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NCT06705491 | NOT YET RECRUITING | Procedural Pain

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

University of Louisville

Information provided by (Responsible Party):

Lauren Hayes

Brief 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)

Condition or disease

Procedural Pain

Cancer-related Pain

Intervention/treatment

TIPPI-R

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol

Location Details

NCT06705491

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Kentucky

UK DanceBlue Pediatric Hematology & Oncology

Lexington, Kentucky, United States, 40508

Not yet recruiting

United States, Kentucky

Kentucky Children's Hospital

Lexington, Kentucky, United States, 40536

Not yet recruiting

United States, Kentucky

Norton Children's Cancer Institute

Louisville, Kentucky, United States, 40202

Not yet recruiting

United States, Kentucky

Norton Children's Hospital

Louisville, Kentucky, United States, 40202