Evaluating Patient and Caregiver Satisfaction on the Informed Consent Process in Surgical Practice in a Tertiary Care Centre: a Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Patient and Caregiver Satisfaction with the Informed Consent Process
研究概览
简要总结
The goal of this observational study is to evaluate patient and caregiver satisfaction with the informed consent process in surgical practice at a tertiary care center in Nepal. The main questions it aims to answer are:
How satisfied are patients and caregivers with the current informed consent process in surgery? How well do patients and caregivers understand the informed consent information provided? Are there differences in satisfaction and understanding based on factors such as education level or family involvement? Researchers will compare the perceptions of patients and caregivers to understand if there are gaps in communication and satisfaction.
Participants will:
Complete a structured questionnaire assessing their understanding and satisfaction with the informed consent process.
Share their views on the type and quality of information provided during the consent process.
Rate their satisfaction on a 10-point scale based on their experience with the informed consent procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older undergoing major elective surgical procedures requiring regional or general anesthesia.
- •Caregivers of eligible patients who provide informed consent on behalf of the patient.
- •Willingness to participate and provide consent for the study.
排除标准
- •Patients undergoing emergency surgeries.
- •Patients who are unable to participate due to language barriers or cognitive impairment.
- •Patients or caregivers who refuse to participate in the study.
结局指标
主要结局
Patient and Caregiver Satisfaction with the Informed Consent Process
时间窗: Within 24 hours of the surgery
Satisfaction with the informed consent process will be evaluated using a structured questionnaire. Patients and caregivers will rate satisfaction on a 10-point Likert scale (1 = least satisfied, 10 = most satisfied) and respond to Yes/No questions assessing their understanding of the surgery's nature, risks, long-term effects, and anesthesia-related complications. Additional questions evaluate the clarity and completeness of the consent form, including whether essential components (e.g., patient name, diagnosis, procedure details, and risks) were documented. Responses aim to identify gaps in the consent process and assess whether it meets patient and caregiver expectations, as well as legal and ethical standards.
次要结局
未报告次要终点
研究者
Asim Shrestha
Principal Investigator
Maharajgunj Medical Campus