Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol (TIPPI-R)

January 28, 2026 updated by: Lauren Hayes, University of Louisville

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
      • Lexington, Kentucky, United States, 40508
        • Recruiting
        • UK DanceBlue Pediatric Hematology & Oncology
        • Contact:
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Children's Hospital
        • Contact:
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Children's Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIPPI-R
Behavioral: TIPPI-R
The TIPPI-R intervention protocol consists of a one session, during which time the interventionist offers psychoeducation related to the following content areas: procedural pain related to oncology treatment, factors that may affect the perception of pain, evidenced-based tools for assessing and monitoring pain, cognitive and behavioral pain management interventions, and resources to facilitate family to advocacy for pain management in a medical setting. During this session, the interventionist discusses opportunities for families to utilize skills throughout treatment, and addresses family questions as needed. A follow-up session 4 weeks after the initial intervention session will assess family knowledge and skills and offer a referral for a mental health provider, if further pain management support is needed. TIPPI-R is designed to be delivered by a psychologist, psychology trainee, or social worker working in the oncology context.
No Intervention: Standard of Care
Participants and families in this arm will receive the standard treatment for pain and distress during cancer treatment at each respective institution, which may include psychoeducation and support implementing pain coping skills from mental health providers within the healthcare system.
Experimental: Delayed Intervention Delivery
Participants will be moved into this arm if they are initially randomized into the intervention arm, but they receive the TIPPI-R intervention outside of the window dictated in the protocol. According to the protocol, consented participants should receive the interventions within 2 weeks of consent. If they do not, the TIPPI-R intervention will still be delivered and the participant will be moved to this arm of the study.
Behavioral: TIPPI-R
The TIPPI-R intervention protocol consists of a one session, during which time the interventionist offers psychoeducation related to the following content areas: procedural pain related to oncology treatment, factors that may affect the perception of pain, evidenced-based tools for assessing and monitoring pain, cognitive and behavioral pain management interventions, and resources to facilitate family to advocacy for pain management in a medical setting. During this session, the interventionist discusses opportunities for families to utilize skills throughout treatment, and addresses family questions as needed. A follow-up session 4 weeks after the initial intervention session will assess family knowledge and skills and offer a referral for a mental health provider, if further pain management support is needed. TIPPI-R is designed to be delivered by a psychologist, psychology trainee, or social worker working in the oncology context.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Coping Strategies
Time Frame: Pain coping strategies will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).
Families who receive TIPPI-R will report greater use of adaptive pain coping strategies than families in the standard of care condition. This is measured by Survey of Pain Management Practices, Pain Coping Questionnaire-Short Form (Parent and Child), and data abstraction from medical charts. The Survey of Pain Management Practices indicates how often pain management strategies are used over the past 7 days (or since diagnosis). Frequencies are rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Scores are calculated by summing the number of strategies used, with higher scores indicating greater frequency of use of adaptive coping strategies. The Pain Coping Questionnaire-Short Form (Child and Parent version) is a 16-item measure to assess how children cope with pain. Items are ranked on a 5-point Likert scale ranging from 1 (never) to 5 (very often). A mean scale score is calculated for each subscale, with higher scores indicating more of the measured construct.
Pain coping strategies will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Pain Intensity
Time Frame: Perceived pain intensity will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).
Patients and families who receive TIPPI-R will report lower perceived intensity of pain experienced by patient than patients and families in the standard of care condition. This outcome will be measured by the Child Pain Characteristics Survey. Children and parent proxy rate worst, least, and average pain over the last 7 days on a scale from 0 (no pain) to 10 (worst possible pain), identify the location(s) of the pain, and indicate what they believe to be the source(s) of the pain.
Perceived pain intensity will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).
Pain Catastrophizing
Time Frame: Pain catastrophizing will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).
Patients and families who receive TIPPI-R will report lower rates of pain catastrophizing than patients and families in the standard of care condition. This outcome will be measured by the Pain Catastrophizing Questionnaire-Parent and Child forms. These forms each include13 items across 3 subscales (rumination, magnification, and helplessness), which assess children's catastrophic thoughts and feelings about their pain. Raters indicate the extent to which they/their child experience each of the items using a 5-point Likert type scale ranging from not at all to extremely, with a higher score indicating more catastrophic thinking.
Pain catastrophizing will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).
Confidence Managing Pain and Distress
Time Frame: Confidence managing pain and distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).
Patients and families who receive TIPPI-R will report higher confidence facilitating patient coping with pain and distress than families in the treatment as usual condition. This outcome will be measured by the Confidence in Pain Management measure. The child/caregiver will rate three questions on a scale from 0 (not at all confident) to 10 (very confident). Higher numerical rating will indicate greater confidence in pain management.
Confidence managing pain and distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).
Distress
Time Frame: Distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).
Patients and families who receive TIPPI-R will report lower levels of distress than families in the treatment as usual condition. This outcome will be measured by the Emory Distress Thermometer. Caregiver and child (8 years and older) distress will be measured with 1 item, in which caregivers and patients will each indicate the degree of distress they have been experiencing in the past week ranging from 0 (no distress) to 10 (extreme distress).
Distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

University of Kentucky
Norton Healthcare
Kentucky Cabinet for Health and Family Services

Investigators

  • Principal Investigator: Lauren R Hayes, PhD, Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Actual)

November 26, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24.0284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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