|

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

RECRUITINGN/ASponsored by University of Louisville
Actively Recruiting
PhaseN/A
SponsorUniversity of Louisville
Started2025-02-07
Est. completion2026-06
Eligibility
Healthy vol.Accepted
Locations4 sites

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

Healthy volunteers accepted
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.

Conditions3

CancerCancer-related PainProcedural Pain

Locations4 sites

UK DanceBlue Pediatric Hematology & Oncology
Lexington, Kentucky, 40508
Meghan Marsac, PhDmeghan.marsac@uky.edu
Kentucky Children's Hospital
Lexington, Kentucky, 40536
Meghan Marsac, PhDmeghan.marsac@uky.edu
Norton Children's Cancer Institute
Louisville, Kentucky, 40202
Lauren R Hayes, PhD502-588-0800lauren.hayes@louisville.edu
Norton Children's Hospital
Louisville, Kentucky, 40202
Lauren R Hayes, PhD502-588-0800lauren.hayes@louisville.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.