跳至主要内容
临床试验/NCT06004622
NCT06004622已完成不适用

Effectiveness of Calgary Family Intervention Model Improving on Uncertainty, Family Functioning, and Resilience in Caregivers of Infants and Toddlers Undergoing Open-heart Surgery.

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
parental uncertainty perception scale

研究概览

简要总结

Effectiveness of Calgary family intervention model improving on uncertainty, family functioning, and resilience in caregivers of infants and toddlers undergoing open-heart surgery.Research 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.

详细描述

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 child's 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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Father or mother of infants and toddlers aged from 1 month to 3 years (inclusive) undergoing open-heart surgery.
  • Infants and toddlers diagnosed with congenital heart disease who are undergoing their first open-heart surgery.
  • Caregivers who are proficient in the national or Taiwanese language and have normal cognitive abilities.
  • Caregivers who can read and understand Chinese characters, enabling them to complete the questionnaires.
  • After explanation and reading of the informed consent, caregivers will provide written consent for participation.

排除标准

  • Father or mother of newborns who undergoing open-heart surgery within the first month after birth.
  • Caregivers with mental illness or intellectual disabilities.

结局指标

主要结局

parental uncertainty perception scale

时间窗: one year

The Chinese questionnaire consists of 30 items, categorized into four domains: Ambiguity, Lack of Clarity, Lack of Information, and Unpredictability. The scoring method is based on the Likert scale, with scores ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). The possible total score ranges from 30 to 150, with the overall score being the sum of individual item scores. A higher total score indicates a greater sense of uncertainty.

APGAR family function assessment scale

时间窗: one year

The questionnaire encompasses five subscales: Adaptation, Partnership, Growth, Affection, and Resolve. Each subscale consists of one question. A 3-point scoring system is employed, where "Often" is scored as 2 points, "Sometimes" as 1 point, and "Hardly Ever" as 0 points. The total score ranges from 0 to 10. Scores between 7 and 10 indicate a functional family, scores between 4 and 6 suggest a moderately dysfunctional family, and scores from 0 to 3 denote a severely dysfunctional family. In other words, higher scores reflect better family functionality, demonstrating the family's ability to effectively handle problems and make harmonious decisions.

family resilience scale

时间窗: one year

The content of this questionnaire consists of 31 items, categorized into three domains: Belief System, Organizational Patterns, and Family Communication Process. The scoring of the questionnaire utilizes a five-point Likert scale, ranging from a minimum of 1 to a maximum of 5. The scale includes responses of "Strongly Disagree" (1 point), "Disagree" (2 points), "Neutral" (3 points), "Agree" (4 points), and "Strongly Agree" (5 points). The total score range is from 31 to 155 points. Higher scores indicate greater family resilience.

次要结局

  • Interview Outline(approximately one year.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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