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检查基于职业治疗的家长指导对早产儿喂养问题的影响

2026年8月9日 更新者:Rukiye Begüm KOCA、Ankara Medipol University

检查基于职业治疗的家长指导对有早产史的儿童喂养问题的影响

喂养问题在有早产史的儿童中很常见,并且这些问题会持续到幼儿期。 喂养问题受到许多生物心理社会因素的影响,喂养发生的环境以及父母的态度和行为也可能对这些问题的出现或持续产生影响。 我们研究的目的是评估基于职业治疗的家长辅导干预对母亲及其孩子的影响,在我国,母亲和孩子被认为是喂养儿童的主要责任。 我们的研究将包括 46 名早产儿的母亲,参与者将被随机分配到干预组/对照组。 母亲们将通过谷歌表格填写社会人口统计信息表、儿科喂养行为评估量表、感官概况调查问卷 - 口腔感觉处理分测试、家庭喂养策略量表和家长自我效能量表。 研究组的母亲将接受为期10周的基于职业治疗的在线家长辅导培训。 培训结束后进行第二次评估;最终评估将在1个月的随访后进行。

研究概览

研究类型

介入性

注册 (实际的)

39

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ankara/ Altındağ
      • Ankara、Ankara/ Altındağ、土耳其(türkiye)、06110
        • Ankara Medipol University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

描述

纳入标准:

  • 孩子早产(出生周<37)
  • 孩子年龄在3-6岁之间
  • 母亲必须有能力使用在线平台、技术工具和互联网连接。
  • 母亲必须受过足够的教育才能阅读、理解和填写量表。
  • 母亲们抱怨孩子的喂养问题

排除标准:

  • 可能会影响孩子的进食;患有食物过敏、残疾、神经发育疾病、染色体或结构异常
  • 孩子是非口服喂养的
  • 在任何中心接受职业治疗、口腔运动治疗或营养治疗
  • 不允许在干预期间进行视频共享、摄像头/音频共享以及会话录音等做法。

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:研究小组
将接受为期 10 周基于职业治疗的家长辅导干预的母亲将被纳入该组。
基于职业治疗的家长辅导干预将持续 10 次,并将在在线平台上进行。 会议预计持续 45-60 分钟。 课程期间进行的面谈被认为是家长辅导的基本原则;按照共同规划、共同观察、共同实施、共同反思、共同反馈的原则开展。 这项干预措施旨在教育母亲为孩子制定正确的喂养策略,并使他们能够独立执行这些做法。
其他名称:
  • 分发信息手册
其他:对照组
对照组将不会接受主动干预,但会获得一份关于儿童早期发展的信息手册。 此外,研究完成后,将授予参与干预的权利。
不会对目标组中的母亲进行任何主动干预;将分发一份关于儿童早期发展的信息手册。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Behavioral Pediatric Feeding Assessment Scale
大体时间:The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
This scale will be used to evaluate children's nutritional problems. Behavioral Pediatrics Feeding Assessment Scale (BPFAS) was developed by Crist and Napier Philips in 2001 and its original version consists of 35 questions. The usage age range of the survey is between 9 months and 7 years, and it is the scale with the most comprehensive reliability and validity data among the nutrition surveys administered by parents for preschool children. The questionnaire has good test-retest reliability and internal consistency, acceptable-to-good sensitivity, and good-to-excellent specificity. The BPFAS is capable of screening for a broad spectrum of feeding difficulties (nutritional and textural selectivity, food refusal, and oral motor difficulties). Turkish validity study by Önal et al. It was made by in 2017.
The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
Sensory Profile Questionnaire - Oral Sensory Processing Test
大体时间:The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).

This scale will be used to examine how children's oral sensory processing skills change before and after the intervention. Ergotherapist Prof. Sensory Profile of the individual developed by Winnie Dunn; It is a measurement tool used to evaluate sensory modulation, in other words, the tendency to respond to sensory stimuli during daily activities and which sensory systems affect daily life more. It is used in children between the ages of 3-10. The individual; The test, which is used to measure functional performance in daily living activities, sensory processing abilities and sensory processing effects, consists of 3 main sub-parameters (sensory processing, modulation and behavioral-emotional responses) and 9 factor scores consisting of these parameters.

*In our study, it was decided to use only the oral sensory processing subtest of questionnaire.

The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
Canadian Occupational Therapy Measurement (COPM)
大体时间:The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
The Canadian Occupational Performance Measurement (COPM) is an outcome measure designed to identify changes in individuals' perceived performance and satisfaction levels over time in the areas of self-care, productivity, and leisure. In the application of the COPM, the client is first interviewed and listed occupations they want to do, are expected to do, but are unable to do, or are dissatisfied with the way they are performed. Performance and satisfaction levels are recorded before and after the intervention, allowing the difference between the two assessments to be calculated. The COPM will be used in this study to determine participants' goals for the intervention and to examine changes in performance and satisfaction following the intervention for the identified occupations.
The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
Feeding Strategies Quesstionnaire
大体时间:The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
This questionnaire will be used to measure whether mothers' feeding strategies have changed before and after the intervention.It is a scale developed by Berlin et al. in 2005 to measure parents' feeding strategies for their children. FSQ consists of 27 items and is administered to children between the ages of 2-6. FSQ; It consists of 6 subheadings: child control in eating, meal time, environment structure, family control in eating, release and coercive interventions. The FSQ scale includes answers ranging from 1 (strongly disagree) to 5 (strongly agree). It has been reported that the Feeding Strategies Scale can be used to evaluate child and parent feeding strategies regarding the prevention or treatment of pediatric feeding difficulties. A Turkish adaptation study was carried out by Meral in 2017, and the total Cronbach alpha value of the scale is 0.80.
The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
Parental Self-Efficacy Scale
大体时间:The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
This scale will be used to examine how parents' self-efficacy changes before and after parent coaching intervention. Parental Self-Efficacy Scale Guimond et al. It was developed by Cavkaytar et al. in 2005 and adapted into Turkish by Diken in 2007. It is a scale updated in 2014 and used to measure the self-efficacy perceptions of parents of children with disabilities regarding their parenting skills. The scale is a 7-point Likert-type rating scale and consists of a total of 17 items. The lowest score can be obtained from the scale, 17 points, and the highest score can be 119 points. As the score obtained from the scale increases, the level of self-efficacy also increases. Cronbach's Alpha internal consistency coefficient of the scale was found to be 0.95.
The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).

次要结果测量

结果测量
措施说明
大体时间
Numerical Rating Scale
大体时间:This assessment was planned to be applied to the intervention group in post-intervention (T1: week 10) and post-follow-up (T2: week 14) evaluations.
In this study, satisfaction was assessed in parents in the intervention group during post-intervention (T1) and follow-up (T2) evaluations. A single-item 0-10 (0=not satisfied at all, 10=very satisfied) numerical rating scale was used to assess overall satisfaction with Occupational Therapy Based Parent Coaching.
This assessment was planned to be applied to the intervention group in post-intervention (T1: week 10) and post-follow-up (T2: week 14) evaluations.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Gökçen Akyürek, Ph. D.、Hacettepe University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月29日

初级完成 (实际的)

2025年6月22日

研究完成 (实际的)

2025年8月15日

研究注册日期

首次提交

2024年2月6日

首先提交符合 QC 标准的

2024年2月16日

首次发布 (实际的)

2024年2月20日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年8月9日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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