Pediatric Anesthesia Consent - Visual Aids

NCT05774743 | Recruiting

• 1 other identifier: Pediatric Consent
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

pediatric anesthesia consent

Outcome Measures

Primary Outcomes (1)

• Difference in the overall recall score

  The primary outcome will be the difference in the overall recall score of risks associated with the surgery and anesthetic (described during the anesthesia consent process) between groups receiving the standard consent process and the standard consent with enhanced visual aid process. The recall score will be calculated using a weight of one unit for each of the fifteen "Common Risks and Events" correctly recalled following the consent process. A mean and standard deviation will be calculated for each group and compared using a two-tailed t-test. The scale to be used is the "Common Risks and Events Recall Scale" where each correctly recalled fact presented during the consent process is given a weight of one unit. A higher score indicates better caregiver recall.

  One year

Secondary Outcomes (2)

• Experience of the consent process using Likert scale analysis

  One year

• Impact of demographic factors on recall score

  One year

Study Arms (2)

Standard Consent

NO INTERVENTION

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

Consent with Visual Aid

EXPERIMENTAL

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

Other: Consent with Visual Aid

Interventions

Consent with Visual Aid 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.

Consent with Visual Aid

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Related Publications (4)

• Rosenfeld EH, Lopez ME, Yu YR, Justus CA, Borges MM, Mathai RC, Karediya A, Zhang W, Brandt ML. Use of standardized visual aids improves informed consent for appendectomy in children: A randomized control trial. Am J Surg. 2018 Oct;216(4):730-735. doi: 10.1016/j.amjsurg.2018.07.032. Epub 2018 Jul 24.

  PMID: 30060912 BACKGROUND

• Li FX, Nah SA, Low Y. Informed consent for emergency surgery--how much do parents truly remember? J Pediatr Surg. 2014 May;49(5):795-7. doi: 10.1016/j.jpedsurg.2014.02.075. Epub 2014 Feb 22.

  PMID: 24851773 BACKGROUND

• Lin YK, Yeh YS, Chen CW, Lee WC, Lin CJ, Kuo LC, Shi L. Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department: A Parallel-Group Randomized Controlled Trial. Healthcare (Basel). 2022 Nov 23;10(12):2353. doi: 10.3390/healthcare10122353.

  PMID: 36553877 BACKGROUND

• Bellolio MF, E Silva LOJ, Puls HA, Hargraves IG, Cabrera D. The research to practice continuum: Development of an evidence-based visual aid to improve informed consent for procedural sedation. J Clin Transl Sci. 2017 Oct;1(5):316-319. doi: 10.1017/cts.2017.303. Epub 2017 Dec 14.

  PMID: 29862058 BACKGROUND

MeSH Terms

Interventions

Consent Forms; Audiovisual Aids

Intervention Hierarchy (Ancestors)

Informed Consent; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations; Records; Organization and Administration; Health Services Administration; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Niveditha Karuppiah

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niveditha Karuppiah

CONTACT

519-685-8500; Niveditha.Karuppiah@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Assistant Professor

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 20, 2023
• Study Start: March 31, 2023
• Primary Completion: March 31, 2025
• Study Completion: May 1, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)