Bariatric Surgery and Patient Education

March 12, 2024 updated by: Gülsüme Satir, Istanbul University - Cerrahpasa (IUC)

The Effect of Education Given to Patients With Two Different Materials Before Bariatric Surgery on Early Complications

Obesity is a disease that poses a health risk and is increasing worldwide. Bariatric surgery is the most effective method used in the treatment of obesity. Preoperative health education for bariatric surgery patients is important to support surgery. There is not enough nursing research in the literature regarding training patients with two different materials before bariatric surgery. The purpose of the randomized controlled experimental study designed in light of this information was to determine the effect of education given to patients with two different materials before bariatric surgery on early complications. The rates of the study were determined by randomizing trial I, trial II, and control treatment in 66 rooms that met the interval and study screening criteria offered between May 2022 and June 2023 in the general surgery service of a university hospital. Data from the research; was collected with the Veria Total Form, Autar Risk Assessment Scale, Apfel Risk Score, Visual Comparison Scale-VAS (Visual Analog Scale-VAS), Training Satisfaction Survey, and Complication Monitoring Form. In the first face-to-face meeting in the experimental groups, we were given training by the researcher with the removable Training Booklet I and Training Booklet II and were monitored until discharge. No control group training was given.

Study Overview

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

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Avcılar
      • İstanbul, Avcılar, Turkey, 34320
        • İstanbul University- Cerrahpasa Instutite Graduate Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2022

Primary Completion (Actual)

May 2, 2022

Study Completion (Actual)

July 18, 2023

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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