Trauma-Informed Intervention for Procedural Pain

(TIPPI-R Trial)

Not yet recruiting at 3 trial locations

Overseen By Lauren R Hayes, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Non-English, Age 19+, CPS involvement

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called TIPPI-R, designed to help children with cancer and their families manage pain and distress during early treatment stages. The researchers aim to determine if TIPPI-R can increase the use of effective pain-coping strategies, reduce pain perception, and boost confidence in handling pain and stress. Participants will either receive this new program or continue with standard care and share their experiences through surveys. English-speaking families of children diagnosed with cancer and receiving treatment at specific hospitals may be a good fit for this study. As an unphased trial, this study offers families the opportunity to contribute to innovative approaches in managing cancer-related pain and distress.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on managing pain and distress during cancer treatment, so it's best to discuss your medications with the trial team.

What prior data suggests that the TIPPI-R intervention is safe for managing pain and distress in pediatric cancer patients?

Research has shown that the Trauma-Informed Procedural Pain Intervention (TIPPI-R) is generally easy for families to use. Studies have found that families using TIPPI-R experience less anxiety about treatment. This suggests the program might help children and families feel calmer during medical procedures.

No specific reports of negative effects from TIPPI-R exist. As it focuses on teaching pain management strategies rather than using medication, the risk of side effects is low. Overall, TIPPI-R appears to be a safe way to help manage pain and stress in children receiving cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TIPPI-R intervention because it offers a trauma-informed approach to managing procedural pain during cancer treatments, which is not typically the focus of standard care. Unlike conventional methods that may primarily involve medication and basic psychoeducation, TIPPI-R emphasizes understanding and addressing the psychological impact of trauma on pain perception. This method aims to improve pain coping skills through a more empathetic and personalized approach, potentially leading to better pain management and emotional well-being for patients and their families.

What evidence suggests that TIPPI-R is effective for managing pain and distress during pediatric cancer treatment?

Research has shown that the Trauma-Informed Procedural Pain Intervention (TIPPI-R), which participants in this trial may receive, is designed to help children and families manage pain and stress during cancer treatment. One component of TIPPI-R is hypnosis, which other studies have found to reduce pain. Earlier versions of this program, such as TIPPI-F, reduced anxiety in families undergoing treatment but did not significantly change pain levels. TIPPI-R focuses on teaching families coping strategies for pain, potentially boosting their confidence in managing pain and stress. While promising evidence supports its components, specific data on pain reduction for TIPPI-R is still being collected. ^{1 2 3 4 6}

Who Is on the Research Team?

Lauren R Hayes, PhD

Principal Investigator

Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine

Are You a Good Fit for This Trial?

This trial is for children with cancer experiencing pain during treatment. Participants must be within the first 5 weeks of their initial diagnosis and able to complete surveys. There's no mention of specific exclusion criteria, so it seems open to those meeting the inclusion terms.

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

I have been diagnosed with cancer.

Exclusion Criteria

Patient is not receiving treatment at Norton Children's Cancer Institute, Norton Children's Hospital, University of Kentucky Children's Hospital or DanceBlue Clinic

Families not proficient in English

Patient and family have any CPS involvement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants complete surveys to measure pain and distress within 5 weeks of initial diagnosis

5 weeks

1 visit (in-person)

Intervention

Participants receive either the TIPPI-R intervention or standard of care

2 weeks

Follow-up

Participants complete surveys to measure pain and distress 4 weeks after initial consent or TIPPI-R intervention delivery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TIPPI-R

Trial Overview The study tests TIPPI-R, a program designed to educate and teach strategies for managing pain and distress in pediatric cancer patients. It compares the effectiveness of TIPPI-R against standard care by measuring coping strategy use and perceived pain intensity.

How Is the Trial Designed?

Group I: TIPPI-R Experimental Treatment 1 Intervention

Group II: Delayed Intervention Delivery Experimental Treatment 1 Intervention

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.

Group III: Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Kentucky Cabinet for Health and Family Services

Collaborator

Trials

1

Recruited

100+

Norton Healthcare

Collaborator

Trials

17

Recruited

2,900+

Published Research Related to This Trial

Trauma-informed care (TIC) is recognized as the clinical standard for treating patients who have experienced sexual trauma, emphasizing the importance of understanding the impact of trauma on individuals.

TIC is built on five core principles: safety, choice, collaboration, trustworthiness, and empowerment, which guide healthcare providers in delivering sensitive and effective care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Can a Trauma-Informed Care Approach Be Applied to Patients With Gynecologic Cancer? Wilson, CM., Parrish, H.[2023]

A one-day training program for substance use disorder professionals significantly increased the rate of inquiries about physical abuse by 18% in the six months following the training, indicating its effectiveness in enhancing trauma inquiry practices.

However, the training did not improve inquiries about sexual abuse, emotional abuse, or neglect, suggesting that a longer training duration or additional support may be necessary to address these areas effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning How to Ask - Does a one-day training increase trauma inquiry in routine substance use disorder practice? Results of a cluster-randomized controlled trial. Lotzin, A., Buth, S., Sehner, S., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06705491?cond=Oncology&locStr=United+States&country=United+States&aggFilters=status:%2Cages:

Trauma-Informed Procedural Pain Intervention: Refinement ... 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 ...

2. scholars.uky.edu scholars.uky.edu/en/projects/trauma-informed-procedural-pain-intervention-refining-a-piloted-i-2/

Trauma-Informed Procedural Pain Intervention: Refining a ... The Trauma-Informed Procedural Pain Intervention (TIPPI) is designed as an evidence-based treatment protocol to facilitate enhanced pain management strategies.

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/21694826251341311?int.sj-full-text.similar-articles.2

Trauma-Informed Pediatric Pain Intervention Results: Families who completed TIPPI-F reported decreased treatment anxiety, but no change in distress or pain and hurt. Feedback highlighted TIPPI-F strengths ...

4. withpower.com withpower.com/trial/trauma-informed-intervention-for-procedural-pain-66efe

Trauma-Informed Intervention for Procedural Pain (TIPPI-R ... What data supports the effectiveness of the treatment TIPPI-R for procedural pain? Research shows that hypnosis, a component of TIPPI-R, can reduce pain ...

5. researchgate.net researchgate.net/publication/391870601_Trauma-Informed_Procedural_Pain_Intervention_Development_and_Refinement_of_an_Intervention_for_Pediatric_Cancer

Trauma-Informed Procedural Pain Intervention Results: Families who completed TIPPI-F reported decreased treatment anxiety, but no change in distress or pain and hurt.

6. clin.larvol.com clin.larvol.com/trial-detail/NCT06705491

Trauma-Informed Procedural Pain Intervention 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 ...