The Effects of Visceral Manual Therapy on Infant Colic Symptoms. A Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from parents-reported infant colic severity at 3 weeks
研究概览
简要总结
The main goal of this study is to get to know if applying manual therapy will reduce the infant colic symptoms for to improve quality of life of babies and parents.
详细描述
Background:
Infant colic is one of the most common disorders in the first year of baby´s life. It is estimated to affect between 10 to 40 % of healthy born children in their first year of life. To determine the effectiveness of a protocol manual therapy in the treatment of colic, using the Infant Colic Severity Questionnaire, we analyzed two intervention groups: experimental in which children received the protocol manual therapy and counseling to parents and the Control group, in which parents received advice only.
Objectives:
To assess the effectiveness of visceral manual therapy to improve the symptoms on infant colic.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 180 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with medical diagnostic of colic following Wessel criteria.
排除标准
- •Infant's parents without full capacity to answer the survey questions, such as the existence of intellectual disability.
- •Babies with neurological disorders such epilepsy, meningitis, encephalitis, cerebral palsy, spina bifida, hydrocephalus, encephalopathy, Arnold Chiari malformation, syringomyelia and Huntington's disease.
- •Babies with digestive disorders, such Crohn's disease, irritable bowel syndrome, peritonitis, intestinal malabsorption, hepatitis, diverticular bowel disease, esophagitis, Intussusception and Ulcerative Colitis.
- •Babies with congenital diseases such Angelmen syndrome, Down syndrome, cystic fibrosis, haemophilia, Klinefelter syndrome, Neurofibromatosis, Patau syndrome and Tay Sachs syndrome.
- •Babies with traumatology - orthopedic pathologies such idiopathic scoliosis, spondylolisthesis, Perthes disease, Meyer dysplasia, Marfan syndrome, Morquio syndrome and congenital hip dislocation.
- •Babies with dermatological diseases such Atopic dermatitis, staphylococcal scalded skin syndrome, psoriasis, urticaria and disorders of skin pigmentation.
- •Babies who are subjected to drug treatments that are not specific to the treatment of colic.
研究组 & 干预措施
GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES
Subjects will receive 2 manual therapy sessions and advices.
干预措施: ADVICES (Other)
GROUP RECEIVING ADVICES
Subjects will receive advices.
干预措施: ADVICES (Other)
GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES
Subjects will receive 2 manual therapy sessions and advices.
干预措施: VISCERAL MANUAL THERAPY-ADVICES (Other)
结局指标
主要结局
Change from parents-reported infant colic severity at 3 weeks
时间窗: At the start of the study and one week after the second session (three weeks after the start of the study)
Evaluated by the infant colic severity scale
次要结局
- Change from parents-reported infant cry at 3 weeks(At the start of the study and one week after the second session (three weeks after the start of the study))
研究者
Raquel Chillón Martínez
PhD
University of Seville