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

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

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.

Study Overview

• Status: Completed
• Conditions: Satisfaction; Consumer Satisfaction
• Intervention / Treatment: Other: An in-house manikin

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Faculty of Medicine, Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Physicians who hold a MD degree

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): July 2, 2021
• Study Completion (Actual): July 2, 2021

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: manikin; nasal foreign body
• Additional Relevant MeSH Terms: Wounds and Injuries; Foreign Bodies
• Other Study ID Numbers: 64-019-13-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No