Effectiveness of Two Simulation-Based Functional Nasopharyngoscopic Velopharyngeal Assessment Trainings

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.

Study Overview

• Status: Completed
• Conditions: Simulation Training
• Intervention / Treatment: Behavioral: Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model; Behavioral: Nasopharyngoscopic Velopharyngeal Training with Ready-Made Endoscopy Training Model

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34810
    • İstanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 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 hands-on training on the ready-made endoscopy training model, under the guidance of the principal investigator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	2 Months
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.	2 Months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: simulation; speech and language therapy; nasopharyngoscopy training
• Other Study ID Numbers: MEDIPOL-SLT-BIROL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No