AzTrials
AzTrials

Congenital Heart DiseaseNCT05852106

The Effect of 3D Heart Modelling on Family Quality of Life and Surgical Success

A study testing Surgical Simulation with 3D Heart Model and Parental Education with "Congenital Heart Disease Parent Education Booklet" and tailored 3D Heart Modeling in people with Congenital Heart Disease, run by Yeditepe University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Introduction and Objective: In recent years, 3D (three-dimensional) modeling has been added to traditional and effective diagnostic methods such as Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Echocardiography. Read more about this study

Who is it for?
Ages 0 to 18 years
Conditions the study is for
Congenital Heart Disease
What is being tested?
Surgical Simulation with 3D Heart Model and Parental Education with "Congenital Heart Disease Parent Education Booklet" and tailored 3D Heart Modeling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2023to 1 Feb 2024
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 0 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • The participant has a congenital heart disease between the ages of 0-18 years, the congenital defect has extracardiac structure malformations (This is because the modeling is to be done before the operation is done in a shorter time, and it is desired to be trained for preoperative education). Hollow modeling requires more detailed technique and time (Bhatla et al., 2017). In addition, the difficulty of 3D printing the hollow model made in the pilot study was also effective in this decision),
  • Being a candidate for elective surgery,
  • Having a contrast-enhanced CT image taken during and before the patient's routine diagnostic procedure outside the scope of the study,
  • Having at least 15 days between the imaging and the surgical procedure plan,
  • The parents/legal guardians who gave permission to participate in the study were the inclusion criteria of the study.

Who cannot join

  • Patients who do not require CT for diagnosis or treatment (no patient will undergo CT imaging within the scope of the study unless necessary for this study only),
  • Emergency surgical procedures, heart defects involving intracardiac structures (Atrial Septal Defect, Ventricular Septal Defect, Tetralogy of Fallot),
  • Additional anomalies/syndromes,
  • Chronic diseases (such as neurodevelopmental disorders, bleeding disorders, asthma, or Down syndrome),
  • History of cardiac arrest, contrast agent reflection in the images,
  • Image quality preventing modeling.

Trial locations and contacts

1 site in 1 country.

AYLIN AKCA SUMENGEN, PhD contact

5458411453

aylnakca@gmail.com

ABDULVELI ISMAILOGLU, PhD contact

5385044407

abdulveli.ismailoglu@gmail.com

Turkey (Türkiye)1 site

  • Yeditepe University

    Istanbul, 34755

    AYLIN AKCA SUMENGEN, PhD, 05458411453, aylin.akca@yeditepe.edu.tr

    ABDULVELI ISMAILOGLU, PhD

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of 3D Modeling on Family Quality of Life, Surgical Success and Patient Outcomes in Congenital Heart Diseases: A Randomized Controlled Trial Protocol

Introduction and Objective: In recent years, 3D (three-dimensional) modeling has been added to traditional and effective diagnostic methods such as Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Echocardiography. The purpose of this study is to determine the effectiveness of models created from patients' own radiological images using 3D printing technology in the clinical setting to simulate surgery in the preoperative period and provide preoperative parental education to improve family quality of life and positively influence patient outcomes.

Methods: The study is a two-group pretest-posttest randomized controlled study. The children who come to the outpatient clinic examination in a private hospital and who are subjected to Computed Tomography (CT) examination for diagnostic procedures will be modeled in the experimental group, pre-tests will be applied, and the model will be 3D printed after it is approved by the radiologist who is among the researchers. The sample size is 15 experimental group and 15 control group. After the radiologist's approval, surgical simulation and preoperative education will be applied to the experimental group. The control group will receive the same parent education as the standard model. Both groups will complete the Sociodemographic Information Form, Surgical Simulation Evaluation Form - Part I, and Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module one week prior to hospitalization. Surgical simulation and preoperative education will be completed on the same day. On postoperative day 0, only the Surgical Simulation Evaluation Form - Part II will be applied and on postoperative day 15, the Surgical Simulation Evaluation Form - Part II and the Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module will be applied to both groups as a posttest.

Pilot Study and Results: Modeling and 3D printing studies were conducted to carry out the study. A total of four diagnosed and treated patients were retrospectively analyzed. An intracardiac anomaly was detected in the patient data taken for the first model. It was decided to model the extracardiac structures since the inside of the heart was filled with blood, and the blood could not be ruled out as a solid structure. Finally, aortic coarctation was modeled clearly from the images taken and completed.

Read the detailed description

The most common congenital malformation of childhood is congenital heart disease (CHD). The degree to which the defect deviates from normal anatomy determines the severity of symptoms. Globally, between 0.8% and 1.2% of all live births are affected by CHD. While it occurs in 1% of 40,000 live births in the US, Asian countries have been reported to have the highest rate at 9.3 per 1000 live births. In Turkey, the rate has been reported to be between 0.6 and 1% per 100 live births. Between 25 % and 50 % of the children born with CHD have defects that will require open heart surgery. Reliable diagnostic methods provide much better treatment options, leading to a significant reduction in mortality. In addition to imaging methods such as Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Echocardiography (ECHO), 3D modeling and printing technologies have been added to these methods in recent years. There are differences and benefits among the different imaging methods. The most recent and rapidly developing method among them is 3D printing technologies.

It is predicted that 3D cardiac models obtained from patients' radiological images can be used for various purposes. It is stated that beneficial results can be obtained for multiple purposes, from planning and simulation before the definitive surgical procedure to patient-specific preoperative education. There are several techniques for modeling organs using 3D printing technology, which has developed rapidly in recent years. For the heart, two types of cardiac modeling are performed. These are filled solid models (blood pool) and hollow models. The hollow models are obtained from signals sent in a way that limits the perimeter of the area where the blood pool is located. These models are printed as a cross-section and show the intracardiac structure. However, technically, the peak heart rate of children is higher than that of adults, so the images may lose clarity, require more time and effort, and may not be as useful. Solid models have filled models of the atria and ventricles. They are typically modeled and printed from contrast-enhanced CT or MR images. Noncardiac structures can be added to these models (e.g., aorta, pulmonary artery, extracardiac vessels, trachea, and esophagus) with the goal of delineating large vessel abnormalities in the model. Extracardiac structures are very guiding in surgical simulation with easier and faster modeling than intracardiac structures. In particular, recurrent pulmonary artery stenosis and aortic coarctation can be successfully treated, and positive outcomes can be achieved with fast and patient-specific models. The operating time of surgically simulated patients is reduced, and procedures can be completed with less cost and fewer complications.

Targeted patient outcomes can be achieved by managing a multidisciplinary team that includes the patient and family and by using surgical simulation. In life-threatening diseases such as CHD, diagnosis, treatment, and surgical planning are long-term processes. This process causes serious psychological distress in parents, such as post-traumatic stress disorder. Parental/caregiver stress increases and the family's quality of life deteriorates, especially when the surgical procedure and interventions are not clearly understood. This situation negatively affects the postoperative recovery process of patients. A surgical procedure performed with good technique followed by poor postoperative management renders many interventions ineffective. Understanding the severity of the disease from the perspective of the parents can improve both the health-related quality of life of the child and the quality of life of the family, leading to more positive patient outcomes. Patient-specific modeling using 3D printing technology with images obtained through traditional methods is believed to eliminate all of these issues.

Being tested
Surgical Simulation with 3D Heart Model and Parental Education with "Congenital Heart Disease Parent Education Booklet" and tailored 3D Heart Modeling
Keywords
congenital heart diseases, 3D printing; heart modeling, family quality of life, surgical simulation
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical Simulation with 3D Heart Model and Parental Education with "Congenital Heart Disease Parent Education Booklet" and tailored 3D Heart ModelingOther

    Also called Surgical Simulation with CT and MRI and Parental Education with "Congenital Heart Disease Parent Education Booklet"

    The first step in the modeling process is masking. For this study, the average minimum value for masking ventricles and large vessels was set between 80 and 200 HU (Brüning et al., 2022). Threshold values of min 216 HU - max 1502 HU are used. At these HU values, the blood in the heart and great vessels is masked and the outline of the heart is revealed. Lowering the minimum HU value is necessary to make the heart walls more visible. However, this results in masking unwanted soft tissues other than the heart, such as muscle and fat. The masked unnecessary surrounding tissues are removed first with the cropping mask and then manually by marking along the contours of the heart and great vessels. Thus, a model containing only the heart and the desired large vessels will be created and cleaned from the surrounding tissues. With this mask, 3D reconstruction will be performed, and the model will be ready for printing.

Study groups in NCT05852106
Study groupRoleWhat they receive
ExperimentalExperimentalPreoperative:Once the surgery date is set, appointments will be made with the surgeon for surgical simulation and with the family for education one week prior to surgery. The surgeon will be asked to complete the Surgical Simulation Evaluation Form-Part I. At the same time, another researcher will complete the family sociodemographic information form and PedsQL questions in the examination room. After completion of the pre-test and the surgical simulation, the families are given a 30-minute preoperative education with the "Congenital Heart Disease Parent Education Booklet", together with a life-size 3D heart model obtained from their child's own heart, and drawings on paper where they are not understood. Postoperative: After surgery, the patient will be followed until discharge, and only Part II of the Surgical Simulation Evaluation Form will be completed. On the 15th postoperative day, the Surgical Simulation Evaluation Form Part II and the PedsQL will be given again as a posttest.
Receives: Other: Surgical Simulation with 3D Heart Model and Parental Education with "Congenital Heart Disease Parent Education Booklet" and tailored 3D Heart Modeling
Control GroupNo interventionPreoperative:When the operation date is determined, one week before the operation, the patients included in the study's control group will be asked the Sociodemographic Information Form and Pediatric Quality of Life Inventory Family Module (PedQL) questions in the examination room. After the pretest, standardized education will be given to the families. The disease process will be explained to the patients with the same 'Congenital Heart Diseases Parent Education Booklet', and the disease process will be presented with the heart model used in standard medical faculty anatomy courses and the ununderstood parts will be detailed by drawing on paper. The remaining 15 minutes of the education will be conducted as a question and answer with the parents. Postoperative:After the operation, the Surgical Simulation Evaluation Form Part II and PedsQL will be filled out again as post-tests for this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pretest-Family Impacts Module of the Pediatric Quality of Life Inventory PedsQL

    The Turkish validity and reliability study of this scale, first developed by Varni et al. in 2004, was conducted and published by Gürkan et al. in 2019 (Gürkan, Bahar, Çapık, Aydoğdu, \& Beşer, 2020; Varni, Sherman, Burwinkle, Dickinson, \& Dixon, 2004). The data on the sub-dimensions and Cronbach alpha values of this scale, which has 8 sub-dimensions in total, are as follows; physical (0.85), emotional (0.83), social (0.82), cognitive (0.86), communication (0.51), anxiety (0.79) activities of daily living (0.89), family relationships (0.95). A total score of 0.92 was reported. In addition, Cronbach alpha values for all subscales were also included in the original study. The scale does not have a cut-off point. A high score indicates a good family quality of life functioning, while a low score indicates a negative family quality of life. Within the scope of this study, a comparison between mean scores will be made.

    Measured: 1 week prior to surgery

  2. Posttest-Family Impacts Module of the Pediatric Quality of Life Inventory PedsQL

    The Turkish validity and reliability study of this scale, first developed by Varni et al. in 2004, was conducted and published by Gürkan et al. in 2019 (Gürkan, Bahar, Çapık, Aydoğdu, \& Beşer, 2020; Varni, Sherman, Burwinkle, Dickinson, \& Dixon, 2004). The data on the sub-dimensions and Cronbach alpha values of this scale, which has 8 sub-dimensions in total, are as follows; physical (0.85), emotional (0.83), social (0.82), cognitive (0.86), communication (0.51), anxiety (0.79) activities of daily living (0.89), family relationships (0.95). A total score of 0.92 was reported. In addition, Cronbach alpha values for all subscales were also included in the original study. The scale does not have a cut-off point. A high score indicates a good family quality of life functioning, while a low score indicates a negative family quality of life. Within the scope of this study, a comparison between mean scores will be made.

    Measured: 15 days later to surgery

  3. Posttest-Surgical Simulation Questionnaire Part II

    It has 7 questions prepared according the literature. Effects of 3D modeling on surgical complications, duration of the operation, duration of the hospitalization, duration of the intensive care unit, need of recurrent surgery, Unusual complications (except for pain, cardiopulmonary resuscitation, need for ECMO (Extracorporeal Membrane Oxygenation), Seizure, rhythm changes, etc.)

    Measured: First post operative day

  4. Posttest-Surgical Simulation Questionnaire Part II

    It has 7 questions prepared according the literature. Effects of 3D modeling on surgical complications, duration of the operation, duration of the hospitalization, duration of the intensive care unit, need of recurrent surgery, Unusual complications (except for pain, cardiopulmonary resuscitation, need for ECMO (Extracorporeal Membrane Oxygenation), Seizure, rhythm changes, etc.)

    Measured: 15 days later to surgery

Secondary outcomes (1)

  1. Pretest Surgical Simulation Questionnaire Part I

    Surgeon's professional experience and age, opinions about 3D Heart Modeling (surgical simulation evaluations such as effectiveness on techniques of the operations, opinions about strong and week sides of 3D modeling)

    Measured: 1 week prior to surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start1 Jul 2023 (estimated)
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Feb 2024 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be conducted in two hospitals affiliated with a foundation in Istanbul, located in the Marmara Region of Turkey. The imaging used in this study, including patients examined and diagnosed by the pediatric cardiology specialist doctor from the researchers involved, will be checked with a specialist radiology doctor in another hospital belonging to the same foundation. Patients included in the study will be determined with images that can be modeled and meet the inclusion and exclusion criteria. The target sample will include parents of children scheduled to undergo cardiac surgery. The study will be explained to the legal guardian/parent of the identified volunteer patients, and those who wish to participate and give written consent will be included.
Masking
Single blind
Who is masked
Care provider
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05852106
Sponsor's protocol ID
Yeditepe University Nursing
Status last verified
May 2023
First submitted
20 Apr 2023
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Researchers will ensure that all data are accurately and completely coded and consistently entered into the statistical analysis software. The researchers will keep all original documents including medical records, questionnaires, informed consent forms, and other relevant records obtained during the study and will keep them confidential. Data will be retained for five years after the completion of the study.

Publications

  • Abdullah KA, Reed W. 3D printing in medical imaging and healthcare services. J Med Radiat Sci. 2018 Sep;65(3):237-239. doi: 10.1002/jmrs.292. Epub 2018 Jul 3.

    PubMed 29971971

  • AHA. (2023). How 3D Printing Is Impacting Clinical Care. Anatomical Models. Retrieved from https://www.aha.org/aha-center-health-innovation-market-scan/2022-06-07-3-ways-3d-printing-revolutionizing-health-care

  • Anwar S, Singh GK, Miller J, Sharma M, Manning P, Billadello JJ, Eghtesady P, Woodard PK. 3D Printing is a Transformative Technology in Congenital Heart Disease. JACC Basic Transl Sci. 2018 May 30;3(2):294-312. doi: 10.1016/j.jacbts.2017.10.003. eCollection 2018 Apr.

    PubMed 30062215

  • Atalay, B., Güler, R., & Haylı, Ç. M. (2021). Investigation of Preoperative Anxiety Levels in Pediatric Groups. Turkish Journal of Health Science and Life, 4(1), 24-26.

  • Awori J, Friedman SD, Chan T, Howard C, Seslar S, Soriano BD, Buddhe S. 3D models improve understanding of congenital heart disease. 3D Print Med. 2021 Sep 2;7(1):26. doi: 10.1186/s41205-021-00115-7.

    PubMed 34471999

  • Azhar AS, AlShammasi ZH, Higgi RE. The impact of congenital heart diseases on the quality of life of patients and their families in Saudi Arabia. Biological, psychological, and social dimensions. Saudi Med J. 2016 Apr;37(4):392-402. doi: 10.15537/smj.2016.4.13626.

    PubMed 27052282

  • Ballard DH, Mills P, Duszak R Jr, Weisman JA, Rybicki FJ, Woodard PK. Medical 3D Printing Cost-Savings in Orthopedic and Maxillofacial Surgery: Cost Analysis of Operating Room Time Saved with 3D Printed Anatomic Models and Surgical Guides. Acad Radiol. 2020 Aug;27(8):1103-1113. doi: 10.1016/j.acra.2019.08.011. Epub 2019 Sep 18.

    PubMed 31542197

  • Barsella, R. (2020). Pilot Study: Educational Tool Reduces Parental Stress at Home Post Pediatric Cardiac Surgery.

  • Bhatla P, Tretter JT, Ludomirsky A, Argilla M, Latson LA Jr, Chakravarti S, Barker PC, Yoo SJ, McElhinney DB, Wake N, Mosca RS. Utility and Scope of Rapid Prototyping in Patients with Complex Muscular Ventricular Septal Defects or Double-Outlet Right Ventricle: Does it Alter Management Decisions? Pediatr Cardiol. 2017 Jan;38(1):103-114. doi: 10.1007/s00246-016-1489-1. Epub 2016 Nov 11.

    PubMed 27837304

  • Bibb, R., Eggbeer, D., & Paterson, A. (2014). Medical modelling: the application of advanced design and rapid prototyping techniques in medicine: Woodhead Publishing.

  • Biber S, Andonian C, Beckmann J, Ewert P, Freilinger S, Nagdyman N, Kaemmerer H, Oberhoffer R, Pieper L, Neidenbach RC. Current research status on the psychological situation of parents of children with congenital heart disease. Cardiovasc Diagn Ther. 2019 Oct;9(Suppl 2):S369-S376. doi: 10.21037/cdt.2019.07.07.

    PubMed 31737543

  • Bouma BJ, Mulder BJ. Changing Landscape of Congenital Heart Disease. Circ Res. 2017 Mar 17;120(6):908-922. doi: 10.1161/CIRCRESAHA.116.309302.

    PubMed 28302739

  • Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20.

    PubMed 28630973

  • Boyer PJ, Yell JA, Andrews JG, Seckeler MD. Anxiety reduction after pre-procedure meetings in patients with CHD. Cardiol Young. 2020 Jul;30(7):991-994. doi: 10.1017/S1047951120001407. Epub 2020 Jun 5.

    PubMed 32500844

  • Bruning J, Kramer P, Goubergrits L, Schulz A, Murin P, Solowjowa N, Kuehne T, Berger F, Photiadis J, Weixler VH. 3D modeling and printing for complex biventricular repair of double outlet right ventricle. Front Cardiovasc Med. 2022 Nov 30;9:1024053. doi: 10.3389/fcvm.2022.1024053. eCollection 2022.

    PubMed 36531701

Questions about this trial

What is this clinical trial studying?

A study testing Surgical Simulation with 3D Heart Model and Parental Education with "Congenital Heart Disease Parent Education Booklet" and tailored 3D Heart Modeling in people with Congenital Heart Disease, run by Yeditepe University 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact AYLIN AKCA SUMENGEN, PhD (5458411453, aylnakca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pretest-Family Impacts Module of the Pediatric Quality of Life Inventory PedsQL (time frame: 1 week prior to surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05852106, which also lists 51 linked publications.

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 10 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in