PainNCT03191370
Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy
A study testing Simple distraction technique and Local Anesthetics,Topical in people with Pain, run by United Lincolnshire Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Simple distraction technique and Local Anesthetics,Topical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Mar 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
United Lincolnshire Hospitals Trust
Lincoln, Research Manager, LN57XD
About this study
Official title: 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
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.
Read the 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
- Pain
- Being tested
- Simple distraction technique, Local Anesthetics,Topical
- Keywords
- pain during laryngoscopy, Flexible nasal endoscopy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple distraction techniqueOther
Asking the patient to count backwards from 30 to1 in even numbers whilst the procedure is being performed.
Local Anesthetics,TopicalDrug
Also called Co-phenylcaine
Anesthetic spray
| Study group | Role | What they receive |
|---|---|---|
| Local Anaesthetic, no distraction | Active comparator | Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) as an active comparator without distraction during the procedure. Receives: Drug: Local Anesthetics,Topical |
| Local Anaesthetic, with distraction | Experimental | Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) with distraction during the procedure. The simple distraction technique is the experimental intervention. Receives: Other: Simple distraction technique; Drug: Local Anesthetics,Topical |
| No Local Anaesthetic without distraction | No intervention | Will receive no local (co-phenylcaine) anaesthetic spray without distraction during the procedure. |
| No Local Anaesthetic, with distraction | Experimental | Will receive no local (co-phenylcaine) anesthetic spray with distraction during the procedure. The simple distraction technique is the experimental intervention. Receives: Other: Simple distraction technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort during procedure
Visual analogue discomfort scale
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start8 Mar 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Lincolnshire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faisal A Arshad, MRCS, Principal investigator, United Lincolnshire NHS trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191370
- Sponsor's protocol ID
- 280217ArshadFaisal
- Status last verified
- Feb 2023
- First submitted
- 7 Jun 2017
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conlin AE, McLean L. Systematic review and meta-analysis assessing the effectiveness of local anesthetic, vasoconstrictive, and lubricating agents in flexible fibre-optic nasolaryngoscopy. J Otolaryngol Head Neck Surg. 2008 Apr;37(2):240-9.
PubMed 19128620Cain AJ, Murray DP, McClymont LG. The use of topical nasal anaesthesia before flexible nasendoscopy: a double-blind, randomized controlled trial comparing cophenylcaine with placebo. Clin Otolaryngol Allied Sci. 2002 Dec;27(6):485-8. doi: 10.1046/j.1365-2273.2002.00608.x.
PubMed 12472516Choudhury N, Amer I, Daniels M, Wareing MJ. Audiovisual distraction reduces pain perception during aural microsuction. Ann R Coll Surg Engl. 2013 Jan;95(1):34-6. doi: 10.1308/003588413X13511609955535.
PubMed 23317724Pothier DD, Raghava N, Monteiro P, Awad Z. A randomized controlled trial: is water better than a standard lubricant in nasendoscopy? Clin Otolaryngol. 2006 Apr;31(2):134-7. doi: 10.1111/j.1749-4486.2006.01173.x.
PubMed 16620333
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03191370
- Acronym / sponsor ID
- 280217ArshadFaisal
- Conditions
- Pain
- Keywords
- pain during laryngoscopy, Flexible nasal endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- United Lincolnshire Hospitals NHS TrustUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Local Anaesthetic, no distraction | Active comparator | Drug: Local Anesthetics,TopicalWill receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) as an active comparator without distraction during the procedure. |
| Local Anaesthetic, with distraction | Experimental | Other: Simple distraction technique, Drug: Local Anesthetics,TopicalWill receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) with distraction during the procedure. The simple distraction technique is the experimental intervention. |
| No Local Anaesthetic without distraction | No intervention | –Will receive no local (co-phenylcaine) anaesthetic spray without distraction during the procedure. |
| No Local Anaesthetic, with distraction | Experimental | Other: Simple distraction techniqueWill receive no local (co-phenylcaine) anesthetic spray with distraction during the procedure. The simple distraction technique is the experimental intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple distraction techniqueAsking the patient to count backwards from 30 to1 in even numbers whilst the procedure is being performed. | Other | Local Anaesthetic, with distraction, No Local Anaesthetic, with distraction |
| Local Anesthetics,TopicalAlso: Co-phenylcaineAnesthetic spray | Drug | Local Anaesthetic, no distraction, Local Anaesthetic, with distraction |
Primary outcome
Discomfort during procedure
Time frame: 5 minutes
Visual analogue discomfort scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 19128620Conlin AE, McLean L. Systematic review and meta-analysis assessing the effectiveness of local anesthetic, vasoconstrictive, and lubricating agents in flexible fibre-optic nasolaryngoscopy. J Otolaryngol Head Neck Surg. 2008 Apr;37(2):240-9.
- Background: PubMed 12472516Cain AJ, Murray DP, McClymont LG. The use of topical nasal anaesthesia before flexible nasendoscopy: a double-blind, randomized controlled trial comparing cophenylcaine with placebo. Clin Otolaryngol Allied Sci. 2002 Dec;27(6):485-8. doi: 10.1046/j.1365-2273.2002.00608.x.
- Background: PubMed 23317724Choudhury N, Amer I, Daniels M, Wareing MJ. Audiovisual distraction reduces pain perception during aural microsuction. Ann R Coll Surg Engl. 2013 Jan;95(1):34-6. doi: 10.1308/003588413X13511609955535.
- Background: PubMed 16620333Pothier DD, Raghava N, Monteiro P, Awad Z. A randomized controlled trial: is water better than a standard lubricant in nasendoscopy? Clin Otolaryngol. 2006 Apr;31(2):134-7. doi: 10.1111/j.1749-4486.2006.01173.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faisal A Arshad, MRCS principal investigator
United Lincolnshire NHS trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple distraction technique and Local Anesthetics,Topical in people with Pain, run by United Lincolnshire Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discomfort during procedure (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03191370, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.