- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06266507
조산아의 수유 문제에 대한 작업치료 기반 부모 코칭의 효과 검토
작업치료 기반 부모 코칭이 조산 병력이 있는 아동의 섭식 문제에 미치는 영향 검토
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ankara/ Altındağ
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Ankara, Ankara/ Altındağ, 터키 (Türkiye), 06110
- Ankara Medipol University
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 아이의 미숙아(출생 주 <37)
- 아이는 3~6세 입니다
- 어머니는 온라인 플랫폼, 기술 도구 및 인터넷 연결을 사용할 수 있는 능력이 있어야 합니다.
- 어머니는 저울을 읽고, 이해하고, 채울 수 있는 충분한 교육을 받아야 합니다.
- 자녀의 수유 문제에 대한 불만을 신고하는 어머니
제외 기준:
- 이는 아이의 수유에 영향을 미칠 수 있습니다. 음식 알레르기, 장애, 신경 발달 질환, 염색체 또는 구조적 이상이 있는 경우
- 아이에게 비경구로 먹이를 준다
- 어느 센터에서나 작업치료, 구강운동치료, 영양치료를 받고 있는 경우
- 중재 중 비디오 공유, 카메라/오디오 공유, 세션 녹음 등의 관행을 허용하지 않습니다.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 연구 그룹
10주 동안 작업 치료 기반 부모 코칭 중재를 받을 어머니가 이 그룹에 포함됩니다.
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작업 치료 기반 부모 코칭 개입은 10 세션 동안 지속되며 온라인 플랫폼에서 수행됩니다.
세션은 45~60분 동안 지속될 예정입니다.
세션 중에 진행되는 인터뷰는 학부모 코칭의 기본 원칙으로 간주됩니다. 공동기획, 관찰, 실행, 성찰, 피드백의 원칙에 따라 진행될 예정이다.
이 개입의 목표는 어머니에게 자녀를 위한 적절한 수유 전략을 교육하고 이러한 실천을 독립적으로 수행할 수 있도록 하는 것입니다.
다른 이름들:
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다른: 통제군
대조군은 적극적인 중재를 받지 않지만, 유아 발달에 관한 정보가 담긴 소책자를 제공받을 것입니다.
또한, 연구가 완료되면 중재에 참여할 권리가 부여됩니다.
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대상 그룹의 어머니들에게는 어떤 적극적인 개입도 이루어지지 않을 것입니다; 유아 발달에 관한 정보 제공용 브로셔가 배포될 것입니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Behavioral Pediatric Feeding Assessment Scale
기간: 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).
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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.
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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).
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Sensory Profile Questionnaire - Oral Sensory Processing Test
기간: 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).
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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).
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Canadian Occupational Therapy Measurement (COPM)
기간: 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).
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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.
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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).
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Feeding Strategies Quesstionnaire
기간: 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).
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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.
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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).
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Parental Self-Efficacy Scale
기간: 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).
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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.
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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).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Numerical Rating Scale
기간: 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.
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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.
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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.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Gökçen Akyürek, Ph. D., Hacettepe University
간행물 및 유용한 링크
일반 간행물
- Walton K, Daniel AI, Mahood Q, Vaz S, Law N, Unger SL, O'Connor DL. Eating Behaviors, Caregiver Feeding Interactions, and Dietary Patterns of Children Born Preterm: A Systematic Review and Meta-Analysis. Adv Nutr. 2022 Jun 1;13(3):875-912. doi: 10.1093/advances/nmac017.
- Dev DA, Padasas I, Hillburn C, Stage VC, Dzewaltowski DA. Ecological Approach to Family-Style, Multilevel Child Care Intervention: Formative Evaluation Using RE-AIM Framework. J Nutr Educ Behav. 2022 Aug;54(8):728-744. doi: 10.1016/j.jneb.2022.03.005. Epub 2022 Jun 26.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 169
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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