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

Maharajgunj Medical Campus

Status: Completed

Conditions: Informed Consent; Patient and Caregiver Satisfaction

Treatments: Other: Informed Consent Process Evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT06746207

225-6-12

Details and patient eligibility

About

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.

Enrollment: 384 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

384 participants in 1 patient group

Patients and Caregivers

Description:

This cohort includes two groups: patients undergoing major elective surgery and their caregivers. The patients are asked to provide feedback on their understanding and satisfaction with the informed consent process. The caregivers, who often provide the informed consent on behalf of the patients, are also surveyed to assess their perspectives on the consent process. There is no intervention in this study; the focus is on evaluating perceptions, satisfaction, and the communication process surrounding informed consent in a surgical setting.

Treatment:

Other: Informed Consent Process Evaluation