Pediatric Anesthesia Consent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2025-05-01

Brief Summary

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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.

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Detailed Description

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The process of consent is unique and challenging in pediatrics as the patients themselves are not able to give their own consent. Instead the consent is given by their caregiver (parent/guardian). The elements of a good consent include - disclosure, comprehension, and voluntary choice.1 To achieve this the physician obtaining consent must clearly communicate and provide the caregivers with the description of the procedures and risks. For the consent process to be successful, it requires the caregiver to understand the information provided to them. The posters will provide the same information on the conduct of a general anesthetic and risks that the anesthesiologist will discuss with the caregivers prior to surgery. The posters will contain pictures and keywords describing the same information. The post consent questionnaire will assess the recall and satisfaction of the caregivers to the consent process.

Various studies have demonstrated the use of visual aids by way of pamphlets, brochures and posters increased patient understanding of medication adherence and the details of surgical procedures.2-5 However, there is no recent data on the use of these aids in the anesthesia consent process, especially in the pediatric population. The investigators aim to develop a visual aid describing the risks of anesthesia to supplement the pediatric consent process. The investigators hope to improve the consent process for pediatric patients and their caregivers and increase caregiver understanding and recall of the risks of general anesthesia. The investigators will include pediatric patients who are undergoing elective surgery under general anesthesia and their caregivers.

Caregivers of pediatric patients who are undergoing elective surgical procedures that require general anesthesia will be recruited to the study and randomized into one of two groups: 1) Group 1 participants will complete the anesthesia consent process as per standard protocol without the use of visual aids. This anesthesia consent process will verbally discuss and explain the type of anesthesia being used, airway management strategies, pain management, and associated risks. The caregivers will then be asked verbally or through writing to answer survey questions which includes caregiver age, sex, education level, occupation, relationship to the patient, and recall of consent process (type of anesthesia, risks involved, etc.). The survey will be administered in the recovery unit after the surgery before discharge from the recovery unit.

Group 2 participants will complete the anesthesia consent process as per standard protocol with the additional use of visual aids (poster that has been attached in Section 2.22). The visual aid will contain a brief note on general anesthesia for elective pediatric surgery and its safety. It will also contain a pictorial representation of the common events and risks involved in receiving a general anesthetic. This anesthesia consent process will verbally and pictorially discuss and explain the type of anesthesia being used, airway management strategies, pain management, and associated risks. The caregivers will then be asked verbally or through writing to answer survey questions which includes caregiver age, sex, education level, occupation, relationship to the patient, and recall of consent process (type of anesthesia, risks involved, etc.). The survey will be administered while the caregivers are in the waiting room during surgery or in the recovery unit after the surgery before discharge from the recovery unit and is expected to take less than 5 minutes to complete. Completion of this survey will end the participants' involvement in this study.

The caregivers will be consented to participate in the study after the anesthesia consent process (but before administration of the caregiver survey) to avoid the risk of recall bias. They will not be made aware of the different methods of consent being administered at the time of anesthesia consent. If the caregiver does not provide consent to participate in this study then the caregiver questionnaire will not be administered and data will not be collected for the purpose of this study. The addition of the visual aids will only enhance the consent process and have the potential for this group of caregiver participants to gain additional information about the anesthesia consent process compared to the standard consent protocol. Thus, since being randomized to the group that would receive the visual aids would not produce any detriment as compared to the standard consent protocol, the study team believes delaying obtaining informed consent to participate in this study until after the anesthesia consent process has been completed is reasonable for this study design.

All statistical analysis will be completed through R Studio version 3.6.0. Descriptive statistics will be reported for baseline characteristic using proportions for categorical variables and means and standard deviations for continuous variables.

If the recall score follows a normal distribution, a two-tailed Student's t-test will be performed to examine the difference in mean recall score between groups otherwise a non-parametric Mann-Whitney U test will be performed. A multivariable linear regression analysis will be performed to estimate correlation coefficients and 95% confidence intervals between baseline characteristics and recall score as a secondary explorative analysis.

Conditions

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Anesthesia Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard Consent

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Consent with Visual Aid

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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

Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No