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临床试验/NCT04221776
NCT04221776已完成不适用

Implementing a New Method of Group Toilet Training in Daycare Centers: a Cluster Randomised Controlled Trial

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2017年11月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Duration of toilet training

研究概览

简要总结

Evaluation of a new method of toilet training (TT), meaning TT in group in daycare centers, guided by a TT expert. Children are included based on signs of readiness for TT.

详细描述

A cluster randomized controlled trial (CRCT) was established in daycare centers. Clusters of participants (per daycare center) were randomly allocated to an Intervention group or a Control group.

Evolution of the TT process was monitored in the daycare center until the child was considered to be fully toilet trained (or 'clean') during the day (this means wearing undergarments, conscious of the need to void and initiating toilet behavior without reminder of the parents with a maximum of one leakage a day [9]).

Daycare workers evaluated the TT process of all participating children on a weekly basis. Parents were asked to fill in an online questionnaire when their child was completely toilet trained.

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
None

入排标准

年龄范围
18 Months 至 30 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •knowledge of the Dutch language
  • •aged between 18 and 30 months
  • •not yet toilet trained during the day and night (diaper dependent)
  • •Parents of the children had to be motivated to participate in the study and willing to invest time and effort in continuing the TT at home
  • •Children met at least two of the following three signs of readiness: the child expresses a need to evacuate and shows awareness of the need to void or to have a bowel movement; the child insists on completing tasks without help and is proud of new skills; or the child can pull clothes up and down in a TT related context

排除标准

  • •Children with urological, neurological, organical or behavior problems

研究组 & 干预措施

Intensive toilet training group

Experimental

Intervention group was subjected to an intensive TT group session lasting 2-hours during 2 consecutive days in daycare centers.

干预措施: Group toilet training in daycare (Other)

Standard care toilet training group

Active Comparator

Children participating in control group did not receive the intensive training, but parents got a leaflet and were encouraged to start TT their child at home, in their own manner.

干预措施: Individual toilet training at home (Other)

结局指标

主要结局

Duration of toilet training

时间窗: 6 weeks

Number of weeks needed for the child to become fully toilet trained

次要结局

  • Effectiveness of toilet training(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tinne Van Aggelpoel

Pelvic floor physiotherapist

University Hospital, Antwerp

研究点 (1)

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