- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06309108
Bariatric Surgery and Patient Education
The Effect of Education Given to Patients With Two Different Materials Before Bariatric Surgery on Early Complications
Study Overview
Status
Intervention / Treatment
Detailed Description
Training Booklet Group (Experimental Group I): Patients who were eligible for the research were informed about the purpose, content and method of the research by reading the volunteer information form, and verbal and written permission was obtained from those who agreed to participate in the research voluntarily. Before the surgery, Part I of the Data Collection Form and the Autar Risk Assessment Scale were recorded in the form by the researcher. Before the surgery, the patients were given Educational Booklet I. Patients' questions about the booklet were answered. The Education Satisfaction Survey was filled out by the patients in order to measure their satisfaction with the booklet. When the patient is taken to the service after the surgery, the Data Collection Form II. III. IV. Part V, Apfel Risk Score, VAS, and Complication Monitoring Form were evaluated and recorded until the patient was discharged.
Augmented Reality Group (Experiment II GROUP): Patients who were eligible for the research were informed about the purpose, content, and method of the research by reading the voluntary information form, and verbal and written permission was obtained from those who agreed to participate in the research voluntarily. Before the surgery, Part I of the Data Collection Form and the Autar Risk Assessment Scale were recorded in the form by the researcher. Before the surgery, the patients were given Educational Booklet II. They were asked to install the 3DQR Plus application on their smartphones. The patient's ability to scan the QR code was checked. Patients who could open and read the QR code and who could open 9 QR codes and see the augmented reality element were asked to fill out the Training Satisfaction Survey. When the patient is taken to the service after the surgery, the Data Collection Form II. III. IV. and Part V, Apfel Risk Score, VAS, and Complication Monitoring Form were evaluated and recorded until the patient was discharged.
Control Group Patients Patients who were eligible for the study were informed about the purpose, content, and method of the study by reading the voluntary information form.
Verbal and written permission was obtained from those who voluntarily agreed to participate in the study. Control group patients were not given any training by the researcher, and the service routine was applied. Before the surgery, Part I of the Data Collection Form and the Autar Risk Assessment Scale were recorded in the form by the researcher. When the patient is taken to the service after the surgery, the Data Collection Form II. III. IV. and Part V, Apfel Risk Score, VAS, and Complication Monitoring Form were evaluated and recorded until the patient was discharged.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Avcılar
-
İstanbul, Avcılar, Turkey, 34320
- İstanbul University- Cerrahpasa Instutite Graduate Studies
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to use a smart phone with internet access
- Able to communicate visually and verbally,
- Individuals who can speak, understand and read Turkish are included in the research.
was done.
Exclusion Criteria:
- Unable to use the application,
- Those who want to leave the study for any reason,
- Patients who did not accept the study were not included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education Group
Education group was given training with a training booklet.
|
The education group was given training with a education booklet
|
Experimental: Augmented Reality Group
Augmented reality group was given training with a augmented reality with 3DQR application.
|
The second of the intervention group was trained with augmented reality.
Patients were able to see the augmented reality element with the 3DQR application.
|
No Intervention: Control Group
Control group was given training with a hospital routine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Veria Total Form for sociodemographic features
Time Frame: [Time Frame: 1 week]
|
[Time Frame: 1 week]
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Autar Risk Assessment Scale for DVT
Time Frame: 1 week
|
1 week
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Apfel Risk Score for nausea and vomiting
Time Frame: 1 week
|
1 week
|
Visual Analog Scale-VAS for pain
Time Frame: 1 week
|
1 week
|
Training Satisfaction Survey
Time Frame: 1 week
|
1 week
|
Complication Monitoring Form to determine whether complications develop
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022/68-04
- İUC (Other Identifier: İUC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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