CClinicalTrials.gg
RecruitingNCT07138482Updated Sep 10, 2026

Health Literacy in the Perioperative Setting

An observational study in Pediatric Surgery and Health Literacy, sponsored by Brittany Willer. Recruiting at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Brittany Willer · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
3 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pediatric Surgery
  • Health Literacy
03

In context

Lead sponsor

Brittany Willer is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • ASA ≥ 3
  • chronic pain condition
  • inpatient
  • regional anesthesia.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • OtherSurvey using a questionnaire.

    REDCap Survey

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: From enrollment to prior to surgery start.

Secondary outcomes

  1. 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.

    Time frame: From enrollment to prior to surgery start.

  2. 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.

    Time frame: Perioperative

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07138482
Lead sponsor
Brittany Willer
Responsible party
Brittany Willer (Pediatric Anesthesiologist, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Aug 22, 2025
Start date
Jun 4, 2025
Primary completion
Dec 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Catherine Roth, MPH
Contact
catherine.roth@nationwidechildrens.org
614-722-2997
Julie Rice-Weimer, RN
Contact
julie-rice-weimer@nationwidechildrens.org
614-370-4199

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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