Bariatric Surgery CandidateNCT06309108
Bariatric Surgery and Patient Education
A study testing Education Booklet and Augmented Reality Group in people with Bariatric Surgery Candidate and Education, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bariatric Surgery Candidate, Education, Patient Education
- What is being tested?
- Education Booklet and Augmented Reality Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2022to 18 Jul 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul University- Cerrahpasa Instutite Graduate Studies
Istanbul, Avcılar, 34320
About this study
Official title: 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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate, Education, Patient Education
- Being tested
- Education Booklet, Augmented Reality Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education BookletOther
The education group was given training with a education booklet
Augmented Reality GroupOther
The second of the intervention group was trained with augmented reality. Patients were able to see the augmented reality element with the 3DQR application.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | Education group was given training with a training booklet. Receives: Other: Education Booklet |
| Augmented Reality Group | Experimental | Augmented reality group was given training with a augmented reality with 3DQR application. Receives: Other: Augmented Reality Group |
| Control Group | No intervention | Control group was given training with a hospital routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veria Total Form for sociodemographic features
Measured: [Time Frame: 1 week]
Secondary outcomes (1)
Autar Risk Assessment Scale for DVT
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start2 Jan 2022
- Primary completion2 May 2022
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In our study, patients who would undergo bariatric surgery were selected randomly.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülsüme Satir, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309108
- Sponsor's protocol ID
- 2022/68-04
- Other IDs
- İUC
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Patients With Two Different Materials Before Bariatric Surgery on Early Complications
- ClinicalTrials.gov ID
- NCT06309108
- Acronym / sponsor ID
- 2022/68-04
- Conditions
- Bariatric Surgery Candidate, Education, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 13 Mar 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In our study, patients who would undergo bariatric surgery were selected randomly.
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Other: Education BookletEducation group was given training with a training booklet. |
| Augmented Reality Group | Experimental | Other: Augmented Reality GroupAugmented reality group was given training with a augmented reality with 3DQR application. |
| Control Group | No intervention | –Control group was given training with a hospital routine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Education BookletThe education group was given training with a education booklet | Other | Education Group |
| Augmented Reality GroupThe second of the intervention group was trained with augmented reality. Patients were able to see the augmented reality element with the 3DQR application. | Other | Augmented Reality Group |
Primary outcome
Veria Total Form for sociodemographic features
Time frame: [Time Frame: 1 week]
1 secondary outcome
Autar Risk Assessment Scale for DVT
Time frame: 1 week
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 13 Mar 2024.
- Individual participant dataSharing planned: No
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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?
A study testing Education Booklet and Augmented Reality Group in people with Bariatric Surgery Candidate and Education, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 4 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 13 Mar 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 Turkey (Türkiye). 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?
Veria Total Form for sociodemographic features (time frame: [Time Frame: 1 week]). 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 13 Mar 2024.