Trauma-Informed Intervention for Procedural Pain

(TIPPI-R Trial)

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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment TIPPI-R for procedural pain?

Research shows that hypnosis, a component of TIPPI-R, can reduce pain during medical procedures. Studies found that hypnosis is effective in decreasing pain compared to standard care, especially when used in multiple sessions before the procedure. ^{1 2 3 4 5}

Is the Trauma-Informed Intervention for Procedural Pain (TIPPI-R) generally safe for humans?

The research articles do not provide specific safety data for TIPPI-R, but they discuss related interventions like cognitive behavioral techniques and computer-taught coping methods, which were well-received and considered acceptable by children, parents, and staff in medical settings. ^{6 7 8 9 10}

How does the TIPPI-R treatment differ from other treatments for procedural pain?

TIPPI-R is unique because it incorporates trauma-informed care principles, focusing on understanding and addressing the emotional and psychological needs of patients who have experienced trauma. This approach is different from traditional treatments that primarily focus on physical pain management, as it aims to create a supportive environment that promotes safety, trust, and empowerment for the patient. ^{11 12 13 14 15}

What is the purpose of this trial?

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)

Research Team

Lauren R Hayes, PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Differential Pain Presentations Observed across Post-Traumatic Stress Disorder Symptom Trajectories after Combat Injury. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of patient and caregiver perception of pain from commonly performed accident and emergency services procedures. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Hypnotic versus active cognitive strategies for alleviation of procedural distress in pediatric oncology patients. [2011]

4. England pubmed.ncbi.nlm.nih.gov

Hypnosis for Acute Procedural Pain: A Critical Review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Pain, coping, and adjustment in patients with burns: preliminary findings from a prospective study. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

[Sedation analgesia in interventional radiology]. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events of procedural sedation and analgesia in a pediatric emergency department. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral interventions for children during painful procedures: research challenges and program development. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Computer-taught coping techniques for venepuncture: preliminary findings from usability testing with children, parents and staff. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Pain and anxiety during interventional radiologic procedures: effect of patients' state anxiety at baseline and modulation by nonpharmacologic analgesia adjuncts. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of Evaluations of Trauma-Informed Organizational Interventions That Include Staff Trainings. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Peer-to-Peer Trauma-Informed Training for Surgical Residents Facilitated by Psychiatry Residents. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

How Can a Trauma-Informed Care Approach Be Applied to Patients With Gynecologic Cancer? [2023]

14. United States 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. [2020]

15. United States pubmed.ncbi.nlm.nih.gov

Brief trauma-informed care training to enhance health care providers' knowledge, comfort, and implementation of trauma-informed care in primary care clinics: A pilot effectiveness study. [2023]