Trial Outcomes & Findings for Satisfaction With an In-house Developed Nasal Foreign Body Removal Manikin (NCT NCT04901026)

NCT ID: NCT04901026

Last Updated: 2024-04-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: 1 day for each manikin
• Results posted on: 2024-04-29

Participant Flow

Participant milestones

Measure	In-house Manikin First, Then Market Manikin 19 participants performed the nasal foreign body removal procedure using the in-house manikin. Later, they performed exactly the same procedure using the market manikin immediately after the in-house manikin.	Market Manikin First, Then In-house Manikin 18 participants performed the nasal foreign body removal procedure using the market manikin. Later, they performed exactly the same procedure using the in-house manikin immediately after the market manikin.
Overall Study STARTED	19	18
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	In-house Manikin First, Then Market Manikin n=19 Participants 19 participants performed the nasal foreign body removal procedure using the in-house manikin. Later, they performed exactly the same procedure using the market manikin immediately after the in-house manikin.	Market Manikin First, Then In-house Manikin n=18 Participants 18 participants performed the nasal foreign body removal procedure using the market manikin. Later, they performed exactly the same procedure using the in-house manikin immediately after the market manikin.	Total n=37 Participants Total of all reporting groups
Age, Continuous	30 years n=19 Participants	30 years n=18 Participants	30 years n=37 Participants
Sex: Female, Male Female	9 Participants n=19 Participants	8 Participants n=18 Participants	17 Participants n=37 Participants
Sex: Female, Male Male	10 Participants n=19 Participants	10 Participants n=18 Participants	20 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Thailand	19 Participants n=19 Participants	18 Participants n=18 Participants	37 Participants n=37 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	The In-house Manikin n=37 Participants participants who performed the nasal foreign body removal procedure using the in-house manikin.	The Market Manikin n=37 Participants participants who performed the nasal foreign body removal procedure using the market manikin.
Satisfaction Scores the ease of use	5 score on a scale Interval 1.0 to 5.0	4 score on a scale Interval 1.0 to 5.0
Satisfaction Scores the ease of maintenance	5 score on a scale Interval 1.0 to 5.0	3 score on a scale Interval 1.0 to 5.0
Satisfaction Scores proper size	4 score on a scale Interval 1.0 to 5.0	4 score on a scale Interval 1.0 to 5.0
Satisfaction Scores proper weight	4 score on a scale Interval 1.0 to 5.0	4 score on a scale Interval 1.0 to 5.0
Satisfaction Scores the ease of cleaning	4 score on a scale Interval 1.0 to 5.0	4 score on a scale Interval 1.0 to 5.0
Satisfaction Scores the flexibility of nasal alae	4 score on a scale Interval 1.0 to 5.0	3 score on a scale Interval 1.0 to 5.0
Satisfaction Scores similarity of nasal cavity	4 score on a scale Interval 1.0 to 5.0	3 score on a scale Interval 1.0 to 5.0
Satisfaction Scores a well design for teaching	4 score on a scale Interval 1.0 to 5.0	4 score on a scale Interval 1.0 to 5.0
Satisfaction Scores confidence that the manikin can upskill medical students	4 score on a scale Interval 1.0 to 5.0	4 score on a scale Interval 1.0 to 5.0

Adverse Events

The In-house Manikin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

The Market Manikin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Pittayapon Pitathawatchai

Faculty of Medicine, Prince of Songkla University

Phone: +6674451390

Email: pittayapon.p@psu.ac.th

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place