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Active, not recruiting Not applicable Interventional

Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol

ClinicalTrials.gov ID: NCT06705491

Public ClinicalTrials.gov record NCT06705491. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 5:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The Trauma-Informed Procedural Pain Intervention (TIPPI-R) has been developed as a standardized way to provide education and teach evidence-based strategies for managing pain and distress that may occur during pediatric cancer treatment. The purpose of this clinical trial study is to test how helpful TIPPI-R is in supporting children and families manage pain and distress during the initial stages of cancer treatment. The main questions this study aims to answer are: * Does TIPPI-R increase use of helpful pain coping strategies for pediatric cancer patients? * Does TIPPI-R help lower perceived pain intensity during initial stages of cancer treatment? * Does TIPPI-R increase patient and family confidence in coping with pain and distress during cancer treatment? Researchers will compare pain experiences and use of pain coping strategies for families who receive the TIPPI-R intervention and families who receive standard of care to see if TIPPI-R decrease pain and distress during the initial stages of cancer treatment. Participants will: * Complete surveys to measure pain and distress within 5 weeks of initial diagnosis (Time 1) * Either receive the TIPPI-R intervention or standard of care * Complete surveys to measure pain and distress 4 weeks after initial consent or TIPPI-R intervention delivery (Time 2)

Study identification

NCT ID
NCT06705491
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Louisville
Other
Enrollment
100 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
Up to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 6, 2025
Primary completion
Jun 29, 2026
Completion
Nov 30, 2026
Last update posted
Aug 24, 2026

2025 – 2026

United States locations

U.S. sites
4
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
UK DanceBlue Pediatric Hematology & Oncology Lexington Kentucky 40508
Kentucky Children's Hospital Lexington Kentucky 40536
Norton Children's Cancer Institute Louisville Kentucky 40202
Norton Children's Hospital Louisville Kentucky 40202

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06705491, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 24, 2026 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06705491 live on ClinicalTrials.gov.

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