NCT07138482

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Jun 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jun 2025Jun 2028

Study Start

First participant enrolled

June 4, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

July 2, 2025

Last Update Submit

August 21, 2025

Conditions

Pediatric SurgeryHealth Literacy

Outcome Measures

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)

    From enrollment to prior to surgery start.

Secondary Outcomes (2)

  • 6-STAI

    From enrollment to prior to surgery start.

  • Postoperative patient pain scores

    Perioperative

Interventions

Survey using a questionnaire.OTHER

REDCap Survey

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Central Study Contacts

Catherine Roth, MPH

CONTACT

614-722-2997catherine.roth@nationwidechildrens.org

Julie Rice-Weimer, RN

CONTACT

614-370-4199julie-rice-weimer@nationwidechildrens.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Pediatric Anesthesiologist

Study Record Dates

First Submitted

July 2, 2025

First Posted

August 22, 2025

Study Start

June 4, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)