NCT04901026

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

Completed NA Results posted Last updated 29 April 2024

What this trial tests

NA trial testing An in-house manikin in Satisfaction in 37 participants. Completed in 2 July 2021.

Timeline

11 June 2021

Primary endpoint
2 July 2021

2 July 2021

Quick facts

Lead sponsor	Prince of Songkla University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	37
Start date	11 June 2021
Primary completion	2 July 2021
Estimated completion	2 July 2021
Sites	1 location across Thailand

Drugs / interventions tested

• An in-house manikin

Conditions studied

• Satisfaction — all drugs for Satisfaction →
• Consumer Satisfaction — all drugs for Consumer Satisfaction →

Sponsor

Prince of Songkla University

Who can join

18 and older, any sex, with Satisfaction or Consumer Satisfaction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Satisfaction Scores Primary · 1 day for each manikin

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.

proper size

Group	Value	95% CI
The In-house Manikin	4	1 – 5
The Market Manikin	4	1 – 5

proper weight

Group	Value	95% CI
The In-house Manikin	4	1 – 5
The Market Manikin	4	1 – 5

the ease of use

Group	Value	95% CI
The In-house Manikin	5	1 – 5
The Market Manikin	4	1 – 5

the ease of cleaning

Group	Value	95% CI
The In-house Manikin	4	1 – 5
The Market Manikin	4	1 – 5

the ease of maintenance

Group	Value	95% CI
The In-house Manikin	5	1 – 5
The Market Manikin	3	1 – 5

the flexibility of nasal alae

Group	Value	95% CI
The In-house Manikin	4	1 – 5
The Market Manikin	3	1 – 5

similarity of nasal cavity

Group	Value	95% CI
The In-house Manikin	4	1 – 5
The Market Manikin	3	1 – 5

a well design for teaching

Group	Value	95% CI
The In-house Manikin	4	1 – 5
The Market Manikin	4	1 – 5

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Satisfaction with an In-House Nasal Foreign Body Removal Manikin: A Randomized Controlled Trial.
   Pitathawatchai P, Anuntaseree S, Yuenyongviwat V. · · 2021 · PMID 34447275 · DOI 10.2147/mder.s326575