ClinConnect ClinConnect Logo
Search / Trial NCT06705491

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

Launched by UNIVERSITY OF LOUISVILLE · Nov 21, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new program called the Trauma-Informed Procedural Pain Intervention (TIPPI-R) designed to help children with cancer manage pain and distress during their treatment. The main goals are to see if TIPPI-R can help kids use better strategies to cope with pain, reduce how much pain they feel, and increase their confidence in handling the challenges of cancer treatment. Researchers will compare the experiences of families using TIPPI-R with those receiving standard care to find out if TIPPI-R makes a difference in managing pain and distress during the early stages of treatment.

To be eligible for this trial, children aged 0-18 must be receiving treatment at specific hospitals and have a confirmed cancer diagnosis. Families also need to be English-speaking. Participants will fill out surveys about their pain and feelings shortly after being diagnosed and again four weeks later, either after receiving the TIPPI-R intervention or standard care. This study is important as it aims to improve the support and coping strategies available to young cancer patients and their families during a challenging time.

Gender

ALL

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.

About University Of Louisville

The University of Louisville is a distinguished academic institution known for its commitment to advancing medical research and clinical innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise to conduct pioneering studies that aim to improve patient outcomes and enhance healthcare practices. With a focus on interdisciplinary collaboration and community engagement, the University of Louisville fosters an environment conducive to groundbreaking research across various medical fields, ensuring adherence to the highest ethical standards and regulatory compliance. Through its clinical trials, the university seeks to translate scientific discoveries into tangible benefits for patients and the broader community.

Locations

Louisville, Kentucky, United States

Lexington, Kentucky, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

Patients applied

0 patients applied

Trial Officials

Lauren R Hayes, PhD

Principal Investigator

Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported