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NCT Number: NCT07138482

Health Literacy 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.

Recruiting

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Key information

Conditions

Pediatric Surgery Health Literacy

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location status: Recruiting

Location contact

Catherine Roth, MPH

CONTACT

[email protected]

614-722-2997

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survey using a questionnaire.

Other

REDCap Survey

Primary outcomes

  1. sTOFHLA survey

    Time frame: From enrollment to prior to surgery start.

    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)

Secondary outcomes

  1. 6-STAI

    Time frame: From enrollment to prior to surgery start.

    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.

  2. Postoperative patient pain scores

    Time frame: Perioperative

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Roth, MPH

CONTACT

[email protected]

614-722-2997

Julie Rice-Weimer, RN

CONTACT

[email protected]

614-370-4199

Sponsors and collaborators

Lead sponsor

Brittany Willer

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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