- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01909583
Pediatric Cardiac Surgery Pre-operative Counselling Study
We have developed a pre-operative educational / counselling booklet with the focus on informing parents / patients about the different stages before, during, and after cardiac surgery that they will encounter; both chronologically and emotionally. With this approach and study our objectives are:
1. To provide anticipatory guidance for parents to decrease parental stress and improve parental experience and preparedness, thus involving the parent as a partner in caring for their child.
We hypothesize that this additional tool will improve parental satisfaction in regards to being prepared for their child's heart surgery.
연구 개요
상세 설명
Our study objectives are to provide anticipatory guidance for parents to decrease parental stress and improve parental experience and preparedness, thus involving the parent as a partner in caring for their child.
A Case-control trial comparing family satisfaction between families that did and did not receive the STAGES-booklet.
Primary endpoints are Family satisfaction score and Family stress score. Secondary endpoints are Percentage of families that would recommend the STAGES-booklet as routine pre-operative educational tool, as well as Family Stress score during each stage as outlined in the STAGES-booklet
The Study period either 1 year or once 100 participants enrolled have completed their post-operative survey
Methods Group allocation: The first 50 families will be assigned to the STAGES-post group, and the last 50 to the STAGES-pre group. In both groups participants will be blinded to their timing of exposure to the intervention. This randomization in an attempt to minimize educator bias of possibly giving the STAGES-post group information pertaining to the intervention proposed.
Time points: Routinely after the cardiologist informs families that their child has a cardiac condition needing intervention, the Variety Children's Heart Centre clinical resource nurses, meet with families to help them navigate through upcoming events, do pre-operative counselling and supply them with educational material. At this point parents will be asked in a sensitive manner, whether they would consent to taking part in this study (see consent form). The first 50 will be informed that they will receive a booklet (not disclosing the STAGES-booklet) post-operatively to evaluate and a survey to complete post-operatively. The subsequent 50 families will be given the STAGES-booklet (not disclosing that STAGES is the interventional tool being investigated) together with the other routine educational material, and be counselled according to the STAGES-philosophy. Before leaving the province for cardiac surgery, the RN's will in addition to logistical matters, repeat the STAGES-booklet review and teaching with the STAGES-pre group.During the routine post-operative visit at 6-12 weeks, families will be warned that their visit will be approximately 20-30 minutes longer to complete the post-operative evaluation-survey. The STAGES-post group will be given the STAGES-booklet and informed of the STAGES-philosophy before completing the post-operative survey.In both groups, parents will receive condition specific teaching that is part of routine care currently.
Data collection : Surveys will contain only the family's study number in order to remain anonymous. Data will be analyzed collectively at the end of the study.
Survey responses will be aggregated and appropriate statistical analysis performed by the CHARM statistician.
Expected outcomes:Mean Family satisfaction scores will be 10-20% higher, and mean emotional stress scores 10-20% lower in the STAGES-pre group compared to the STAGES-post group. More than 80% of families in each group will recommend the STAGES-booklet and/or philosophy to be used as a routine pre-operative tool.
Results will be published in a respectable influential journal, submitted to national and international conferences, with the goal to promote the use of STAGES, across Canada and internationally.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Manitoba
-
Winnipeg, Manitoba, 캐나다
- Variety Children's Heart Centre
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
1. All consented families of children <18 years that will be sent out of province for cardiac surgery from the Variety Children's Heart Centre
Exclusion Criteria:
1. Families that can't read or write english
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: STAGES PRE-GROUP
INTERVENTION: this group will receive our "STAGES" booklet PRE-operatively
|
STAGES-booklet was designed by the investigators focussing on guiding parents through the pre-operative and operative admission period.
|
위약 비교기: STAGES POST-GROUP
INTERVENTION: This arm will only receive the STAGES-booklet POST-operatively
|
STAGES-booklet was designed by the investigators focussing on guiding parents through the pre-operative and operative admission period.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Family satisfaction and stress score
기간: up to 6 weeks post-operatively
|
At post-operative visit families will complete a study questionnaire evaluating their satisfaction of pre-operative preparation and their stress levels during the surgical period
|
up to 6 weeks post-operatively
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Percentage of families that would recommend the STAGES-booklet as routine pre-operative educational tool.
기간: 1 day (At post-operative visit)
|
1 day (At post-operative visit)
|
Family Stress score during each stage as outlined in the STAGES-booklet
기간: 1 day (At post-operative visit)
|
1 day (At post-operative visit)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: David Horne, MD, University of Manitoba
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
선천성 심장 질환에 대한 임상 시험
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University of... 그리고 다른 협력자들아직 모집하지 않음심부전, 수축기 | 박출률이 감소된 심부전 | 심부전 New York Heart Association Class IV | 심부전 New York Heart Association Class III폴란드
-
Novartis Pharmaceuticals완전한핵심 연구의 12개월 치료 기간을 성공적으로 완료한 환자(de Novo Heart Recipients)는 EC-MPS 치료에 관심이 있었습니다.
-
University of WashingtonAmerican Heart Association완전한심부전,울혈 | 미토콘드리아 변경 | 심부전 New York Heart Association Class IV미국
STAGES-Booklet에 대한 임상 시험
-
Federal University of the Valleys of Jequitinhonha...완전한