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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06309108
Other study ID # 2022/68-04
Secondary ID IUC
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2022
Est. completion date July 18, 2023

Study information

Verified date March 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 18, 2023
Est. primary completion date May 2, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Education Booklet
The education group was given training with a education booklet
Augmented Reality Group
The second of the intervention group was trained with augmented reality. Patients were able to see the augmented reality element with the 3DQR application.

Locations

Country Name City State
Turkey Istanbul University- Cerrahpasa Instutite Graduate Studies Istanbul Avcilar

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Apfel Risk Score for nausea and vomiting 1 week
Other Visual Analog Scale-VAS for pain 1 week
Other Training Satisfaction Survey 1 week
Other Complication Monitoring Form to determine whether complications develop 1 week
Primary Veria Total Form for sociodemographic features [Time Frame: 1 week]
Secondary Autar Risk Assessment Scale for DVT 1 week
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