Trials / Completed
CompletedNCT03191370
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- United Lincolnshire Hospitals NHS Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Simple distraction technique | Asking the patient to count backwards from 30 to1 in even numbers whilst the procedure is being performed. |
| DRUG | Local Anesthetics,Topical | Anesthetic spray |
Timeline
- Start date
- 2021-03-08
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2017-06-19
- Last updated
- 2023-02-08
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03191370. Inclusion in this directory is not an endorsement.