Recruiting

Observational Study

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT05774743

Conditions

Anesthesia

Surgery

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

Consent with Visual Aid

Study Details

Brief summary:

Informed consent in pediatric anesthesia is obtained from the caregiver by the anesthesiologist prior to surgery. Studies demonstrate that caregivers often do not fully understand or recall the information (risks and benefits) discussed with them during the consent process. The use of visual aids (pictographs etc.) in the consent process has been studied and found beneficial in increasing recall of the discussion about surgery (appendectomy) and for sedation in the emergency department. The investigators developed posters/pamphlets as visual aids with information about general anesthesia and risks involved to help the caregivers understand the process and risks better when their child comes in for an elective procedure. This randomized controlled trial comparing the recall and satisfaction of the standard consent process with and without the use of the visual aids will help evaluate whether the consent process and caregiver understanding can be improved by using these aids.

Conditions

Anesthesia

Surgery

Study ID

NCT05774743

Start date

Mar 31, 2023

Status verified date

Feb, 2024

Completion date

May 1, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • caregivers of pediatric patients under the age of 18 years old who are undergoing elective surgical procedures (adenoidectomy, tonsillectomy, tympanoplasty, mastoidectomy, strabismus repair, appendectomy, cholecystectomy, herniotomy, circumcision, etc.) requiring a general anesthetic

Exclusion Criteria:Caregivers (study participants) will be excluded from the study if the patient they are a caregiver for meets any of the following criteria:

  • having major surgery
  • emergency surgery
  • ASA (American Society of Anesthesiology) IV and above
  • has had previous surgery
  • pediatric patients who sign their own consent

Caregivers (study participants) will be excluded if:

  • language of communication other than English
  • they refuse to provide informed consent

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Standard Consent

Participants will receive the standard anesthesia consent procedure without the use of the visual aid that is being used in this study.

experimental: Consent with Visual Aid

Participants will receive standard anesthesia consent procedure with the use of the visual aid that is being used in this study.

Interventions

Consent with Visual Aid

Participants who receive the study intervention will receive the standard anesthesia consent procedure with the addition of the visual aid. The visual aid is a poster with pictorial representations of the information that is verbally communicated to participants during the standard consent process.

Primary outcome measure

  • Difference in the overall recall score [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Feb 26, 2024

Last verified

Feb, 2024

Keywords

  • pediatric anesthesia consent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-02-26.