Postoperative urinary cortisol level [ Time Frame: 48 hours after surgery ]Postoperative stress level determined by urinary cortisol (μg/dl)
- Postoperative heart rate [ Time Frame: 48 hours after surgery ]Postoperative heart rate (beat per minute)
- Postoperative respiratory rates [ Time Frame: 48 hours after surgery ]Postoperative breathing frequency (breath per minute)
- Postoperative systolic blood pressure [ Time Frame: 48 hours after surgery ]Postoperative systolic blood pressure (mmHg)
- Postoperative diastolic blood pressure [ Time Frame: 48 hours after surgery ]Postoperative diastolic blood pressure (mmHg)
- Postoperative oxygen saturation [ Time Frame: 48 hours after surgery ]Postoperative oxygen saturation (%)
- Length of hospital stay [ Time Frame: 168 hours after surgery ]Postoperative hospital stay length (hours)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563587
|Contact: Magda Ruth Pérez Cervantes, Pediatrician||(52)5550371200 ext email@example.com|
|Hospital General Naval de Alta Especialidad||Recruiting|
|México, Distrito Federal, Distrito Federal, Mexico, 04480|
|Contact: Magda Ruth Pérez Cervantes, Pediatrician (52)5550371200 ext 5423 firstname.lastname@example.org|
|Principal Investigator:||Magda Ruth Pérez Cervantes, Pediatrician||Secretaria de Marina|