Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID06705491

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

Led by University of Louisville · Updated on 2026-01-30

100

Participants Needed

4

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of Louisville

Lead Sponsor

K

Kentucky Cabinet for Health and Family Services

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Trauma-Informed Procedural Pain Intervention (TIPPI-R) to support children and families in managing pain and distress during the initial stages of cancer treatment. This trial aims to see if TIPPI-R increases the use of helpful pain coping strategies, lowers perceived pain intensity, and boosts confidence in coping with pain and distress for pediatric cancer patients. Families receiving TIPPI-R will be compared to those receiving standard care to measure these effects. Participants will either receive TIPPI-R, a one-session intervention delivered by a psychologist, psychology trainee, or social worker, which provides education on procedural pain, pain perception factors, pain assessment tools, and cognitive-behavioral pain management strategies, or they will receive standard care which may include psychoeducation and support from mental health providers. If the intervention is delivered later than planned, participants will be moved to a delayed intervention group. A follow-up session is conducted 4 weeks after the initial TIPPI-R session to assess knowledge, skills, and offer further referrals if needed. During the study, participants complete surveys measuring pain coping strategies, perceived pain intensity, pain catastrophizing, confidence managing pain and distress, and distress at baseline (within 5 weeks of diagnosis) and again 4 to 6 weeks later. The study uses randomization without masking and collects data to understand how TIPPI-R impacts pain and distress during early cancer treatment. Participants may be involved for about 4 to 6 weeks, including the initial intervention and follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Approximately 4 weeks

Participants receive a one-session psychoeducation intervention about procedural pain and pain management strategies, followed by a single follow-up session approximately 4 weeks later to assess knowledge and offer further support.

1 initial session and 1 follow-up session (in-person or virtual)

Trial Site Locations

Total: 4 locations

1

UK DanceBlue Pediatric Hematology & Oncology

Lexington, Kentucky, United States, 40508

Actively Recruiting

2

Kentucky Children's Hospital

Lexington, Kentucky, United States, 40536

Actively Recruiting

3

Norton Children's Cancer Institute

Louisville, Kentucky, United States, 40202

Actively Recruiting

4

Norton Children's Hospital

Louisville, Kentucky, United States, 40202

Actively Recruiting

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Research Team

L

Lauren R Hayes, PhD

M

Meghan Marsac, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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Frequently Asked Questions

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https://pubmed.ncbi.nlm.nih.gov/33369896

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Julia Price, Nancy Kassam-Adams, Melissa A Alderfer...

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Abby R Rosenberg, Miranda C Bradford, Courtney C Junkins...

https://pubmed.ncbi.nlm.nih.gov/31532518

Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis.

Meredith Lutz Stehl, Anne E Kazak, Melissa A Alderfer...

https://pubmed.ncbi.nlm.nih.gov/19091806