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?
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.
Philip Bagshaw
150 participants
Sep 22, 2021
Interventional
Conditions
Summary
The purpose of this study is to find out how to make examination of the lower bowel by a flexible telescope called flexible sigmoidoscopy (F/S) more pleasant for patients and better by allowing more bowel to be seen and treated. This will be done by seeing how helpful it is for patients to view a video before hand about what happens with F/S if they so wish, and to breathe an analgesic and sedative gas mixture call Entonox (laughing gas) during F/S if they so wish. Those taking part in the study will be asked to fill in questionnaires before and after the F/S and to wear an ECG monitor during it. Those in the study will be placed by chance in one of three possible groups. One group will have standard care; a second group will also see a video; a third group will see the video and be able to breathe the Entonox gas. Whether or not they take part will be by their free choice. If they don’t want to take part they don’t have to give a reason, and it won’t affect the care they receive. The idea of the study is to find out if viewing a video and breathing a pain-relieving gas mixture will make a telescope examination of the lower bowel produce less discomfort, pain and anxiety, and be more effective.
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria17
- Unwilling or unable to give informed consent.
- Significant medical co-morbidities (ASA 3 & 4).
- Acute asthma or advanced COPD (O2 Stats < 94%)
- History of pneumothorax.
- Decompression sickness or recent dive.
- Pulmonary hypertension.
- Severe bone marrow depression or similar haematological disorders
- e.g. homocysteinaemia.
- During first trimester of pregnancy.
- Middle ear disease or surgery.
- Obstruction of sinus cavities
- Recent eye surgery or gas injections.
- Gross abdominal distension.
- Any anticoagulant and anti-platelet medication or known bleeding diathesis.
- Strong sedative or analgesic medication e.g. Benzodiazepines, opioids.
- Vitamin B12 deficiency
- Severe terminal disease or life expectance of less than 5 years.
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Interventions
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.
Locations(1)
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ACTRN12621000918820