Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000918820
Ethics application status
Approved
Date submitted
29/05/2021
Date registered
15/07/2021
Date last updated
5/07/2024
Date data sharing statement initially provided
15/07/2021
Date results provided
20/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Can examination of lower bowel by flexible telescope be made easier for patients by showing them a video about it and laughing gas to breathe?
Scientific title
Effects of a Familiarization Video & Patient–Controlled Entonox Inhalation on Patient Comfort & Clinical Efficacy of Elective Flexible Sigmoidoscopy; Assessment of the Feasibility & Acceptability of Combining these Two Treatments.
Secondary ID [1] 304349 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colonic lesions 322119 0
Rectal bleeding 322120 0
Condition category
Condition code
Oral and Gastrointestinal 319827 319827 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
Arm 2
• If participants wish they can view a 5 minute video, which has been specifically developed for this study, to familiarize themselves with what the flexible sigmoidoscopy (F/S) entails. This will be available for them to see for 2 days before the F/S over the Internet and also at the hospital whilst waiting to have their F/S. They do not need to watch the video if they do not wish to do so. They will be asked whether they watched the video but they will not be monitored to ensure they have done so.
• then fill in a self-administered survey questionnaire on whether the video was helpful and their anxiety level (about 8 minutes)
• then proceed the same as in Arm 1 with the same ECG monitor, F/S, discomfort/pain/satisfaction survey questionnaire and be allowed to leave the Canterbury Charity Hospital (CCH).

Arm 3
• They will be treated as Arm 2, with the same offer of watching the pre-F/S video, and the same surveys before the F/S and ECG monitoring
• At the beginning of F/S, however, they will be shown how to self-administer and control the use of a gas mixture to breathe called Entonox (laughing gas) that helps to relieve discomfort and pain and causes mild sleepiness. The dose of the Entonox that will be administered will be 50% nitrous oxide and 50% oxygen. This will be administered by a whistle/pen device. They will be able to freely choose whether, when and for how long they breathe this gas during their F/S. The number of times participants use the gas will be recorded and the volume of gas used measured post-procedure use a gas gauge.
• after that they fill in the same discomfort/pain/satisfaction survey questionnaire but be kept under observation at CCH for a minimum of 30 minutes, until any sleepiness from the gas wears off and they can be allowed to leave CCH.
Intervention code [1] 320703 0
Treatment: Drugs
Intervention code [2] 321156 0
Treatment: Other
Comparator / control treatment
Arm 1
• Will fill in a self-administered survey questionnaire on their anxiety level (taking 5 minutes)
• wear a miniaturized ECG monitor produced and studied by the Department of Mechanical Engineering, University of Canterbury.
• have a standard F/S with standard clinical monitoring
• afterwards fill in a self-administered survey questionnaire on how much discomfort and pain they had during the F/S, and their level of satisfaction with their care (taking about 8 minutes)
• be discharged home immediately after.
Control group
Active

Outcomes
Primary outcome [1] 327694 0
In Arms 2 and 3, after watching the video and before the procedure, the video questionnaire and self-assessment anxiety score form is administered . This based on a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (Marteau TM, Bekker H. Br J Clin Psychol. 1992;31(3):301-6). Two specifically designed questions were added to this scale to assess opinions on the video.
Timepoint [1] 327694 0
Administered once only after watching the video and pre-procedure.
Primary outcome [2] 327695 0
Nurse-Generated Participant Comfort Score. This score is derived from Ekkelenkamp VE, et al. Patient comfort and quality in colonoscopy. World J Gastroenterol 2013;19(15):2355-61.
Timepoint [2] 327695 0
Once, immediately at the end of the procedure.
Primary outcome [3] 327696 0
Discomfort scores. Measured by one question with a five-point Likert scale from the Participant-Generated Discomfort, Pain and Satisfaction Scores form designed specifically for the study .
Timepoint [3] 327696 0
15 minutes post-procedure and one month post-procedure.
Secondary outcome [1] 396248 0
Length of bowel examined is measured from the scale on the colonoscope as recorded on the endoscopy report written at the end of the procedure by the specialist endoscopist.
Timepoint [1] 396248 0
Intra-procedure
Secondary outcome [2] 396249 0
Number of colonic lesions detected as recorded in the endoscopy report written at the end of the procedure by the specialist endoscopist.
Timepoint [2] 396249 0
Intra-procedure
Secondary outcome [3] 396258 0
Heart rate variability using ECG as a monitor of anxiety
Timepoint [3] 396258 0
Immediately after giving written informed consent and before viewing the video the ECG monitor is started and assessed continuously until until 15 minutes post-procedure.
Secondary outcome [4] 397382 0
Change in pain as part of a primary outcome. Measured by one question with a five-point Likert scale from the Participant-Generated Discomfort, Pain and Satisfaction Scores form designed specifically for the study .
Timepoint [4] 397382 0
15 minutes after the procedure and one month after the procedure.
Secondary outcome [5] 397383 0
Change in Satisfaction score as a primary outcome. Measured by three questions each with five-point Likert scales from the Participant-Generated Discomfort, Pain and Satisfaction Scores form designed specifically for the study .
Timepoint [5] 397383 0
15 minute post-procedure and one month post-procedure.

Eligibility
Key inclusion criteria
Patients aged 18 to 50 years of age with outlet-type fresh rectal bleeding, referred from Canterbury District Health Board and Canterbury GPs because they do not reach the required threshold scores to qualify for lower GI endoscopy in the public hospital system.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unwilling or unable to give informed consent.
2. Significant medical co-morbidities (ASA 3 & 4).
3. Acute asthma or advanced COPD (O2 Stats < 94%)
4. History of pneumothorax.
5. Decompression sickness or recent dive.
6. Pulmonary hypertension.
7. Severe bone marrow depression or similar haematological disorders
e.g. homocysteinaemia.
8. During first trimester of pregnancy.
9. Middle ear disease or surgery.
10. Obstruction of sinus cavities
11. Recent eye surgery or gas injections.
12. Gross abdominal distension.
13. Any anticoagulant and anti-platelet medication or known bleeding diathesis.
14. Strong sedative or analgesic medication e.g. Benzodiazepines, opioids.
15. Vitamin B12 deficiency
16. Severe terminal disease or life expectance of less than 5 years.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed but pre-randomised in groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A cluster-randomised single centre three-block study design will be used, with each of the 3 study Arms replicated within each temporal block. Each study Arm will last for six weeks, so each of the three replicate blocks will take 18 weeks, with the sequence of the study Arms within each block randomly assigned. The 3 block sequence will be re-randomised and repeated until the requisite numbers of participants have been accrued in each of the 3 study Arms.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Fifty participants in each of the three Arms will give >80% power to show a 0.5 unit difference in the following scores as statistically significant (two-tailed alpha=0.025, allowing for the two comparisons with the control treatment group):
• Pre-procedure: Participant Anxiety Score
• Intra-procedure: Participant Comfort Score
• Post-procedure: Participant Discomfort, Pain and Satisfaction Scores
• One month later: repeat Participant Discomfort, Pain and Satisfaction Scores.
Participant data will be analyzed on an intention to treat basis. Therefore, for example, participants given the options to view the pre-F/S video will have their data combined for analysis regardless of whether or not they viewed the video.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2021
Actual
22/09/2021
Date of last participant enrolment
Anticipated
1/11/2022
Actual
16/10/2022
Date of last data collection
Anticipated
1/12/2022
Actual
17/11/2022
Sample size
Target
150
Accrual to date
Final
154
Recruitment outside Australia
Country [1] 23734 0
New Zealand
State/province [1] 23734 0
Canterbury

Funding & Sponsors
Funding source category [1] 308720 0
Charities/Societies/Foundations
Name [1] 308720 0
Canterbury Charity Hospital Trust
Country [1] 308720 0
New Zealand
Primary sponsor type
Individual
Name
Philip Bagshaw
Address
349-353 Harewood Road
Bishopdale
Christchurch 8054
Country
New Zealand
Secondary sponsor category [1] 309618 0
None
Name [1] 309618 0
None
Address [1] 309618 0
None
Country [1] 309618 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308643 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 308643 0
Ethics committee country [1] 308643 0
New Zealand
Date submitted for ethics approval [1] 308643 0
07/04/2021
Approval date [1] 308643 0
24/05/2021
Ethics approval number [1] 308643 0
21/NTB/101

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

Contacts
Principal investigator
Name 111406 0
A/Prof Philip Bagshaw
Address 111406 0
Canterbury Charity Hospital Trust
349-353 Harewood Road
Bishopdale
Christchurch 8054
Country 111406 0
New Zealand
Phone 111406 0
+6433602266
Fax 111406 0
+6433602616
Email 111406 0
[email protected]
Contact person for public queries
Name 111407 0
Philip Bagshaw
Address 111407 0
Canterbury Charity Hospital Trust
349-353 Harewood Road
Bishopdale
Christchurch 8054
Country 111407 0
New Zealand
Phone 111407 0
+6433602266
Fax 111407 0
+6433602616
Email 111407 0
[email protected]
Contact person for scientific queries
Name 111408 0
Philip Bagshaw
Address 111408 0
Canterbury Charity Hospital Trust
349-353 Harewood Road
Bishopdale
Christchurch 8054
Country 111408 0
New Zealand
Phone 111408 0
+6433602266
Fax 111408 0
+6433602616
Email 111408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified and combined individual participant data in the form of published results only.
When will data be available (start and end dates)?
Data are available at: Bagshaw P, Cameron C, Aramowicz J, Frampton C, Pretty C. Randomized controlled trial of effects of a familiarization video and patient-controlled Entonox inhalation on patient stress levels and clinical efficacy of flexible sigmoidoscopy without analgesia or sedation for investigation of fresh rectal bleeding. J Gastroenterol Hepatol. 2023 Dec 6. doi: 10.1111/jgh.16433.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
In order to repeat the statistical analyses in the published report.
How or where can data be obtained?
From the published journal or from the Principal Investigator on application to [email protected].


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.