NCT07380035|Completed
Coercion in Same-Day Research Consent
Voluntariness of Same-Day Consent for Participation in Low-Risk Clinical Anesthesia Research Trials: A Prospective, Randomized Trial
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Voluntariness of Same-Day Consent for Participation in Low-Risk Clinical Anesthesia Research Trials: A Prospective, Randomized Trial
Sponsor study identifier
Secondary identifiers
OTHER · Open Science Framework
interventional
114
1 country
1
Study Start
June 4, 2024
Actual (reported)Primary Completion
June 3, 2025
Actual (reported)Study Completion
June 6, 2025
Actual (reported)As a result of their unique practice patterns, many specialist physicians typically only meet patients on the date of an intervention such as surgery. However, some of the world's most prestigious academic centers do not allow research participants to be recruited on the same day as surgery. This is because of concerns, shared by researchers and research ethics boards, that patients may be too anxious or rushed to provide informed, voluntary consent immediately before an operation. This is not supported by evidence, and leads to potential inequities by restricting patients' opportunities to contribute to and benefit from research. The investigators undertook a randomized controlled trial incorporating deception to study the voluntariness of research consent provided by patients invited to enroll in a fabricated anesthesia research study at Women's College Hospital in Toronto, Ontario, Canada. Patients undergoing day surgery were randomized to receive research recruitment opportunities either days before surgery in the pre-operative assessment clinic, or on the surgical date. Post-operatively, patient's perceptions of undue influence or coercion in the consent process were examined with questionnaires and compared between these groups. This trial will help to design future perioperative studies, and will answer the important question of whether truly voluntary and informed same-day consent can be provided for participation in perioperative research.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 6, 2025
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 4, 2024
Actual (reported)June 3, 2025
Actual (reported)June 6, 2025
Actual (reported)January 16, 2026
Actual (reported)February 2, 2026
Actual (reported)Average score on combined modified coercion scales
Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.
Measured on postoperative day one.
Average Score on modified Iowa Coercion Questionnaire
Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.
Measured on postoperative day one.
Average Score on Modified Coercion Assessment Scale
Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.
Measured on postoperative day one.
Rate of enrollment into the fictitious trial
Measured when patients were approached with an invitation to participate in the trial. For patients in the Advance Consent Group this was, on average, preoperative day seven. For patients in the Day of Surgery Group this was postoperative day zero.
Responses to individual items on the combined modified coercion scales
Measured on postoperative day one.
Association between participant sex and average score on combined modified coercion scales
Measured on postoperative day one.
Association between participant sex and average score on the modified Iowa Coercion Questionnaire
Measured on postoperative day one.
Association between participant sex and average score on the modified Coercion Assessment Scale
Measured on postoperative day one.
Patients in this group were presented with the opportunity for trial participation in advance of surgery, during preoperative assessment approximately one week prior in the Pre-Anesthesia Clinic. Recruitment took place via telephone during this pre-operative assessment, and followed all standard procedures for trial recruitment at Women's College Hospital.
Patients in this group were presented with the opportunity for trial participation on the day of surgery, immediately before proceeding to their operation at Women's College Hospital. Recruitment took place in person at the bedside, and otherwise followed all standard procedures for trial recruitment at Women's College Hospital.
In this trial, the intervention being studied was the timing of an invitation to participate in a fabricated low-risk clinical anesthesia research trial. Patients were recruited into this fictitious trial either several days in advance of surgery, or on the day of surgery, and post-operative evaluations aimed to measure whether these groups experienced different degrees of coercion or voluntariness in their decisions to participate.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Women's College Hospital
Toronto, Ontario, M5S 1B2, Canada
Brenna CTA, Walton N, Cohn M, Siddiqui U, Huszti E, Brull R. Coerced consent in clinical research: study protocol for a randomized controlled trial. Trials. 2024 Jul 4;25(1):452. doi: 10.1186/s13063-024-08294-4.
Richard Brull, MD, FRCPC
University of Toronto
114 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2026
First Posted
February 2, 2026
Study Start
June 4, 2024
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 3, 2025
Actual (reported)Study Completion
June 6, 2025
Actual (reported)Last Updated
February 2, 2026
Record last verified: 2026-01
Deidentified, aggregate trial data supporting the findings of this study will be made available upon reasonable request to the corresponding author after publication.
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Source: ClinicalTrials.gov.
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