SurgeryNCT04613505
Determining Parental Attitudes Toward Day of Surgery Consent for Research
An observational study of Surgery and Consent, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- What is being tested?
- Semi-structured interview and Same day consent questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 214 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All participants receiving same day surgery at our institution are eligible to participate.
Who may be able to join
- 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.
Who cannot join
- -Parents of children who are undergoing urgent or add-on procedures will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Being tested
- Semi-structured interview, Same day consent questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewBehavioural
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 questionnaireBehavioural
A questionnaire (yet to be developed) will be administered to participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental attitude towards day of surgery consent
Semi-structured interviews
Measured: Day of surgery
Secondary outcomes (2)
Boundary for day of surgery consent
Semi-structured interview
Measured: Day of surgery
Boundary for day of surgery consent
Questionnaires to be developed in phases 1 and 2 of the study
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start22 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Taylor, The Hospital for Sick Children
- Investigators
- Katherine Taylor, Principal investigator, Staff Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613505
- Sponsor's protocol ID
- 1000066221
- Status last verified
- Jan 2025
- First submitted
- 2 Oct 2020
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caldeira-Kulbakas M, Pehora C, Williams RJ, Soni L, Taylor KL. Determining Parental Attitudes Toward Day of Surgery Consent for Research. Paediatr Anaesth. 2026 May;36(5):560-566. doi: 10.1002/pan.70151. Epub 2026 Feb 26.
PubMed 41744088
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Parental Attitudes Toward Day of Surgery Consent for Research
- ClinicalTrials.gov ID
- NCT04613505
- Acronym / sponsor ID
- 1000066221
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Instrument Development | – | Behavioral: Semi-structured interviewParents 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. |
| Phase 2: Questionnaire Adaptation | – | Behavioral: Semi-structured interviewParents 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. |
| Phase 3: Questionnaire Application & Development of Day of surgery consent Table of Guidelines | – | Behavioral: Same day consent questionnaireParticipants will be asked to complete the questionnaire developed in Phase 2. |
| Phase 4: Table of Guidelines Refinement | – | Behavioral: Semi-structured interviewParticipants 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. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All participants receiving same day surgery at our institution are eligible to participate.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -Parents of children who are undergoing urgent or add-on procedures will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewParticipants 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. | Behavioural | Phase 1: Instrument Development, Phase 2: Questionnaire Adaptation, Phase 4: Table of Guidelines Refinement |
| Same day consent questionnaireA questionnaire (yet to be developed) will be administered to participants. | Behavioural | Phase 3: Questionnaire Application & Development of Day of surgery consent Table of Guidelines |
Primary outcome
Parental attitude towards day of surgery consent
Time frame: Day of surgery
Semi-structured interviews
2 secondary outcomes
Boundary for day of surgery consent
Time frame: Day of surgery
Boundary for day of surgery consent
Time frame: Day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 41744088Caldeira-Kulbakas M, Pehora C, Williams RJ, Soni L, Taylor KL. Determining Parental Attitudes Toward Day of Surgery Consent for Research. Paediatr Anaesth. 2026 May;36(5):560-566. doi: 10.1002/pan.70151. Epub 2026 Feb 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Taylor principal investigator
Staff Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Consent, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental attitude towards day of surgery consent (time frame: Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04613505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.