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NCT Number: NCT04613505

Determining Parental Attitudes Toward Day of Surgery Consent for Research

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).

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Key information

Conditions

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Semi-structured interview

Behavioral

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.

Same day consent questionnaire

Behavioral

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

Primary outcomes

  1. Parental attitude towards day of surgery consent

    Time frame: Day of surgery

    Semi-structured interviews

Secondary outcomes

  1. Boundary for day of surgery consent

    Time frame: Day of surgery

    Semi-structured interview

  2. Boundary for day of surgery consent

    Time frame: Day of surgery

    Questionnaires to be developed in phases 1 and 2 of the study

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2020
Registry last updated
Feb 10, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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