Informed ConsentNCT06746207
Evaluating Patient and Caregiver Satisfaction with the Informed Consent Process in Surgery
An observational study of Informed Consent and Patient and Caregiver Satisfaction, run by Maharajgunj Medical Campus at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Informed Consent, Patient and Caregiver Satisfaction
- What is being tested?
- Informed Consent Process Evaluation
- How many people
- 384 participants
- Where
- 1 siteNepal
- Study dates
- 1 Oct 2023to 9 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients undergoing major elective surgeries across various departments, including General Surgery, Neurosurgery, Plastic Surgery, Urology, ENT, Orthopedics, and Obstetrics \& Gynecology. Caregivers of these patients, typically responsible for providing informed consent, will also be included. The study aims to capture the perspectives of both groups regarding the informed consent process.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Patient and Caregiver Satisfaction on the Informed Consent Process in Surgical Practice in a Tertiary Care Centre: a Cross-Sectional Study
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.
Read more
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.
- Being tested
- Informed Consent Process Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informed Consent Process EvaluationOther
This study does not involve a clinical intervention. Instead, it focuses on evaluating the existing process of informed consent in a surgical setting. Patients and caregivers will be surveyed to assess their understanding, satisfaction, and perceptions of the informed consent process. The study examines factors such as clarity of information provided, patient and caregiver involvement, and overall satisfaction with the process, without altering the current practices. The goal is to identify areas for improvement in communication and documentation, ensuring that patient rights and autonomy are respected.
| Study group | Role | What they receive |
|---|---|---|
| Patients and Caregivers | 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. Receives: Other: Informed Consent Process Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Caregiver Satisfaction with the Informed Consent Process
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.
Measured: Within 24 hours of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Oct 2023
- Primary completion15 Oct 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharajgunj Medical Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asim Shrestha, Maharajgunj Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746207
- Sponsor's protocol ID
- 225-6-12
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this is an observational study focused on evaluating the informed consent process, Individual Participant Data (IPD) will not be shared as part of the study's results. However, the aggregated findings, such as overall satisfaction scores and analysis of demographic factors influencing consent understanding, will be presented in the final study report.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Patient and Caregiver Satisfaction on the Informed Consent Process in Surgical Practice in a Tertiary Care Centre: a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06746207
- Acronym / sponsor ID
- 225-6-12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Maharajgunj Medical CampusUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients and Caregivers | – | Other: Informed Consent Process EvaluationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients undergoing major elective surgeries across various departments, including General Surgery, Neurosurgery, Plastic Surgery, Urology, ENT, Orthopedics, and Obstetrics \& Gynecology. Caregivers of these patients, typically responsible for providing informed consent, will also be included. The study aims to capture the perspectives of both groups regarding the informed consent process.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informed Consent Process EvaluationThis study does not involve a clinical intervention. Instead, it focuses on evaluating the existing process of informed consent in a surgical setting. Patients and caregivers will be surveyed to assess their understanding, satisfaction, and perceptions of the informed consent process. The study examines factors such as clarity of information provided, patient and caregiver involvement, and overall satisfaction with the process, without altering the current practices. The goal is to identify areas for improvement in communication and documentation, ensuring that patient rights and autonomy are respected. | Other | Patients and Caregivers |
Primary outcome
Patient and Caregiver Satisfaction with the Informed Consent Process
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No. Since this is an observational study focused on evaluating the informed consent process, Individual Participant Data (IPD) will not be shared as part of the study's results. However, the aggregated findings, such as overall satisfaction scores and analysis of demographic factors influencing consent understanding, will be presented in the final study report.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Informed Consent and Patient and Caregiver Satisfaction, run by Maharajgunj Medical Campus at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Caregiver Satisfaction with the Informed Consent Process (time frame: Within 24 hours of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.