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Completed

NCT Number: NCT05732376

Effectiveness of Two Simulation-Based Functional Nasopharyngoscopic Velopharyngeal Assessment Trainings

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.

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Key information

Conditions

Simulation Training Communication Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasopharyngoscopic Velopharyngeal Training with 3D Printed Endoscopy Training Model

Behavioral

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 Model

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Procedure time

    Time frame: 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.

  2. Volunteer Experience for Nasopharyngoscopic Velopharyngeal Evaluation

    Time frame: 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).

  3. Training Satisfaction Survey

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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