NCT06309108

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

December 15, 2023

Last Update Submit

March 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Veria Total Form for sociodemographic features

    [Time Frame: 1 week]

Secondary Outcomes (1)

  • Autar Risk Assessment Scale for DVT

    1 week

Other Outcomes (4)

  • Apfel Risk Score for nausea and vomiting

    1 week

  • Visual Analog Scale-VAS for pain

    1 week

  • Training Satisfaction Survey

    1 week

  • +1 more other outcomes

Study Arms (3)

Education Group

EXPERIMENTAL

Education group was given training with a training booklet.

Other: Education Booklet

Augmented Reality Group

EXPERIMENTAL

Augmented reality group was given training with a augmented reality with 3DQR application.

Other: Augmented Reality Group

Control Group

NO INTERVENTION

Control group was given training with a hospital routine.

Interventions

The education group was given training with a education booklet

Education 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.

Augmented Reality Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University- Cerrahpasa Instutite Graduate Studies

Istanbul, Avcılar, 34320, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: In our study, patients who would undergo bariatric surgery were selected randomly.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Istanbul University- Cerrahpaşa PhD student

Study Record Dates

First Submitted

December 15, 2023

First Posted

March 13, 2024

Study Start

January 2, 2022

Primary Completion

May 2, 2022

Study Completion

July 18, 2023

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations