Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Local Anaesthetic, no distraction

Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) as an active comparator without distraction during the procedure.

Group Type ACTIVE_COMPARATOR

Local Anesthetics,Topical

Intervention Type DRUG

Anesthetic spray

Local Anaesthetic, with distraction

Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) with distraction during the procedure. The simple distraction technique is the experimental intervention.

Group Type EXPERIMENTAL

Simple distraction technique

Intervention Type OTHER

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

Local Anesthetics,Topical

Intervention Type DRUG

Anesthetic spray

No Local Anaesthetic without distraction

Will receive no local (co-phenylcaine) anaesthetic spray without distraction during the procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

No Local Anaesthetic, with distraction

Will receive no local (co-phenylcaine) anesthetic spray with distraction during the procedure. The simple distraction technique is the experimental intervention.

Group Type EXPERIMENTAL

Simple distraction technique

Intervention Type OTHER

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

Interventions

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Simple distraction technique

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

Intervention Type OTHER

Local Anesthetics,Topical

Anesthetic spray

Intervention Type DRUG

Other Intervention Names

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Co-phenylcaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes