The impact of endoscopy sedation information sheets on the level of concern regarding possible awareness in patients undergoing endoscopy sedation

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001310853

Enrollment

187

Registered

2021-09-27

Start date

2017-01-01

Completion date

2017-12-31

Last updated

2021-10-04

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

Conditions

None listed

Brief summary

This study investigates the role of endoscopy sedation information sheets in reducing the level of concern regarding possible awareness during the procedure. We hypothesised that concern of awareness would be reduced with the introduction of the information sheet in the intervention group compared with control group receiving only the standard procedure consent form.

Interventions

Participants in the intervention group will be sent in the mail the Australian Society of Anaesthetists “Anaesthesia for Endoscopy” information sheet at least one week prior to their scheduled endoscopy. This is a one page document of estimated reading time 5 minutes. On the day of the procedure the intervention group also received the Queensland Health "Anaesthetic Consent Information". Adherence to the intervention was checked on the day of anaesthesia via a verbal question of whether the pati

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- adequate English comprehension with no language barrier, cognitive deficit or intellectual barrier - adequate English reading level equivalent to a grade 8 student or above - no significant cardiovascular or respiratory impairment (ASA IV and V) - outpatient endoscopies.

Exclusion criteria

- emergency and inpatient endoscopies.

Outcome results