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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if visual aids, such as posters and pamphlets, enhance caregivers' understanding and retention of anesthesia consent details for their children's surgeries. The study compares the standard method of providing consent information with a new approach that incorporates these visual aids. Caregivers of children undergoing elective surgeries, such as tonsillectomies or appendectomies, may be suitable participants for this trial. As an unphased trial, it offers caregivers the chance to contribute to improving communication methods in medical settings.

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 prior data suggests that these visual aids are safe for use in informed consent?

Research shows that pictures and diagrams during the consent process can be very helpful. Past studies have demonstrated that these visual aids improve caregivers' memory and understanding of important information about anesthesia for children. As a result, caregivers might feel more informed about the risks and benefits when their child undergoes surgery.

Regarding safety, visual aids differ from regular medical treatments, so they do not pose typical safety concerns. They serve as tools to make information clearer and easier to remember. Studies have not reported any negative effects from using visual aids. In fact, they often help reduce anxiety and increase satisfaction during the consent process. While the main goal is understanding, it is reassuring to know that these aids are safe and beneficial for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using visual aids in pediatric anesthesia consent because these aids can make complex medical information clearer and more understandable for both children and their guardians. Unlike standard consent processes that rely heavily on verbal explanations and written documents, visual aids can break down information into easily digestible parts using images and diagrams. This approach could lead to better-informed decision-making and reduce anxiety by ensuring everyone fully understands what to expect during anesthesia. By potentially enhancing comprehension, visual aids can improve the overall consent experience in medical settings.

What evidence suggests that using visual aids is effective for improving informed consent in pediatric anesthesia?

Research shows that pictures and diagrams can enhance understanding and memory during the informed consent process. In this trial, one group of participants will receive the standard anesthesia consent procedure with a visual aid. Studies have found that tools like pamphlets and posters help caregivers grasp important details about anesthesia and its risks. For example, one study found that visual aids improved parents' understanding and retention of information when their children underwent surgery for appendicitis. Additionally, using these visual aids does not significantly extend the consent process, making them both effective and efficient. Overall, these tools are crucial for ensuring caregivers know what to expect before their child's surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Niveditha Karuppiah

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05774743

NCT05774743 | Pediatric Anesthesia Consent - Visual Aids Various studies have demonstrated the use of visual aids by way of pamphlets, brochures and posters increased patient understanding of medication adherence and ...

2. withpower.com withpower.com/trial/phase-anaesthesia-therapy-2-2023-db15e

Visual Aids for Informed Consent in Pediatric Anesthesia 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6939572/

Evaluation of anesthesia informed consent in pediatric ... The aim of this study was to subjectively evaluate the understanding and recall of the informed consent by the parents.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30060912/

Use of standardized visual aids improves informed consent ... Visual aids improve understanding and retention of information given during the informed consent process of children with appendicitis.

5. researchgate.net researchgate.net/publication/51974941_Consent_for_pediatric_anesthesia_An_observational_study

Consent for pediatric anesthesia: An observational study This study aimed to observe and identify the number and nature of the anesthesia risks considered and communicated to parents/guardians and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10741887/

Pediatric Anesthesia Providers' Perspective on the Real ... Additionally, 50% of participants reported finding the Visual Patient Avatar useful for diverting children's attention during anesthesia ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6599866/

Audio‐visual presentation of information for informed consent ... The value of audio‐visual interventions as a tool for helping to enhance the informed consent process for people considering participating in clinical trials ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022346823002476

Effect of Multimedia Teaching Tools in Parental Anxiety ... The Multimedia tool aided consent procedure is effective in reducing parental anxiety and improving their comprehension and overall satisfaction.