Evaluating Patient and Caregiver Satisfaction with the Informed Consent Process in Surgery

Completed

• Conditions: Informed Consent; Patient and Caregiver Satisfaction

• Registration Number: NCT06746207
• Lead Sponsor: Maharajgunj Medical Campus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-10-15
• Status Verified: 2024-12
• Study Completion: 2024-12-09
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient and Caregiver Satisfaction with the Informed Consent Process	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.

Trial Locations

Locations (1)

Institute of Medicine, Maharajgunj; 🇳🇵 Kathmandu, Bagmati, Nepal