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

Last updated: January 28, 2026
Sponsor: University of Louisville
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer Pain

Pain

Chronic Pain

Treatment

TIPPI-R

Clinical Study ID

NCT06705491
24.0284
  • Ages < 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patient is receiving treatment at Norton Children's Cancer Institute, NortonChildren'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

Exclusion Criteria:

  • Families not proficient in English.

  • Patient is 19 years or older.

  • Patient is not receiving treatment at Norton Children's Cancer Institute, NortonChildren'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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: TIPPI-R
Phase:
Study Start date:
February 07, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Kentucky Children's Hospital

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • UK DanceBlue Pediatric Hematology & Oncology

    Lexington, Kentucky 40508
    United States

    Site Not Available

  • Norton Children's Cancer Institute

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Children's Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Kentucky Children's Hospital

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Active - Recruiting

  • UK DanceBlue Pediatric Hematology & Oncology

    Lexington 4297983, Kentucky 6254925 40508
    United States

    Active - Recruiting

  • Norton Children's Cancer Institute

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

  • Norton Children's Hospital

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

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