Procedural PainTIPPI-RNCT06705491
Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
A study testing TIPPI-R in people with Procedural Pain and Cancer-related Pain, run by University of Louisville at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Procedural Pain, Cancer-related Pain
- What is being tested?
- TIPPI-R
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UK DanceBlue Pediatric Hematology & Oncology
Lexington, Kentucky, 40508
Kentucky Children's Hospital
Lexington, Kentucky, 40536
Norton Children's Cancer Institute
Louisville, Kentucky, 40202
Norton Children's Hospital
Louisville, Kentucky, 40202
About this study
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?
Read more
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)
- Conditions
- Procedural Pain, Cancer-related Pain
- Being tested
- TIPPI-R
- Medical subject headings
- Pain, Procedural, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPPI-RBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TIPPI-R | Experimental | Not described Receives: Behavioral: TIPPI-R |
| Standard of Care | No 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. |
| Non-receipt of intervention | No intervention | Participants will be moved into this arm if they are initially randomized into the intervention arm, but they do not receive the TIPPI-R intervention within the allocated window dictated in the protocol. According to the protocol, consented participants should receive the interventions within 3 weeks of consent. If they do not, the TIPPI-R intervention will not be delivered and the participant will be moved to this arm of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Coping Strategies
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.
Measured: Pain coping strategies will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).
Secondary outcomes (4)
Perceived Pain Intensity
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.
Measured: Perceived pain intensity will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).
Pain Catastrophizing
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.
Measured: 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
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.
Measured: Confidence managing pain and distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).
Distress
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).
Measured: Distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start7 Feb 2025
- Primary completion30 Jun 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Kentucky Cabinet for Health and Family Services, University of Kentucky, Norton Healthcare
- Responsible party
- Principal investigator, Lauren Hayes, University of Louisville
- Investigators
- Lauren R Hayes, PhD, Principal investigator, Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705491
- Sponsor's protocol ID
- 24.0284
- Acronym
- TIPPI-R
- Status last verified
- Aug 2026
- First submitted
- 19 Nov 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tutelman PR, Chambers CT, Stinson JN, Parker JA, Fernandez CV, Witteman HO, Nathan PC, Barwick M, Campbell F, Jibb LA, Irwin K. Pain in Children With Cancer: Prevalence, Characteristics, and Parent Management. Clin J Pain. 2018 Mar;34(3):198-206. doi: 10.1097/AJP.0000000000000531.
PubMed 28678061O'Donnell FT, Rosen KR. Pediatric pain management: a review. Mo Med. 2014 May-Jun;111(3):231-7.
PubMed 25011346Tonning Olsson I, Alberts NM, Li C, Ehrhardt MJ, Mulrooney DA, Liu W, Pappo AS, Bishop MW, Anghelescu DL, Srivastava D, Robison LL, Hudson MM, Ness KK, Krull KR, Brinkman TM. Pain and functional outcomes in adult survivors of childhood cancer: A report from the St. Jude Lifetime Cohort study. Cancer. 2021 May 15;127(10):1679-1689. doi: 10.1002/cncr.33303. Epub 2020 Dec 28.
PubMed 33369896Schwartz LA, Brumley LD. What a Pain: The Impact of Physical Symptoms and Health Management on Pursuit of Personal Goals Among Adolescents with Cancer. J Adolesc Young Adult Oncol. 2017 Mar;6(1):142-149. doi: 10.1089/jayao.2016.0031. Epub 2016 Oct 28.
PubMed 27792462Price J, Kassam-Adams N, Alderfer MA, Christofferson J, Kazak AE. Systematic Review: A Reevaluation and Update of the Integrative (Trajectory) Model of Pediatric Medical Traumatic Stress. J Pediatr Psychol. 2016 Jan-Feb;41(1):86-97. doi: 10.1093/jpepsy/jsv074. Epub 2015 Aug 28.
PubMed 26319585Rosenberg AR, Bradford MC, Junkins CC, Taylor M, Zhou C, Sherr N, Kross E, Curtis JR, Yi-Frazier JP. Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911578. doi: 10.1001/jamanetworkopen.2019.11578.
PubMed 31532518Kearney JA, Salley CG, Muriel AC. Standards of Psychosocial Care for Parents of Children With Cancer. Pediatr Blood Cancer. 2015 Dec;62 Suppl 5(Suppl 5):S632-83. doi: 10.1002/pbc.25761.
PubMed 26700921Uhl K, Burns M, Hale A, Coakley R. The Critical Role of Parents in Pediatric Cancer-Related Pain Management: a Review and Call to Action. Curr Oncol Rep. 2020 Mar 14;22(4):37. doi: 10.1007/s11912-020-0899-7.
PubMed 32172378Marsac ML, Kassam-Adams N, Hildenbrand AK, Nicholls E, Winston FK, Leff SS, Fein J. Implementing a Trauma-Informed Approach in Pediatric Health Care Networks. JAMA Pediatr. 2016 Jan;170(1):70-7. doi: 10.1001/jamapediatrics.2015.2206.
PubMed 26571032Stehl ML, Kazak AE, Alderfer MA, Rodriguez A, Hwang WT, Pai AL, Boeving A, Reilly A. Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis. J Pediatr Psychol. 2009 Sep;34(8):803-16. doi: 10.1093/jpepsy/jsn130. Epub 2008 Dec 17.
PubMed 19091806Kazak AE, Hocking MC, Ittenbach RF, Meadows AT, Hobbie W, DeRosa BW, Leahey A, Kersun L, Reilly A. A revision of the intensity of treatment rating scale: classifying the intensity of pediatric cancer treatment. Pediatr Blood Cancer. 2012 Jul 15;59(1):96-9. doi: 10.1002/pbc.23320. Epub 2011 Aug 19.
PubMed 21858914Stinson JN, Jibb LA, Nguyen C, Nathan PC, Maloney AM, Dupuis LL, Gerstle JT, Hopyan S, Alman BA, Strahlendorf C, Portwine C, Johnston DL. Construct validity and reliability of a real-time multidimensional smartphone app to assess pain in children and adolescents with cancer. Pain. 2015 Dec;156(12):2607-2615. doi: 10.1097/j.pain.0000000000000385.
PubMed 26580680Kohut SA, Stinson J, Chambers CT, Reid GJ, Pillai Riddell RR. The Pain Coping Questionnaire short-form: preliminary reliability and validity. Pain Rep. 2022 Jan 12;7(1):e982. doi: 10.1097/PR9.0000000000000982. eCollection 2022 Jan-Feb.
PubMed 35047713Reid GJ, Gilbert CA, McGrath PJ. The Pain Coping Questionnaire: preliminary validation. Pain. 1998 May;76(1-2):83-96. doi: 10.1016/s0304-3959(98)00029-3.
PubMed 9696461Goubert L, Eccleston C, Vervoort T, Jordan A, Crombez G. Parental catastrophizing about their child's pain. The parent version of the Pain Catastrophizing Scale (PCS-P): a preliminary validation. Pain. 2006 Aug;123(3):254-263. doi: 10.1016/j.pain.2006.02.035. Epub 2006 Apr 27.
PubMed 16644128
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
- ClinicalTrials.gov ID
- NCT06705491
- Acronym / sponsor ID
- TIPPI-R / 24.0284
- Conditions
- Procedural Pain, Cancer-related Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Kentucky Cabinet for Health and Family Services, University of Kentucky, Norton Healthcare
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TIPPI-R | Experimental | Behavioral: TIPPI-R |
| Standard of Care | No 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. |
| Non-receipt of intervention | No intervention | –Participants will be moved into this arm if they are initially randomized into the intervention arm, but they do not receive the TIPPI-R intervention within the allocated window dictated in the protocol. According to the protocol, consented participants should receive the interventions within 3 weeks of consent. If they do not, the TIPPI-R intervention will not be delivered and the participant will be moved to this arm of the study. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIPPI-RThe 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. | Behavioural | TIPPI-R |
Primary outcome
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.
4 secondary outcomes
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).
Pain Catastrophizing
Time frame: 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).
Distress
Time frame: Distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 28678061Tutelman PR, Chambers CT, Stinson JN, Parker JA, Fernandez CV, Witteman HO, Nathan PC, Barwick M, Campbell F, Jibb LA, Irwin K. Pain in Children With Cancer: Prevalence, Characteristics, and Parent Management. Clin J Pain. 2018 Mar;34(3):198-206. doi: 10.1097/AJP.0000000000000531.
- Background: PubMed 25011346O'Donnell FT, Rosen KR. Pediatric pain management: a review. Mo Med. 2014 May-Jun;111(3):231-7.
- Background: PubMed 33369896Tonning Olsson I, Alberts NM, Li C, Ehrhardt MJ, Mulrooney DA, Liu W, Pappo AS, Bishop MW, Anghelescu DL, Srivastava D, Robison LL, Hudson MM, Ness KK, Krull KR, Brinkman TM. Pain and functional outcomes in adult survivors of childhood cancer: A report from the St. Jude Lifetime Cohort study. Cancer. 2021 May 15;127(10):1679-1689. doi: 10.1002/cncr.33303. Epub 2020 Dec 28.
- Background: PubMed 27792462Schwartz LA, Brumley LD. What a Pain: The Impact of Physical Symptoms and Health Management on Pursuit of Personal Goals Among Adolescents with Cancer. J Adolesc Young Adult Oncol. 2017 Mar;6(1):142-149. doi: 10.1089/jayao.2016.0031. Epub 2016 Oct 28.
- Background: PubMed 26319585Price J, Kassam-Adams N, Alderfer MA, Christofferson J, Kazak AE. Systematic Review: A Reevaluation and Update of the Integrative (Trajectory) Model of Pediatric Medical Traumatic Stress. J Pediatr Psychol. 2016 Jan-Feb;41(1):86-97. doi: 10.1093/jpepsy/jsv074. Epub 2015 Aug 28.
- Background: PubMed 31532518Rosenberg AR, Bradford MC, Junkins CC, Taylor M, Zhou C, Sherr N, Kross E, Curtis JR, Yi-Frazier JP. Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911578. doi: 10.1001/jamanetworkopen.2019.11578.
- Background: PubMed 26700921Kearney JA, Salley CG, Muriel AC. Standards of Psychosocial Care for Parents of Children With Cancer. Pediatr Blood Cancer. 2015 Dec;62 Suppl 5(Suppl 5):S632-83. doi: 10.1002/pbc.25761.
- Background: PubMed 32172378Uhl K, Burns M, Hale A, Coakley R. The Critical Role of Parents in Pediatric Cancer-Related Pain Management: a Review and Call to Action. Curr Oncol Rep. 2020 Mar 14;22(4):37. doi: 10.1007/s11912-020-0899-7.
- Background: PubMed 26571032Marsac ML, Kassam-Adams N, Hildenbrand AK, Nicholls E, Winston FK, Leff SS, Fein J. Implementing a Trauma-Informed Approach in Pediatric Health Care Networks. JAMA Pediatr. 2016 Jan;170(1):70-7. doi: 10.1001/jamapediatrics.2015.2206.
- Background: PubMed 19091806Stehl ML, Kazak AE, Alderfer MA, Rodriguez A, Hwang WT, Pai AL, Boeving A, Reilly A. Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis. J Pediatr Psychol. 2009 Sep;34(8):803-16. doi: 10.1093/jpepsy/jsn130. Epub 2008 Dec 17.
- Background: PubMed 21858914Kazak AE, Hocking MC, Ittenbach RF, Meadows AT, Hobbie W, DeRosa BW, Leahey A, Kersun L, Reilly A. A revision of the intensity of treatment rating scale: classifying the intensity of pediatric cancer treatment. Pediatr Blood Cancer. 2012 Jul 15;59(1):96-9. doi: 10.1002/pbc.23320. Epub 2011 Aug 19.
- Background: PubMed 26580680Stinson JN, Jibb LA, Nguyen C, Nathan PC, Maloney AM, Dupuis LL, Gerstle JT, Hopyan S, Alman BA, Strahlendorf C, Portwine C, Johnston DL. Construct validity and reliability of a real-time multidimensional smartphone app to assess pain in children and adolescents with cancer. Pain. 2015 Dec;156(12):2607-2615. doi: 10.1097/j.pain.0000000000000385.
- Individual participant dataSharing planned: No
Related trials for Procedural Pain
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
Not yet recruiting
Effects of Family-Proxy-Selected Natural Sound Therapy Versus Standardized Natural Sound and Noise Reduction on Procedural Pain During Endotracheal Suctioning in Non-Communicative Mechanically Ventilated Adults: A Four-Arm Randomized Controlled Trial
Procedural Pain During Endotracheal Suctioning
RecruitingObservational study
Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia
Procedural Pain, Procedural Sedation and Analgesia
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Not yet recruiting
Leg and Foot Massage for Pain in Newborns Receiving Heel Stick
Procedural Pain in Newborns
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren R Hayes, PhD principal investigator
Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIPPI-R in people with Procedural Pain and Cancer-related Pain, run by University of Louisville at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705491, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.