Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004622
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2023-08-09
Brief Title:
Effectiveness of Calgary Family Intervention Model in Caregivers
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Effectiveness of Calgary Family Intervention Model Improving on Uncertainty Family Functioning and Resilience in Caregivers of Infants and Toddlers Undergoing Open-heart Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Effectiveness of Calgary family intervention model improving on uncertainty family functioning and resilience in caregivers of infants and toddlers undergoing open-heart surgeryResearch hypothesis is The experimental group of caregivers for infants and toddlers undergoing open-heart surgery showed significant differences in uncertainty family functioning and family resilience before surgery prior to transferring out of the intensive care unit and before discharge
Detailed Description:
Background For caregivers of infants and toddlers with congenital heart disease the experience of their young children undergoing open-heart surgery brings about uncertainty including waiting for the childs recovery providing care in the intensive care unit and the possibility of death These uncertainties can significantly impact the caregivers physical and mental well-being as well as their ability to provide subsequent care and nurture for the child Therefore it is crucial to implement intervention measures that focus on caring for the caregivers reducing their sense of uncertainty and implementing effective nursing strategies to enhance family functioning and resilience
Purpose This study aims to investigate the effectiveness of implementing the Calgary Family Intervention Model on caregivers of infants and toddlers undergoing open-heart surgery in terms of reducing their uncertainty improving family functioning and enhancing resilience
Methods This study adopts a quasi-experimental research design and will be conducted at a medical center in northern Taiwan A total of 96 caregivers of infants and toddlers undergoing open-heart surgery will be recruited and a pre- and post-test design will be employed with two groups The control group will receive routine nursing care while the experimental group will receive routine nursing care supplemented with the Calgary Family Intervention Model which encompasses cognitive emotional and behavioral domains The experimental group will participate in two therapeutic sessions 1 The day after surgery and before visiting the child and 2 Prior to transferring out of the intensive care unit Both groups will be assessed using the parental uncertainty perception scale APGAR family function assessment scale and the family resilience scale as outcome measures Data will be collected before surgery prior to transferring out of the intensive care unit and before discharge Interviews will be conducted with the experimental group and data analysis will involve Generalized Estimating Equations GEE for quantitative data and content analysis for qualitative data
Expected contributions In future clinical practice this study aims to provide valuable insights into the use of family nursing intervention for caregivers of infants and toddlers undergoing open-heart surgery specifically in managing the uncertainties associated with the illness context Through therapeutic conversations this intervention can help identify family strengths and resources thereby serving as an important reference strategy for enhancing family resilience
Purpose This study aims to investigate the effectiveness of implementing the Calgary Family Intervention Model on caregivers of infants and toddlers undergoing open-heart surgery in terms of reducing their uncertainty improving family functioning and enhancing resilience
Methods This study adopts a quasi-experimental research design and will be conducted at a medical center in northern Taiwan A total of 96 caregivers of infants and toddlers undergoing open-heart surgery will be recruited and a pre- and post-test design will be employed with two groups The control group will receive routine nursing care while the experimental group will receive routine nursing care supplemented with the Calgary Family Intervention Model which encompasses cognitive emotional and behavioral domains The experimental group will participate in two therapeutic sessions 1 The day after surgery and before visiting the child and 2 Prior to transferring out of the intensive care unit Both groups will be assessed using the parental uncertainty perception scale APGAR family function assessment scale and the family resilience scale as outcome measures Data will be collected before surgery prior to transferring out of the intensive care unit and before discharge Interviews will be conducted with the experimental group and data analysis will involve Generalized Estimating Equations GEE for quantitative data and content analysis for qualitative data
Expected contributions In future clinical practice this study aims to provide valuable insights into the use of family nursing intervention for caregivers of infants and toddlers undergoing open-heart surgery specifically in managing the uncertainties associated with the illness context Through therapeutic conversations this intervention can help identify family strengths and resources thereby serving as an important reference strategy for enhancing family resilience
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None