Determining Parental Attitudes Toward Day of Surgery Consent for Research

NCT04613505 | Completed

• 1 other identifier: 1000066221
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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).

Conditions

Surgery; Consent

Outcome Measures

Primary Outcomes (1)

• Parental attitude towards day of surgery consent

  Semi-structured interviews

  Day of surgery

Secondary Outcomes (2)

• Boundary for day of surgery consent

  Day of surgery

• Boundary for day of surgery consent

  Day of surgery

Study Arms (4)

Phase 1: Instrument Development

Parents will be asked to participate in a semi-structured interview with one of the researchers that will explore their attitudes toward day of surgery consent. Particular attention will be given to a) study designs, b) previous research experience, and c) previous medical experiences.

Behavioral: Semi-structured interview

Phase 2: Questionnaire Adaptation

Parents will be given approximately 5 minutes to review a questionnaire we developed using participant responses in Phase 1. After reviewing the questionnaire, participants will be asked to participate in a semi-structured interview with one of the investigators.

Behavioral: Semi-structured interview

Phase 3: Questionnaire Application & Development of Day of surgery consent Table of Guidelines

Participants will be asked to complete the questionnaire developed in Phase 2.

Behavioral: Same day consent questionnaire

Phase 4: Table of Guidelines Refinement

Participants will be given approximately 5 minutes to review the table of guidelines developed in Phase 3. After reviewing the guidelines, participants will be asked to participate in a semi-structured interview with one of the investigators.

Behavioral: Semi-structured interview

Interventions

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.

Phase 1: Instrument Development; Phase 2: Questionnaire Adaptation; Phase 4: Table of Guidelines Refinement

Same day consent questionnaire BEHAVIORAL

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

Phase 3: Questionnaire Application & Development of Day of surgery consent Table of Guidelines

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All participants receiving same day surgery at our institution are eligible to participate.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

• Katherine Taylor

  Staff Anesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: November 3, 2020
• Study Start: January 22, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)