Health Literacy in the Perioperative Setting

Health Literacy and Social Determinants of Health (SDOH) in the Perioperative Setting

The purpose of this study is to determine the association of the social determinants of health with perioperative health literacy in caregivers of children presenting for surgery. Another purpose is to determine the association of caregiver health literacy with preoperative caregiver anxiety and postoperative patient pain scores.

Study Overview

• Status: Recruiting
• Conditions: Health Literacy; Pediatric Surgery
• Intervention / Treatment: Other: Survey using a questionnaire.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Catherine Roth, MPH; Phone Number: 614-722-2997; Email: Catherine.Roth@nationwidechildrens.org
• Study Contact Backup: Name: Julie Rice-Weimer, RN; Phone Number: 614-370-4199; Email: julie-rice-weimer@nationwidechildrens.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital
      • Contact: Catherine Roth, MPH; Phone Number: 614-722-2997; Email: Catherine.Roth@nationwidechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Caregivers of children age 3-17 presenting for surgery at NCH.

Description

Inclusion Criteria:

• Caregivers of children age 3-17 years
• Patient undergoing ambulatory dental rehabilitation, orchiopexy, inguinal hernia repair, or tonsillectomy +/- adenoidectomy +/- ear tubes under general anesthesia.
• Primary language must be English, Spanish, Arabic, Nepali, or Somali.

Exclusion Criteria:

• ASA ≥ 3
• chronic pain condition
• inpatient
• regional anesthesia.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sTOFHLA survey	Short Test of Functional Health Literacy in Adults Raw Score (0-36) Inadequate Functional Health Literacy (0-16) Marginal Functional Health Literacy (17-22) Adequate Functional Health Literacy (23-36)	From enrollment to prior to surgery start.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-STAI	6-item State Trait Anxiety Inventory survey 6 question survey on 1-4 Likert Scale (Not at all, Somewhat, Moderately, Very Much) with total scores ranging from 6-24. Higher scores indicate greater anxiety.	From enrollment to prior to surgery start.
Postoperative patient pain scores	Pain Scores using Numeric Rating Scale (NRS) on a scale of 0-10; Visual Analog Scale (VAS) on a scale of 0 "No Pain" to 10 "Worst Pain"; Wong-Baker FACES Pain Rating Scale; FLACC Scale for non-verbal or pre-verbal patients. Higher scores indicate higher levels of pain.	Perioperative

Collaborators and Investigators

• Sponsor: Brittany Willer

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 2, 2025
• First Submitted That Met QC Criteria: August 21, 2025
• First Posted (Actual): August 22, 2025

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No