Effectiveness of Manual Therapy Through Osteopathy in the Treatment of Infant Colic.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline FCL Questionnaire at 12 weeks of infants' life.
研究概览
简要总结
This study compares the effectiveness of manual therapy (osteopathy) on infant colic versus education to the family, and a third group with no specific intervention.
详细描述
Infant colic is a problem that affects 10-30% of babies in their first months of life. This research project aims to verify the effectiveness of manual therapy on infant colic. The sample is divided in three groups, performing in the firts one osteopathy manual therapy; in the second one, measures to support and education to the family; and in the third, there is no specific intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Weeks 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed if Infant Colic.
排除标准
- •Babies diagnosed of other pathologies that justify cries, such as reflux, food intolerances or neurological syndromes.
- •Premature babies less than 37 weeks gestation, who may be involved in other concomitant pathologies.
- •Mothers (families) with language barriers, due to the difficulty of collecting data.
研究组 & 干预措施
Osteopathy manual therapy
Osteopathy manual therapy applying the following treatment: Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.
干预措施: Osteopathy manual therapy (Other)
Measures to support and education to the family
Measures to support and education to the family that consist on pedagogical intervention in parents, health education.
干预措施: Measures to support and education to the family (Behavioral)
No specific intervention
No specific intervention, prescriptions by pediatrician
结局指标
主要结局
Change from baseline FCL Questionnaire at 12 weeks of infants' life.
时间窗: At baseline, at 4 weeks, at 8 weeks, at 12 weeks of infants' life and at 3 months of infants' life
FCL (Fisioterapia en el Cólico del Lactante) QUESTIONNAIRE: Infant colic assessment questionnaire. Group CTS (Ciencias y Técnicas de la Salud) 305 of the University of Seville.
次要结局
- Maternal stress in the last month.(At baseline and at 12 weeks of infants' life.)
- Intensity of irritability(At baseline and at 12 weeks of infants' life)
研究者
Adelaida María Castro-Sánchez
PhD
Universidad de Almeria