Visual Aids for Informed Consent in Pediatric Anesthesia

Overseen By Niveditha Karuppiah

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Disqualifiers: Major surgery, Emergency surgery, ASA IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

140 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Consent with Visual Aid, Visual Aid Consent, Informed Consent with Visual Aids in pediatric anesthesia?

Research shows that using visual aids during the informed consent process can improve understanding and satisfaction for parents and providers, as seen in studies involving appendectomy in children. This suggests that visual aids could also be beneficial in pediatric anesthesia by helping parents and children better understand the procedure and reduce anxiety. ^{1 2 3 4 5}

Is using visual aids for informed consent in pediatric anesthesia safe?

Research on visual aids for informed consent, like those used in surgeries such as appendectomies, shows they improve understanding and satisfaction without any reported safety issues. ^{1 3 4 5 6}

How does this treatment differ from other treatments for pediatric anesthesia informed consent?

This treatment is unique because it uses visual aids to improve understanding and reduce anxiety during the informed consent process for pediatric anesthesia, which is not commonly done with traditional written consent forms. ^{1 5 6 7 8}

What is the purpose of this trial?

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.

Research Team

Niveditha Karuppiah

Principal Investigator

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

Eligibility Criteria

This trial is for caregivers of children under 18 who are scheduled for elective surgeries like tonsil removal or hernia repair, requiring general anesthesia. It aims to help them understand the risks and process better.

Inclusion Criteria

I am a caregiver of a child under 18 needing surgery with anesthesia for common procedures.

Exclusion Criteria

I am a caregiver for someone who hasn't had major surgery or is critically ill according to ASA standards.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Consent Process

Caregivers undergo the anesthesia consent process with or without visual aids, followed by a survey to assess recall and satisfaction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recall and satisfaction of the consent process

1 year

Treatment Details

Interventions

• Consent with Visual Aid

Trial Overview The study tests if using visual aids (like posters or pamphlets) during the consent process before surgery can improve caregivers' recall and satisfaction compared to just getting verbal information.

Participant Groups

Group I: Consent with Visual Aid Experimental Treatment 1 Intervention

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

Group II: Standard Consent Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

Findings from Research

A review of 22 studies on informed consent in pediatric anesthesia revealed that parental understanding and preferences are the most frequently studied aspects, while the perspectives of pediatric patients themselves are often overlooked, comprising only 13% of the subjects.

The findings highlight the need for a more balanced approach that includes pediatric patients in the informed consent process, as their involvement is crucial for ethical decision-making in anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed Consent in Pediatric Anesthesia: A Narrative Review. Feinstein, MM., Pannunzio, AE., Lobell, S., et al.[2019]

A study involving 263 parents of children undergoing elective surgeries revealed that while most parents (96.2%) remembered receiving information about anesthesia administration, only 51.1% recalled details about the risks and 42.4% about side effects management, indicating significant gaps in information retention.

Parents had a generally poor recall of anesthesia-related information, scoring an average of only 4.9 out of 10, with better recall when information was provided by anesthesia providers compared to surgical personnel, suggesting the need for improved communication strategies in the informed consent process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental recall of anesthesia information: informing the practice of informed consent. Tait, AR., Voepel-Lewis, T., Gauger, V.[2021]

The use of a visual aid during the consent process for appendectomy significantly improved provider satisfaction and perceived parental understanding, with over half of the providers noting it made the process easier.

Importantly, the visual aid did not add significant time to the consent process, as 40% of providers felt it did not increase time, and 45% believed it only added a small amount of time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of provider satisfaction with the use of a standardized visual aid for informed consent for appendectomy in children. Johnson, BL., Rosenfeld, EH., Carter, BD., et al.[2020]

A study found that using a visual aid during the informed consent process significantly improved comprehension among parents of children undergoing surgery for appendicitis, with an odds ratio of 4.0, indicating a strong positive effect.

The visual aid was more effective than standard consent forms, regardless of parents' educational background, highlighting its potential to enhance understanding and retention of important medical information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of standardized visual aids improves informed consent for appendectomy in children: A randomized control trial. Rosenfeld, EH., Lopez, ME., Yu, YR., et al.[2019]

A pilot study with 30 participants showed that using a visual teaching aid during the informed consent process for colectomy significantly improved patients' recall of potential surgical complications and their understanding of the procedure.

The visual aid also helped reduce anxiety levels among patients, indicating that visual tools can enhance the informed consent experience, although satisfaction levels did not show a significant change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual teaching aids improve patient understanding and reduce anxiety prior to a colectomy. Stewart, JA., Wood, L., Wiener, J., et al.[2022]

In a study analyzing 91 pediatric pre-anesthesia consultations, it was found that 30% of consultations did not discuss any anesthesia risks, highlighting a significant gap in the informed consent process.

Trainee anesthetists discussed more specific risks (median of 3 risks) compared to consultant anesthetists (median of 1 risk), and patients with previous anesthesia experience had less detailed discussions about risks, indicating variability in communication practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consent for pediatric anesthesia: an observational study. Lagana, Z., Foster, A., Bibbo, A., et al.[2014]

In a study of 97 preanesthesia discussions at a pediatric hospital, most conversations included at least five key informed consent elements, with 100% including a description of the anesthesia plan, but only 18% soliciting a decision from parents.

Parents who recalled the description of the plan, risks, and benefits were more likely to remember these elements (75% recall) and had a higher understanding of them (97% understanding), highlighting the importance of including these elements in discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed consent in pediatric anesthesiology. Gentry, KR., Lepere, K., Opel, DJ.[2018]

Informed consent for clinical research in pediatric anesthesia requires both permission from a child's guardian and the child's own assent, ensuring that the process respects the child's understanding and abilities.

The article emphasizes the importance of tailoring the assent process to be age-appropriate and sensitive, making sure that children are adequately informed and involved in decisions about their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Permission and assent for clinical research in pediatric anesthesia. Erb, TO., Schulman, SR., Sugarman, J.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Informed Consent in Pediatric Anesthesia: A Narrative Review. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Parental recall of anesthesia information: informing the practice of informed consent. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

An assessment of provider satisfaction with the use of a standardized visual aid for informed consent for appendectomy in children. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Use of standardized visual aids improves informed consent for appendectomy in children: A randomized control trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Visual teaching aids improve patient understanding and reduce anxiety prior to a colectomy. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Consent for pediatric anesthesia: an observational study. [2014]

7. France pubmed.ncbi.nlm.nih.gov

Informed consent in pediatric anesthesiology. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Permission and assent for clinical research in pediatric anesthesia. [2019]