Pediatric SurgeryNCT07138482
Health Literacy in the Perioperative Setting
An observational study of Pediatric Surgery and Health Literacy, run by Brittany Willer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Pediatric Surgery, Health Literacy
- What is being tested?
- Survey using a questionnaire.
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Caregivers of children age 3-17 presenting for surgery at NCH.
Who may be able to join
- 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.
Who cannot join
- ASA ≥ 3
- chronic pain condition
- inpatient
- regional anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Catherine Roth, MPH, 614-722-2997, catherine.roth@nationwidechildrens.org
About this study
Official title: 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.
- Conditions
- Pediatric Surgery, Health Literacy
- Being tested
- Survey using a questionnaire.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
REDCap Survey
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to prior to surgery start.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start4 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brittany Willer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brittany Willer, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138482
- Sponsor's protocol ID
- STUDY00004902
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy and Social Determinants of Health (SDOH) in the Perioperative Setting
- ClinicalTrials.gov ID
- NCT07138482
- Acronym / sponsor ID
- STUDY00004902
- Conditions
- Pediatric Surgery, Health Literacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Brittany WillerUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Caregivers of children age 3-17 presenting for surgery at NCH.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- ASA ≥ 3
- chronic pain condition
- inpatient
- regional anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey using a questionnaire.REDCap Survey | Other | – |
Primary outcome
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)
2 secondary outcomes
6-STAI
Time frame: From enrollment to prior to surgery start.
Postoperative patient pain scores
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Surgery and Health Literacy, run by Brittany Willer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Roth, MPH (614-722-2997, catherine.roth@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sTOFHLA survey (time frame: From enrollment to prior to surgery start.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.