Effectiveness of Two Simulation-Based Functional Nasopharyngoscopic Velopharyngeal Assessment Trainings

Sponsor

Medipol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05732376

Collaborator

(none)

Enrollment

Location

Arms

4.9

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Simulation Training	Behavioral: Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model Behavioral: Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training Model	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Investigation of the Effectiveness of Simulation-Based Functional Nasopharyngoscopic Velopharyngeal Assessment Trainings Given to Speech and Language Therapy Students

Actual Study Start Date :

Feb 10, 2023

Anticipated Primary Completion Date :

Jul 10, 2023

Anticipated Study Completion Date :

Jul 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D Printed Endoscopy Training Model Group	Behavioral: Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model 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 10 minutes of hands-on training on the 3D printed endoscopy training model, under the guidance of the principal investigator.
Active Comparator: Ready-Made Endoscopy Training Model Group	Behavioral: Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training Model 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 10 minutes of hands-on training on the ready-made endoscopy training model, under the guidance of the principal investigator.

Arm

Intervention/Treatment

Experimental: 3D Printed Endoscopy Training Model Group

Behavioral: Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model

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 10 minutes of hands-on training on the 3D printed endoscopy training model, under the guidance of the principal investigator.

Active Comparator: Ready-Made Endoscopy Training Model Group

Behavioral: Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training Model

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 10 minutes of hands-on training on the ready-made endoscopy training model, under the guidance of the principal investigator.

Outcome Measures

Primary Outcome Measures

Nasopharyngoscopic Velopharyngeal Evaluation Clinician Experience [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).

Secondary Outcome Measures

Total procedure time [2 Months]
The time from the moment the endoscope enters the nostril to the point of visualization of the velopharyngeal sphincter. This time includes the time the endoscope is removed from the nose and reinserted.
Total time in the nose [2 Months]
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.
Volunteer Experience for Nasopharyngoscopic Velopharyngeal Evaluation [2 Months]
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).
Training Satisfaction Survey [2 Months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Receiving previous hand-on flexible endoscopy training
Having any health problem in the upper extremities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medipol University	Istanbul		Turkey	34810

Sponsors and Collaborators

Medipol University

Investigators

Principal Investigator: Namık Y. Birol, Doctoral Student, Istanbul Medipol University, Institute of Health Sciences, Department of Speech and Language Therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Namık Yücel Birol, Principal Investigator, Medipol University

ClinicalTrials.gov Identifier:

NCT05732376

Other Study ID Numbers:

MEDIPOL-SLT-BIROL-001

First Posted:

Feb 17, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Namık Yücel Birol, Principal Investigator, Medipol University

simulation

nasopharyngoscopy training

speech and language therapy

Study Results

No Results Posted as of Feb 21, 2023