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临床试验/NCT02563587
NCT02563587Unknown不适用

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

Hospital General Naval de Alta Especialidad - Escuela Medico Naval1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
210
试验地点
1
主要终点
Postoperative pain level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Endocrinopathies carriers, cancer, abnormalities of central nervous system immune disorders patients.
  • Patients treated with both topical and systemic steroids

研究组 & 干预措施

Group LT-CT

Experimental

Laughter therapy with conventional treatment

干预措施: Laughter therapy (Other)

Group AW-CT

Placebo Comparator

Accompaniment without causing the laughter of children more conventional treatment

干预措施: Accompaniment without causing the laughter of children. (Other)

Group CT

Sham Comparator

Conventional treatment only

干预措施: Conventional treatment (Drug)

结局指标

主要结局

Postoperative pain level

时间窗: 48 hours after surgery

Pain level measurement at 48 hours determined by the visual analogue scale (Range: 0-10 cm)

次要结局

  • Postoperative heart rate(48 hours after surgery)
  • Length of hospital stay(168 hours after surgery)
  • Postoperative urinary cortisol level(48 hours after surgery)
  • Postoperative diastolic blood pressure(48 hours after surgery)
  • Postoperative oxygen saturation(48 hours after surgery)
  • Postoperative anxiety level(48 hours after surgery)
  • Postoperative systolic blood pressure(48 hours after surgery)
  • Postoperative respiratory rates(48 hours after surgery)

研究者

发起方
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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