Efficacy of the Spontaneous Laughter on Postoperative Pain and Anxiety in Children. A Randomized Controlled Trial
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
- 否
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
Laughter therapy with conventional treatment
干预措施: Laughter therapy (Other)
Group AW-CT
Accompaniment without causing the laughter of children more conventional treatment
干预措施: Accompaniment without causing the laughter of children. (Other)
Group CT
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)
