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Determining Parental Attitudes Toward Day of Surgery Consent for Research

Determining Parental Attitudes Toward Day of Surgery Consent for Research

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04613505
Enrollment
214
Registered
2020-11-03
Start date
2020-01-22
Completion date
2022-12-31
Last updated
2025-02-10

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

Conditions

Consent, Surgery

Brief 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.

Interventions

BEHAVIORALSemi-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.

BEHAVIORALSame day consent questionnaire

A questionnaire (yet to be developed) will be administered to participants.

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* The parents of children undergoing elective surgical procedures at Sickkids will be invited to participate in the study. * If multiple parents are present, they are permitted to participate jointly; however, their participation will count as a single response.

Exclusion criteria

-Parents of children who are undergoing urgent or add-on procedures will be excluded.

Design outcomes

Primary

MeasureTime frameDescription
Parental attitude towards day of surgery consentDay of surgerySemi-structured interviews

Secondary

MeasureTime frameDescription
Boundary for day of surgery consentDay of surgerySemi-structured interview

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026