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Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy

Pragmatic Randomised Controlled Trial Assessing the Use of a Simple Distraction Technique to Reduce Discomfort When Performing Transnasal Fiberoptic Laryngoscopy in the ENT Outpatient Clinic

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03191370
Enrollment
40
Registered
2017-06-19
Start date
2021-03-08
Completion date
2022-12-01
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

pain during laryngoscopy, Flexible nasal endoscopy

Brief summary

To compare the effectiveness of reducing discomfort during flexible nasal endoscopy using simple distraction techniques compared to topical anaesthetic spray and a control group that does not receive topical anaesthetic spray or a distraction technique.

Detailed description

In this randomised controlled study patients will be randomly allocated into one of four groups; the first group will receive topical (co-phenylcaine) anaesthetic spray without distraction, the second group will receive topical (co-phenylcaine) anaesthetic spray with distraction, the thirds group will receive no topical (co-phenylcaine) anaesthetic spray without distraction and the fourth group will receive no topical (co-phenylcaine) anaesthetic spray with distraction. The distraction technique that will be employed is counting backwards from 30 to 1 in even numbers only. All flexible nasal endoscopies will be performed by either of the two most senior clinicians involved in the study. The procedure will be carried out in standard outpatient clinic room setting. Post procedural discomfort assessments will be undertaken using a visual analogue scale (VAS). Power calculations shows that \>24 patients would result in an adequately powered study (\>80%). Data analysis will be undertaken by SPSS and independent T-tests will be performed to assess for statistical significance.

Interventions

OTHERSimple distraction technique

Asking the patient to count backwards from 30 to1 in even numbers whilst the procedure is being performed.

Anesthetic spray

Sponsors

United Lincolnshire Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Male and Female participants aged 18+ * Patient requires flexible fiberoptic transnasal laryngoscopy. * Patient has no preferences in relation to which arm of the study they would like to be in.

Exclusion criteria

* Flexible nasal endoscopy not indicated * Local anaesthetic required for other reasons - e.g. vasoconstrictor effects * Patient has a clear preference to which group they are randomised to * Significant sino-nasal disease * Patient under the age of 18

Design outcomes

Primary

MeasureTime frameDescription
Discomfort during procedure5 minutesVisual analogue discomfort scale

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026