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

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

Recruiting
18 years and younger
All
Phase N/A

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Overview

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

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.

Study details
    Procedural Pain
    Cancer-related Pain

NCT06705491

University of Louisville

31 January 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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