NCT06705491 Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
| NCT ID | NCT06705491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Louisville |
| Condition | Procedural Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-02-07 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: * Patient is receiving treatment at Norton Children's Cancer Institute, Norton Children's Hospital, University of Kentucky Children's Hospital or DanceBlue Clinic. * Patient has been diagnosed with an oncology diagnosis. * Patient and family are English-speaking. * Patient is between the ages 0-18. Exclusion Criteria: * Families not proficient in English. * Patient is 19 years or older. * Patient is not receiving treatment at Norton Children's Cancer Institute, Norton Children's Hospital, University of Kentucky Children's Hospital or DanceBlue Clinic. * Patient does not have an oncology diagnosis. * Patient and family have any CPS involvement.
Contact & Investigator
Lauren R Hayes, PhD
PRINCIPAL INVESTIGATOR
Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine
Frequently Asked Questions
Who can join the NCT06705491 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Procedural Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06705491 currently recruiting?
Yes, NCT06705491 is actively recruiting participants. Contact the research team at lauren.hayes@louisville.edu for enrollment information.
Where is the NCT06705491 trial being conducted?
This trial is being conducted at Lexington, United States, Lexington, United States, Louisville, United States, Louisville, United States.
Who is sponsoring the NCT06705491 clinical trial?
NCT06705491 is sponsored by University of Louisville. The principal investigator is Lauren R Hayes, PhD at Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine. The trial plans to enroll 100 participants.