The PediQUEST Response to Pain Of Children With Neurologic Disability Pilot Randomized Controlled Trial
CompletedNot applicableNCT06075797
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The goal of this pilot randomized controlled trial is to test the feasibility of running a full scale randomized controlled trial that compares the effect of the PQ-ResPOND intervention versus usual care to improve recurrent pain in children, adolescents, and young adults with severe neurologic impairment. The main questions it aims to answer are: * Is the study feasible and acceptable for participants? * Does PQ-ResPOND have a potential to be effective? Participants will: * answer surveys (their parents will) telling us about the child's pain, symptoms, and use of complementary therapies, and about their own psychological distress and satisfaction with care. * a group will receive the PQ-ResPOND intervention which consists of: * activating parents and providers by using the PediQUEST system, a web platform that administers surveys and generates feedback reports alerting parents and providers about the child's experience, AND * responding to child pain or discomfort by incorporating the Response team (members of the hospital's palliative care team) into the child's care to privde a standardized approach to managing recurrent pain. Researchers will use a comparison (control) group consisting of participants who will answer surveys and receive usual care (no feedback reports or consult with palliative care in this group) to see if a randomized design is feasible.
Study details
- Official title
- Feasibility of The PediQUEST Response to Pain Of Children With Neurologic Disability (PQ-ResPOND) Intervention: a Pilot Randomized Controlled Trial (RCT)
- Conditions
- Cerebral Palsy Infantile
- Disabilities Multiple
- Pain
- Interventions
- Behavioral: PediQUEST ResPOND
- Sponsor
- Massachusetts General Hospital
- Collaborators
- National Institute of Nursing Research (NINR); Boston Children's Hospital; Dana-Farber Cancer Institute; University of Alabama at Birmingham; Deakin University
- Start date
- 2024-05-08
- Primary completion
- 2025-07-15
- Sex
- All
- Age range
- from 1 Year
- Results posted
- No results posted in this snapshot
- Countries
- Australia, United States
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Parent-child dyads will be included based on the following criteria: Child participants will be selected from the base population of patients who are: * ≥ 1 year old, * receiving routine (ongoing) care at Boston Children's Hospital, AND * followed by the Neurology, Cerebral Palsy or Complex Care services. All patients from the base population will be screened to include any patient who: * has severe neurological impairment, defined as: * a Central Nervous System disorder resulting in motor and cognitive impairment and an inability to communicate either verbally or through sign language, AND * has complete caregiver dependency for activities of daily living AND * date of diagnosis of SNI is ≥ 4 months prior to the date of screening Exclusion Criteria: * Parent-child dyads will be excluded if any of the following apply: * the child, * is already followed by the palliative care team, OR * is not expected to survive at least 2 months after enrollment; OR * does not have "moderate to severe recurrent pain", as measured through the baseline Child Pain Survey (PPP). Specifically, we will exclude participants whose: * "Good days" AND "Difficult days" PPP scores are \<14, AND * "Most troublesome pain" PPP score is \<30, AND * Number of "difficult days" are \<8 in past month, AND * Number of days with "most troublesome pain" are \<4 in past month; OR • both parents, * do not have legal guardianship, OR * are unable to read, write, and speak English OR Spanish * are unable to understand and complete surveys.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06075797