NCT04901026

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

June 11, 2021

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 29, 2024

Completed
Last Updated

April 29, 2024

Status Verified

November 1, 2023

Enrollment Period

21 days

First QC Date

May 20, 2021

Results QC Date

September 26, 2022

Last Update Submit

November 18, 2023

Conditions

Keywords

manikinnasal foreign body

Outcome Measures

Primary Outcomes (1)

  • Satisfaction Scores

    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.

    1 day for each manikin

Study Arms (2)

An in-house manikin

ACTIVE COMPARATOR

Participants use an in-house manikin

Other: An in-house manikin

A manikin in market

SHAM COMPARATOR

Participants use a manikin from market

Other: An in-house manikin

Interventions

Participants obtain an in-house manikin

A manikin in marketAn in-house manikin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physicians who hold a MD degree

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Personal SatisfactionConsumer Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr Pittayapon Pitathawatchai
Organization
Faculty of Medicine, Prince of Songkla University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

June 11, 2021

Primary Completion

July 2, 2021

Study Completion

July 2, 2021

Last Updated

April 29, 2024

Results First Posted

April 29, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations