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Completed
NCT05717465
Communicating Risks: Consent for Lumbar Puncture
Conditions: Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 52
Sponsor: University College London Hospitals
Location: United Kingdom
Summary
The goal of this randomized control trial is to compare the effect of visual aids on the recall of probabilistic risks in healthy participants.
The main questions it aims to answer are:Will participants consented using a consent process incorporating visual aids recall the consent process better?Will participants consented with a consent process incorporating visual aids have higher acceptability if a hypothetical, simulated complication were to occur?Is this method of consent (visual aids) usable, appropriate and acceptable?
Participants will be required to watch a brief video containing information on how a lumbar puncture is performed as well as the associated risks.Participants in the intervention group will receive information in the form of various visual aids (e.g.
anatomical diagrams, paling palettes and paling perspective scales).
The audio narration and information provided in both groups is identical.Participants will be tested on their knowledge of the procedureParticipants will be asked to rate their response to a series of procedure specific statements and statements from other validated scales.Researchers will compare the control and intervention group to see if there is improvement in the recall of information and which consent process is more acceptable, appropriate and usable.
Eligibility Criteria
Inclusion Criteria:Healthy individualsAbove 18 years oldNo underlying cognitive impairmentExclusion Criteria:Individuals with prior experience receiving, performing or observing a lumbar punctureLacks capacityHospitalized individuals
Source: ClinicalTrials.gov (NCT05717465). StuddyBuddy aggregates publicly available trial information.
