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Completed

NCT Number: NCT07380035

Coercion in Same-Day Research Consent

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.

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Key information

Conditions

Consent of Patients Coercion to Participate in Research

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient scheduled to undergo ambulatory anterior cruciate ligament repair under general anesthesia with an adductor canal nerve block at Women's Colege Hospital
  • Age ≥18

Exclusion criteria

  • Inability to provide informed consent

Treatment and study plan

Invitation to Consent to Trial Participation

Other

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.

Primary outcomes

  1. Average score on combined modified coercion scales

    Time frame: Measured on postoperative day one.

    Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.

  2. Average Score on modified Iowa Coercion Questionnaire

    Time frame: Measured on postoperative day one.

    Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.

  3. Average Score on Modified Coercion Assessment Scale

    Time frame: Measured on postoperative day one.

    Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.

Secondary outcomes

  1. Rate of enrollment into the fictitious trial

    Time frame: 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.

  2. Responses to individual items on the combined modified coercion scales

    Time frame: Measured on postoperative day one.

    Each item has a minimum score of 1 and maximum score of 4, with higher scores corresponding to a greater degree of coercion.

Other outcomes

  1. Association between participant sex and average score on combined modified coercion scales

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant sex (categorical variable self-reported on the postoperative questionnaire) and average score on the 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).

  2. Association between participant sex and average score on the modified Iowa Coercion Questionnaire

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant sex (categorical variable self-reported on the postoperative questionnaire) and average score on the 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).

  3. Association between participant sex and average score on the modified Coercion Assessment Scale

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant sex (categorical variable self-reported on the postoperative questionnaire) and average score on the 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).

  4. Association between participant age and average score on combined modified coercion scales

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant age (continuous variable self-reported on the postoperative questionnaire) and average score on the 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).

  5. Association between participant age and average score on the modified Iowa Coercion Questionnaire

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant age (continuous variable self-reported on the postoperative questionnaire) and average score on the 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).

  6. Association between participant age and average score on the modified Coercion Assessment Scale

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant age (continuous variable self-reported on the postoperative questionnaire) and average score on the 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).

  7. Association between participant education and average score on combined modified coercion scales

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant total years of education (continuous variable self-reported on the postoperative questionnaire) and average score on the 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).

  8. Association between participant education and average score on the modified Iowa Coercion Questionnaire

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant total years of education (continuous variable self-reported on the postoperative questionnaire) and average score on the 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).

  9. Association between participant education and average score on the modified Coercion Assessment Scale

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant total years of education (continuous variable self-reported on the postoperative questionnaire) and average score on the 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).

  10. Association between participant country of upbringing and average score on combined modified coercion scales

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant country of upbringing (categorical variable self-reported on the postoperative questionnaire) and average score on the 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).

  11. Association between participant country of upbringing and average score on the modified Iowa Coercion Questionnaire

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant country of upbringing (categorical variable self-reported on the postoperative questionnaire) and average score on the 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).

  12. Association between participant country of upbringing and average score on the modified Coercion Assessment Scale

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant country of upbringing (categorical variable self-reported on the postoperative questionnaire) and average score on the 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).

  13. Association between participant minority status and average score on combined modified coercion scales

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant minority status (categorical variable self-reported on the postoperative questionnaire) and average score on the 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).

  14. Association between participant minority status and average score on the modified Iowa Coercion Questionnaire

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant minority status (categorical variable self-reported on the postoperative questionnaire) and average score on the 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).

  15. Association between participant minority status and average score on the modified Coercion Assessment Scale

    Time frame: Measured on postoperative day one.

    This secondary analysis uses linear regression to test for statistical dependence between participant minority status (categorical variable self-reported on the postoperative questionnaire) and average score on the 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).

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Toronto Metropolitan University
  • Women's College Hospital

Registry information

Official study title

Voluntariness of Same-Day Consent for Participation in Low-Risk Clinical Anesthesia Research Trials: A Prospective, Randomized Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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