NCT04613505

Determining Parental Attitudes Toward Day of Surgery Consent for Research

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 214 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Accepted

Summary

There are no studies examining parents' attitudes towards day of surgery consent for research. The purpose of the study is to determine the attitudes parents of potential research participants have toward being approached for day of surgery consent. The primary objective is to determine parental attitudes regarding day of surgery consent for anesthesia research. The secondary objective is to determine the boundaries for day of surgery consent (e.g., study types, interventions, risk factors).

Detailed description

This is a multi-phase prospective cohort study. In the first phase the investigators will interview parents and consult the Family Research Advisory Committee (FRAC) to determine their attitudes toward day of surgery research consent. The investigators will use the participants' responses and instruments already found in the literature to develop the questionnaire. In the second phase, the investigators will interview parents and consult FRAC about the questionnaire to determine which items to add, remove, or modify. In the third phase, the investigators will distribute the adapted questionnaire to clarify parents' attitudes surrounding day of surgery consent. The investigators will use the results of the third phase to develop a table of guidelines for day of surgery consent. In the final phase, the investigators will interview parents, healthcare professionals, and consult FRAC for feedback and modification of the table of guidelines.

Conditions

• Surgery
• Consent

Interventions

Type	Name	Description
BEHAVIORAL	Semi-structured interview	Participants will be asked a set of questions as applicable to each phase. Researchers will be able to ask additional questions as they arise within each interview.
BEHAVIORAL	Same day consent questionnaire	A questionnaire (yet to be developed) will be administered to participants.

Timeline

• Start date: 2020-01-22
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-11-03
• Last updated: 2025-02-10

Locations

1 site across 1 country: Canada