NCT05732376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

January 28, 2023

Last Update Submit

October 18, 2023

Conditions

Keywords

simulationnasopharyngoscopy trainingspeech and language therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Procedure time

    2 Months

  • Volunteer Experience for Nasopharyngoscopic Velopharyngeal Evaluation

    2 Months

  • Training Satisfaction Survey

    2 Months

Study Arms (2)

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

Interventions

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.

3D Printed Endoscopy Training Model Group

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.

Ready-Made Endoscopy Training Model Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Communication Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Namık Y. Birol, Doctoral Student

    Istanbul Medipol University, Institute of Health Sciences, Department of Speech and Language Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 17, 2023

Study Start

February 1, 2023

Primary Completion

July 10, 2023

Study Completion

July 10, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations