Simulation TrainingNCT05732376
Effectiveness of Two Simulation-Based Functional Nasopharyngoscopic Velopharyngeal Assessment Trainings
A study testing Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model and Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training Model in people with Simulation Training, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial was to compare the effectiveness of functional nasopharyngoscopic velopharyngeal assessment training given to undergraduate speech and language therapy students on a 3D printed endoscopy training model and a ready-made endoscopy training model. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation Training
- What is being tested?
- Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model and Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 10 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be a 4th year undergraduate student of speech and language therapy
- To have taken the course of cleft lip and palate or an equivalent course
Who cannot join
- Receiving previous hand-on flexible endoscopy training
- Having any health problem in the upper extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Simulation-Based Functional Nasopharyngoscopic Velopharyngeal Assessment Trainings Given to Speech and Language Therapy Students
The aim of this clinical trial was to compare the effectiveness of functional nasopharyngoscopic velopharyngeal assessment training given to undergraduate speech and language therapy students on a 3D printed endoscopy training model and a ready-made endoscopy training model.
- Conditions
- Simulation Training
- Being tested
- Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model, Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training Model
- Keywords
- simulation, nasopharyngoscopy training, speech and language therapy
- Medical subject headings
- Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training ModelBehavioural
Theoretical training: The theoretical training covers the anatomy and physiology of the velopharyngeal region and nasal cavity, nasopharyngoscope, preparation of the patient for nasopharyngoscopy, use of the endoscope during nasopharyngoscopy and the procedure for nasopharyngoscopic velopharyngeal function assessment.
Practical training: At the beginning of the hands-on training, the device will be introduced to the participants. Basic information will be given about endoscopy device. Then, the principal investigator will give information about the use of the endoscope (patient instructions, holding the endoscope, placement of the endoscope in the nose, manipulation of the endoscope, anatomical structures in the nasal cavity and velopharyngeal region, velopharyngeal function assessment) on the 3D printed endoscopy training model. Participants will receive hands-on training on the 3D printed endoscopy training model, under the guidance of the principal investigator.
Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training ModelBehavioural
Theoretical training: The theoretical training covers the anatomy and physiology of the velopharyngeal region and nasal cavity, nasopharyngoscope, preparation of the patient for nasopharyngoscopy, use of the endoscope during nasopharyngoscopy and the procedure for nasopharyngoscopic velopharyngeal function assessment.
Practical training: At the beginning of the hands-on training, the device will be introduced to the participants. Basic information will be given about endoscopy device. Then, the principal investigator will give information about the use of the endoscope (patient instructions, holding the endoscope, placement of the endoscope in the nose, manipulation of the endoscope, anatomical structures in the nasal cavity and velopharyngeal region, velopharyngeal function assessment) on the ready-made endoscopy training model. Participants will receive hands-on training on the ready-made endoscopy training model, under the guidance of the principal investigator.
| Study group | Role | What they receive |
|---|---|---|
| 3D Printed Endoscopy Training Model Group | Experimental | Not described Receives: Behavioral: Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model |
| Ready-Made Endoscopy Training Model Group | Active comparator | Not described Receives: Behavioral: Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasopharyngoscopic Velopharyngeal Evaluation Clinician Experience
A 9-question perceptual survey was created to evaluate the participants' self-confidence and self-competence in performing nasopharyngoscopic velopharyngeal evaluation. The survey was adapted from a 5-point Likert-type survey previously used in simulation-based transnasal endoscopy training on swallowing assessment (Benadom \& Potter, 2011).
Measured: 2 Months
Secondary outcomes (3)
Procedure time
This is the time from the moment the endoscope enters the nostril until it reaches the point of visualization of the velopharyngeal sphincter. This time does not include the time the endoscope is removed from the nose and reinserted.
Measured: 2 Months
Volunteer Experience for Nasopharyngoscopic Velopharyngeal Evaluation
A 6-question survey was created to allow volunteers to perceptually assess the competence and confidence of the clinician after the endoscope was administered to the volunteers. The survey was adapted from a 5-point Likert-type survey previously used in simulation-based transnasal endoscopy training in swallowing assessment (Benadom \& Potter, 2011).
Measured: 2 Months
Training Satisfaction Survey
A training satisfaction survey consisting of a total of 7 questions (four Likert-type and three open-ended question) was created to learn the evaluations of the participants regarding the importance, effectiveness, appropriateness and satisfaction level of the simulation trainings. The survey was adapted from the form created by Uz-Hasırcı (2020).
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Feb 2023
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation TrainingStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namık Yücel Birol, Medipol University
- Investigators
- Namık Y. Birol, Doctoral Student, Principal investigator, Istanbul Medipol University, Institute of Health Sciences, Department of Speech and Language Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732376
- Sponsor's protocol ID
- MEDIPOL-SLT-BIROL-001
- Status last verified
- Oct 2023
- First submitted
- 28 Jan 2023
- Last updated
- 19 Oct 2023
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Simulation-Based Functional Nasopharyngoscopic Velopharyngeal Assessment Trainings Given to Speech and Language Therapy Students
- ClinicalTrials.gov ID
- NCT05732376
- Acronym / sponsor ID
- MEDIPOL-SLT-BIROL-001
- Conditions
- Simulation Training
- Keywords
- simulation, nasopharyngoscopy training, speech and language therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 17 Feb 2023 (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.
The aim of this clinical trial was to compare the effectiveness of functional nasopharyngoscopic velopharyngeal assessment training given to undergraduate speech and language therapy students on a 3D printed endoscopy training model and a ready-made endoscopy training model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Printed Endoscopy Training Model Group | Experimental | Behavioral: Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model |
| Ready-Made Endoscopy Training Model Group | Active comparator | Behavioral: Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training Model |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- To be a 4th year undergraduate student of speech and language therapy
- To have taken the course of cleft lip and palate or an equivalent course
Key exclusion criteria (2 listed)
- Receiving previous hand-on flexible endoscopy training
- Having any health problem in the upper extremities
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 |
|---|---|---|
| Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training ModelTheoretical training: The theoretical training covers the anatomy and physiology of the velopharyngeal region and nasal cavity, nasopharyngoscope, preparation of the patient for nasopharyngoscopy, use of the endoscope during nasopharyngoscopy and the procedure for nasopharyngoscopic velopharyngeal function assessment. Practical training: At the beginning of the hands-on training, the device will be introduced to the participants. Basic information will be given about endoscopy device. Then, the principal investigator will give information about the use of the endoscope (patient instructions, holding the endoscope, placement of the endoscope in the nose, manipulation of the endoscope, anatomical structures in the nasal cavity and velopharyngeal region, velopharyngeal function assessment) on the 3D printed endoscopy training model. Participants will receive hands-on training on the 3D printed endoscopy training model, under the guidance of the principal investigator. | Behavioural | 3D Printed Endoscopy Training Model Group |
| Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training ModelTheoretical training: The theoretical training covers the anatomy and physiology of the velopharyngeal region and nasal cavity, nasopharyngoscope, preparation of the patient for nasopharyngoscopy, use of the endoscope during nasopharyngoscopy and the procedure for nasopharyngoscopic velopharyngeal function assessment. Practical training: At the beginning of the hands-on training, the device will be introduced to the participants. Basic information will be given about endoscopy device. Then, the principal investigator will give information about the use of the endoscope (patient instructions, holding the endoscope, placement of the endoscope in the nose, manipulation of the endoscope, anatomical structures in the nasal cavity and velopharyngeal region, velopharyngeal function assessment) on the ready-made endoscopy training model. Participants will receive hands-on training on the ready-made endoscopy training model, under the guidance of the principal investigator. | Behavioural | Ready-Made Endoscopy Training Model Group |
Primary outcome
Nasopharyngoscopic Velopharyngeal Evaluation Clinician Experience
Time frame: 2 Months
A 9-question perceptual survey was created to evaluate the participants' self-confidence and self-competence in performing nasopharyngoscopic velopharyngeal evaluation. The survey was adapted from a 5-point Likert-type survey previously used in simulation-based transnasal endoscopy training on swallowing assessment (Benadom \& Potter, 2011).
3 secondary outcomes
Procedure time
Time frame: 2 Months
Volunteer Experience for Nasopharyngoscopic Velopharyngeal Evaluation
Time frame: 2 Months
Training Satisfaction Survey
Time frame: 2 Months
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 19 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Simulation Training
Not yet recruiting
Model-Based Episiotomy Training
Episiotomy
Not yet recruiting
Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
Cardiac Arrest, Cardiopulmonary Resuscitation
Active, not recruiting
Enhancing Male Nursing Students' Competence in Maternity Care: A Quasi-Experimental Study in Egypt
Maternity Nursing, Obstetric Nursing
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Enrolling by invitation
Virtual Reality-Based Simulation Training for Retrograde Anterior Column Acetabular Screw Placement in Orthopedic Residents
Virtual Reality Simulation
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.
Namık Y. Birol, Doctoral Student principal investigator
Istanbul Medipol University, Institute of Health Sciences, Department of Speech and Language Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model and Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training Model in people with Simulation Training, run by Medipol 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 2 inclusion and 2 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 19 Oct 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?
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?
Nasopharyngoscopic Velopharyngeal Evaluation Clinician Experience (time frame: 2 Months). 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 19 Oct 2023.