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Video or verbal consent? A randomised trial of the informed consent process prior to endoscopy

Video or verbal consent? A randomised trial of the informed consent process prior to endoscopy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001185257
Enrollment
200
Registered
2018-07-17
Start date
2017-09-25
Completion date
2017-12-01
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to compare video assisted consent to standard verbal consent. We hypothesise that video assisted consent would help improve patient understanding and recall of the risks involved with their planned procedures, compared to standard verbal consent.

Interventions

Patients who came forward for either elective gastroscopy or colonoscopy were randomised to receive either standard verbal consent, or video assisted consent (intervention). Two videos were created, professionally filmed and narrated by a nurse investigator. The videos were 3.5 minutes long and designed to cover all aspects of legal informed consent. Subtitles were included to highlight individual risks as they were mentioned. The intervention was the demonstration of the video, played in the

Patients who came forward for either elective gastroscopy or colonoscopy were randomised to receive either standard verbal consent, or video assisted consent (intervention). Two videos were created, professionally filmed and narrated by a nurse investigator. The videos were 3.5 minutes long and designed to cover all aspects of legal informed consent. Subtitles were included to highlight individual risks as they were mentioned. The intervention was the demonstration of the video, played in the patient bed space and displayed on an A5-sized tablet with the use of earphones in order to minimise contamination bias with neighbouring patients. Patients who were scheduled for gastroscopy were shown the gastroscopy-specific video. Likewise for patients scheduled for colonoscopy. Patients who were scheduled to have both procedures were shown both videos. Following the video, patients had the opportunity for further discussion and to ask questions. Patients where then asked to sign a standard hospital consent form, and fill out the questionnaire.

Sponsors

Tauranga Hospital gastroenterology department
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

All consecutive patients aged 18 years or older scheduled for an outpatient gastroscopy, colonoscopy or both were considered for enrolment in the trial.

Exclusion criteria

Patients were excluded if they were having a procedure other than colonoscopy or gastroscopy such as Endoscopic Retrograde Cholangiopancreatography (ERCP) or a planned therapeutic intervention such as dilatation or variceal banding. Further exclusions included patients who would ordinarily require a third party to sign consent (due to age, intellectual disability, lack of capacity, those visually or hearing impaired) and patients with a language barrier such that an interpreter was required.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026