跳至主要内容
临床试验/NCT07576569
NCT07576569尚未招募不适用

Preliminary Effectiveness of a Nursing Intervention Aimed at Improving Adaptation in Patients and Their Caregivers During the Outpatient Postoperative Period Following Myocardial Revascularization

Universidad de la Sabana1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2027年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1

研究概览

简要总结

Introduction: Myocardial revascularization is an essential procedure for patients with cardiovascular disease. Its recovery in the outpatient setting involves significant challenges for both the patient and the caregiver. This recovery phase may generate physical, emotional, and psychological complications that require an effective adaptation process of the patient-caregiver dyad to ensure successful recovery and improved quality of life.

Objective: To evaluate the preliminary effectiveness of a nursing intervention aimed at improving adaptation in the patient-caregiver dyad during the outpatient postoperative period following myocardial revascularization, compared with usual care, in Bucaramanga during the period 2026-2027.

Materials and Methods: A pilot randomized controlled trial will be conducted to develop and evaluate a novel nursing intervention aimed at promoting adaptation in patients undergoing outpatient postoperative myocardial revascularization and their caregivers. The intervention will be designed and its feasibility, acceptability, and preliminary effectiveness will be assessed. Data analysis will be performed using descriptive and inferential statistical methods, considering the distribution and behavior of the data.

Expected Results: The study is expected to assess the preliminary effectiveness of the proposed intervention through the integration of theoretical and empirical components.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants (patients and caregivers) will be blinded to group allocation and will not be informed whether they are receiving the structured nursing intervention or usual care. Outcome assessors will also be blinded to group assignment to reduce assessment bias. Due to the nature of the intervention, care providers and investigators cannot be blinded.

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

  • Adults aged 18 years or older who have undergone myocardial revascularization surgery, completed the immediate postoperative in-hospital period without major complications, and have been discharged for outpatient management according to institutional protocols
  • Patients who, at the time of discharge, do not require ventilatory support, invasive hemodynamic support, or continuous monitoring, and present documented clinical stability
  • Presence of an identified primary caregiver actively involved in the home care process during the outpatient postoperative period
  • Preserved cognitive capacity in both patient and caregiver, allowing understanding of instructions, participation in the intervention, and completion of assessment instruments
  • Written informed consent provided by both patient and caregiver

排除标准

  • Patients presenting severe postoperative complications, such as deep surgical site infection, persistent hemodynamic instability, major neurological events, or readmission to the intensive care unit at the start of the intervention Patients with moderate to severe cognitive impairment, decompensated psychiatric disorders, or neurological conditions that limit understanding, communication, or active participation
  • Caregivers with physical, cognitive, or emotional limitations that compromise the effective performance of the caregiving role during the follow-up period
  • Patients without a clearly identified support network or without an available primary caregiver to participate in the study
  • Concurrent participation in other clinical, educational, or psychosocial intervention studies that may interfere with the proposed intervention
  • Language or cultural barriers that prevent understanding of the intervention content or interaction with the research team, without adequate mediation

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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