- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04121390
Assessing the Impact of Mount Sinai Parenting Center's Newborn Class
Accessing the Effectiveness of a Pediatrician-led Newborn Parenting Class on Maternal Newborn Care Knowledge, Anxiety and Confidence
연구 개요
상세 설명
The important role positive parenting plays in promoting a child's developmental trajectory has led to the design and implementation of many postpartum education initiatives. With 99% of babies in the U.S. born in hospitals, there is a uniqueness of being in the hospital for an extended period of time with the opportunity to educate parents on the importance of promoting early development. Pediatricians are uniquely well-positioned to address both medical and developmental concerns parents may have during critical periods in a child's development, yet very few interventions are led by pediatricians. The Mount Sinai Parenting Center designed the Newborn Parent Education and Discharge Class (hereafter referred to as Newborn Class) to address this issue. The class is 1-hour long and taught be pediatric attending and residents to all families who deliver well babies at Mount Sinai. The class aims to educate parents about medical issues, responsive parenting, and sleep. It is currently taught every Tuesdays and Thursdays. Because of the limited availability of the class, not all mothers have the opportunity to attend. This research study will survey first time mothers of newborns to explore the effectiveness of attending the class. The study team hypothesizes that attending the class would result in increased knowledge on newborn care, increased confidence levels and decreased levels of anxiety.
First time mothers who delivered a full-term singleton vaginally with no major complications were included in the study. Only mothers who attended the class (intervention) or expressed desire to attend class but were discharged before a class was offered (control) were included in analysis. Mothers were recruited between May 2018 and August 2019 at the Klingenstein Pavilion of Mount Sinai. Maternal self-perceived anxiety and confidence were measured using standardized scales, and knowledge on newborn care was assessed using an internally-developed scale.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10029
- Mount Sinai Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- First-time mother
- Above 18 years old
- Vaginal delivery of a healthy full-term singleton
- No major perinatal complications (per self-report)
- Consent to participate.
Exclusion Criteria:
-none
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Newborn Parenting Class
New Mother who attended the Newborn Parenting Class
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Newborn Parenting Class designed by Mount Sinai Parenting Center.
The class is 1-hour long and taught be pediatric attending and residents to all families who deliver well babies at Mount Sinai.
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New Mothers
New Mothers who expressed interest, but did not attend the Newborn Parenting Class
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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State-Trait Anxiety Inventory for Adults (STAI)
기간: Immediately after enrollment (Day 1)
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Maternal self-perceived anxiety was measured using State-Trait Anxiety Inventory for Adults (State only).
A 40 self-report items questionnaire, each item scored on 4-point likert-type response scale from 1 (not at all) to 4 (almost always), full range from 20 to 80, with higher score STAI scores suggesting higher levels of anxiety
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Immediately after enrollment (Day 1)
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Karitane Parenting Confidence Scale (KPCS)
기간: Immediately after enrollment (Day 1)
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Confidence level was measured using Karitane Parenting Confidence Scale.
A 15 item instrument with ach item on the KPCS is scored 0, 1, 2, or 3. Total score range from 0-45, with higher score indicating the parent feeling more confident.
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Immediately after enrollment (Day 1)
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Newborn Care Knowledge Questionnaire
기간: Immediately after enrollment (Day 1)
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Knowledge on newborn care was assessed using an internally-developed scale, developed by a team of pediatricians and specialists. Total score ranges from 0-10, with higher score indicating higher level of knowledge. |
Immediately after enrollment (Day 1)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dani Dumitriu, MD, PhD, Columbia University Irving Medical Center; Icahn School of Medicine at Mount Sinai
- 수석 연구원: Blair S Hammond, MD, Icahn School of Medicine at Mount Sinai
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
기타 연구 ID 번호
- GCO 18-0778
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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