NCT06790719Not yet recruiting
Paediatric Breakthrough Pain Assessment
Development and Validation of a Paediatric Breakthrough Pain Assessment Tool
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Many children and young people with life-limiting and life-threatening illnesses get sudden bursts of pain called breakthrough pain. At the moment, there aren't any good ways to measure this pain in children and young people. The investigators are developing two questionnaires to help: one for patients to fill out themselves and another for parents or healthcare professionals to complete for younger children and young people who cannot explain their pain for themselves. The investigators plan to work with 210 people across hospitals and hospices in England and Wales. This includes children and young people with life-limiting and life-threatening illnesses, their caregivers, and healthcare professionals. The investigators have already made a first version of the questionnaires. The project has three main Studies: In Study 1, the investigators will talk to 5-10 young patients and 5-10 caregivers about their experiences with breakthrough pain. The investigators will use their feedback to improve the questionnaires. In Study 2, the investigators will ask 5-10 patients, 5-10 caregivers, and 5-10 healthcare professionals to fill out the questionnaires while speaking their thoughts out loud. This will help the investigators find any parts that are confusing or difficult to understand. In Study 3, the investigators will test how well the questionnaires works. 80 patients, 40 caregivers, and 40 healthcare professionals will complete the questionnaires three different times to make sure they measure breakthrough pain as accurately as possible. These questionnaire will be useful for hospitals and hospices across England and Wales to help them better manage pain, including breakthrough pain, in patients aged 3 months to 25 years who have life-limiting and life-threatening illnesses.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 210 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- 20 Jan 2025
- Primary completion date
- Dec 2025
- Lead sponsor
- University of Southampton
- NCT number
- NCT06790719
What you commit to
- Study type: Observational
- Planned participants: 210
- From 20 Jan 2025 to the primary completion date, Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- • Children, young people, parents and caregivers with limited ability to communicate and read in English.
- Children and young people judged by caregivers or healthcare professionals to lack capacity to take part, who are too unwell, or might find it too distressing.
- Parents and caregivers judged by healthcare professionals to lack capacity to consent, or to be 'struggling' too much. However, if they wish to take part, they can send an email or text message to the study email account or mobile phone.
Who the study is looking for
- Children and young people aged 8-25 years who have experienced 1) background pain related to a life limiting or life threatening condition and 2) around-the-clock analgesia prescribed for the previous week, as confirmed by their healthcare team (Studies 1, 2, and 3).
- Children and young people must be able to communicate and read in English at a level close to, or in line with their chronological age.
- For study 1, non-verbal children and young people, or those with limited verbal ability, will be recruited if they are happy to participate using the Microsoft Teams chat function.
- Parents and caregivers of children and young people aged 3-month-25-years who have experienced 1) background pain related to a life limiting or life threatening condition and 2) around-the-clock analgesia prescribed for the previous week, as confirmed by their healthcare team. (Studies 1, 2, and 3).
- Caregivers can be caring for verbal, non-verbal, or pre-verbal children with or without cognitive or developmental difficulties of any level.
- Parents and caregivers must have self-reported full or partial responsibility for assessing the child or young person's pain.
- Healthcare professionals in primary, secondary and tertiary care who are involved in the care of children and young people with life limiting or life threatening conditions (Studies 2 and 3).
Age in the registry: 8 years to 99 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.