ClinicalTrials.gg
CompletedNCT04901026Updated Apr 29, 2024Results posted

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

An interventional study of An in-house manikin in Satisfaction and Consumer Satisfaction, sponsored by Prince of Songkla University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Prince of Songkla University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Satisfaction
  • Consumer Satisfaction

Keywords

  • manikin
  • nasal foreign body
03

In context

Personal Satisfaction

541 studies on the registry are indexed under Personal Satisfaction; 93 are open to participants now.

This study's enrollment of 37 is below the median of 93 across 416 interventional studies indexed under Personal Satisfaction.

Browse Personal Satisfaction studies →

Lead sponsor

Prince of Songkla University is the lead sponsor of 116 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Physicians who hold a MD degree

Exclusion criteria

Exclusion Criteria:

  • Not want to complete questionnaires
  • No experience in a nasal foreign body removal
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    An in-house manikin

    Participants use an in-house manikin

    Other: An in-house manikin

  • Sham comparator
    A manikin in market

    Participants use a manikin from market

    Other: An in-house manikin

Interventions

  • OtherAn in-house manikin

    Participants obtain an in-house manikin

06

What researchers measure

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.

    Time frame: 1 day for each manikin

07

Results

Posted Apr 29, 2024

Participant flow

Participant flow — Overall Study
MilestoneIn-house Manikin First, Then Market ManikinMarket Manikin First, Then In-house Manikin
Started1918
Completed1918
Not completed00

Outcome measures

PrimarySatisfaction 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.

Time frame:
1 day for each manikin
Reported as:
Median · score on a scale
Satisfaction Scores
score on a scaleThe In-house ManikinThe Market Manikin
proper size4 (1 to 5)4 (1 to 5)
proper weight4 (1 to 5)4 (1 to 5)
the ease of use5 (1 to 5)4 (1 to 5)
the ease of cleaning4 (1 to 5)4 (1 to 5)
the ease of maintenance5 (1 to 5)3 (1 to 5)
the flexibility of nasal alae4 (1 to 5)3 (1 to 5)
similarity of nasal cavity4 (1 to 5)3 (1 to 5)
a well design for teaching4 (1 to 5)4 (1 to 5)
confidence that the manikin can upskill medical students4 (1 to 5)4 (1 to 5)

Adverse events

Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
The In-house Manikin0/37 (0%)0/37 (0%)0/37 (0%)
The Market Manikin0/37 (0%)0/37 (0%)0/37 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)In-house Manikin First, Then Market ManikinMarket Manikin First, Then In-house ManikinTotal
Median30 (24 to 57)30 (24 to 57)30 (24 to 57)
Sex: Female, Male
Sex: Female, Male(Participants)In-house Manikin First, Then Market ManikinMarket Manikin First, Then In-house ManikinTotal
Female9817
Male101020
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)In-house Manikin First, Then Market ManikinMarket Manikin First, Then In-house ManikinTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(Participants)In-house Manikin First, Then Market ManikinMarket Manikin First, Then In-house ManikinTotal
Thailand191837
08

Study locations

1 site
  • Faculty of Medicine, Prince of Songkla University
    Hat Yai, Songkhla 90110, Thailand
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2021 to primary completion in Jul 2021, 0 months.

Results were first posted in Apr 2024, 2 years 9 months after primary completion.

Of 248 non-industry interventional studies with no phase under Personal Satisfaction, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 0 months is below that.

Counting every sponsor, half of 255 studies reached it within 9 months; a quarter within 3 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2021
First posted
May 25, 2021
StartActual
Jun 11, 2021
Primary completionActual
Jul 2, 2021
CompletionActual
Jul 2, 2021
Results first posted
Apr 29, 2024
Last update
Apr 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04901026
Responsible party
Pittayapon Pitathawatchai (Assistant professor, Prince of Songkla University) — Principal investigator
First posted
May 25, 2021
Start date
Jun 11, 2021
Primary completion
Jul 2, 2021
Completion
Jul 2, 2021
Results posted
Apr 29, 2024
Last update
Apr 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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