Recruiting

Observational Study

Sponsor:

Brittany Willer

Code:

NCT07138482

Conditions

Pediatric Surgery

Health Literacy

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

Survey using a questionnaire.

Study Details

Brief 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.

Conditions

Pediatric Surgery

Health Literacy

Study ID

NCT07138482

Start date

Jun 4, 2025

Status verified date

Aug, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Survey using a questionnaire.

REDCap Survey

Primary outcome measure

  • sTOFHLA survey [ Time Frame: From enrollment to prior to surgery start. ]

Central Contacts and Locations

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

More Information

Sponsor

Brittany Willer

Last update posted

Aug 22, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brittany Willer on 2025-08-22.