Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001751167
Ethics application status
Approved
Date submitted
15/08/2019
Date registered
10/12/2019
Date last updated
10/12/2019
Date data sharing statement initially provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Audiovisual distraction in nasal upper gastrointestinal endoscopy.
Scientific title
Audiovisual distraction vs No audiovisual distraction for managing anxiety in nasal upper gastrointestinal endoscopy.
Secondary ID [1] 298920 0
None
Universal Trial Number (UTN)
U1111-1238-0807
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic refractory gastroesophagical reflux 313902 0
Condition category
Condition code
Oral and Gastrointestinal 312315 312315 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A video consisting of various images and audio that stimulates patient relaxation will be reproduced by the operator and co-investigator of the study, during the nasal endoscopic procedure, which lasts around 40 minutes.
For the reproduction of the video, a virtual reality viewer, called Oculus Go (Facebook Technologies, LLC), will be used, in addition to hearing aids with surround sound. The video and sound content were created with copyright-free audiovisual material, in which landscape images and relaxation music are played throughout the whole procedure.
Also, the explanation video will be reproduced before the nasal endoscopy procedure.
Intervention code [1] 315202 0
Treatment: Other
Comparator / control treatment
Brief explanation of the nasal endoscopy procedure, with video images and audio-guided description, will be reproduced before the nasal endoscopy procedure.
Control group
Active

Outcomes
Primary outcome [1] 320950 0
To compare the anxiety score, measured by Beck Anxiety Scale in the interventional vs control group during the nasal endoscopy procedure.
Timepoint [1] 320950 0
30 minutes post nasal endoscopy procedure.
Primary outcome [2] 321828 0
To compare the anxiety score, measured by Patient Health Questionnaire (PCSQ-9), in the interventional vs control group during the nasal endoscopy procedure.
Timepoint [2] 321828 0
30 minutes post nasal endoscopy procedure.
Secondary outcome [1] 373478 0
To compare the number of successful completed nasal endoscopy procedures assessed by localization and reaching the esophagus, stomach and duodenal portions of the gastrointestinal tract during the nasal endoscopy, in the interventional vs control group 30 minutes post nasal endoscopy procedure.
Timepoint [1] 373478 0
30 minutes post nasal endoscopy procedure.

Eligibility
Key inclusion criteria
Patients with the following criteria will be included in the study:
Male or female, 18-65 years of age,
Globus,
Symptomatology of chronic refractory reflux to pharmacological therapy,
Dyspeptic syndrome without alarm data,
Non-cardiac chest pain.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with the following criteria will be excluded from the study:
Dysphagia,
Alarm signs (weight loss, etc.),
History of food impact,
Previous use of aspirin or anticoagulants (3 months),
History of recurrent epistaxis,
History of nasal trauma,
Chronic sinusitis,
Previous nasal surgeries,
Highly anxious patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software generated by radioactive decay.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The calculated sample was determined by the ratio difference formula resulting in 54 patients, taking as reference a power of 80% and alpha of 5. The data will be reported as mean and standard deviation or median and range, accordingly to data normality distribution. To compare the standard deviation, a Fischer test will be applied in the correlation of coefficients. Confidence intervals of 95% will be used. Evaluation of qualitative variables through Chi square (tables 2x2 or 2x3) where the difference was established when the p was less than or equal to 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
Date of last participant enrolment
Anticipated
2/03/2020
Actual
Date of last data collection
Anticipated
27/03/2020
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment outside Australia
Country [1] 21742 0
Mexico
State/province [1] 21742 0
Nuevo Leon

Funding & Sponsors
Funding source category [1] 303467 0
Hospital
Name [1] 303467 0
Hospital Universitario, Dr. José E. González, Universidad Autónoma de Nuevo León
Country [1] 303467 0
Mexico
Primary sponsor type
Hospital
Name
Hospital Universitario, Dr. José E. González, Universidad Autónoma de Nuevo León
Address
Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country
Mexico
Secondary sponsor category [1] 303525 0
None
Name [1] 303525 0
Address [1] 303525 0
Country [1] 303525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303997 0
Hospital Universitario and Medicine Faculty Ethics Committee
Ethics committee address [1] 303997 0
Ethics committee country [1] 303997 0
Mexico
Date submitted for ethics approval [1] 303997 0
01/03/2019
Approval date [1] 303997 0
13/05/2019
Ethics approval number [1] 303997 0
G19-0001

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95498 0
Dr Daniel Eduardo Benavides Salgado
Address 95498 0
Hospital Universitario, "Dr Jose E. Gonzalez", Facultad de Medicina, Universidad Autónoma de Nuevo Leon, Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country 95498 0
Mexico
Phone 95498 0
+52 81 8389 1111
Fax 95498 0
Email 95498 0
[email protected]
Contact person for public queries
Name 95499 0
Hector Raul Ibarra Sifuenets
Address 95499 0
Hospital Universitario, "Dr Jose E. Gonzalez", Facultad de Medicina, Universidad Autónoma de Nuevo Leon, Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country 95499 0
Mexico
Phone 95499 0
+52 81 8389 1111
Fax 95499 0
Email 95499 0
[email protected]
Contact person for scientific queries
Name 95500 0
Hector Raul Ibarra Sifuentes
Address 95500 0
Hospital Universitario, "Dr Jose E. Gonzalez", Facultad de Medicina, Universidad Autónoma de Nuevo Leon, Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country 95500 0
Mexico
Phone 95500 0
+52 81 8389 1111
Fax 95500 0
Email 95500 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who contact the corresponding author.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Anxiety scores and successful competition nasal endoscopy procedures in the control and intervention group.

What types of analyses could be done with individual participant data?
• Statistical

When can requests for individual participant data be made (start and end dates)?
From:
From January 30th 2020 to December 30th 2020.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by by emailing the principal investigator at [email protected].

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.