Satisfaction With an In-house Developed Nasal Foreign Body Removal Manikin

Sponsor

Prince of Songkla University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04901026

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To overcome the issues regarding training in real persons, using a simulated manikin instead of an actual patient or simulated patient is another option with consideration to the training able to be held at any time periods and no issues about minor or serious complications needed to be concerned with. The aim of this study is to devise a low-cost manikin with a specific design to serve all possible needs of end users but still keep its function as necessary for training.

Condition or Disease	Intervention/Treatment	Phase
Satisfaction Consumer Satisfaction	Other: An in-house manikin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Satisfaction With an In-house Developed Nasal Foreign Body Removal Manikin: A Randomized-controlled Trial

Anticipated Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

Sep 20, 2021

Anticipated Study Completion Date :

Nov 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: An in-house manikin Participants use an in-house manikin	Other: An in-house manikin Participants obtain an in-house manikin
Sham Comparator: A manikin in market Participants use a manikin from market	Other: An in-house manikin Participants obtain an in-house manikin

Arm

Intervention/Treatment

Active Comparator: An in-house manikin

Participants use an in-house manikin

Other: An in-house manikin

Participants obtain an in-house manikin

Sham Comparator: A manikin in market

Participants use a manikin from market

Other: An in-house manikin

Participants obtain an in-house manikin

Outcome Measures

Primary Outcome Measures

Satisfaction scores [3 months]
Satisfaction scores in different manikins using a 5-point Likert scale (1-very unsatisfied to 5- very satisfied). There are a number of scale titles including proper size, proper weight, the ease of use, the ease of cleaning, the ease of maintenance, the flexibility of nasal alae relative to actual anatomy, similarity of the nasal cavity relative to actual anatomy, a well design for teaching, estimated price, participant's confidence if a manikin can upskill medical students to practice in a real patient and overall satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Physicians who hold a MD degree

Exclusion Criteria:

Not want to complete questionnaires
No experience in a nasal foreign body removal

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Prince of Songkla University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pittayapon Pitathawatchai, Assistant professor, Prince of Songkla University

ClinicalTrials.gov Identifier:

NCT04901026

Other Study ID Numbers:

64-019-13-1

First Posted:

May 25, 2021

Last Update Posted:

May 26, 2021

Last Verified:

May 1, 2021

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 Pittayapon Pitathawatchai, Assistant professor, Prince of Songkla University

manikin

nasal foreign body

Additional relevant MeSH terms:

Foreign Bodies

Study Results

No Results Posted as of May 26, 2021