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Paediatric Breakthrough Pain Assessment

NCT06790719 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2025-01-24

No results posted yet for this study

Summary

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.

Conditions

  • Breakthrough Pain
  • Palliative Medicine
  • Oncology Pain
  • Pediatric ALL
  • Young People

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • University of Southampton

    lead OTHER

Principal Investigators

  • Christina Liossi, DPsych · University of Southampton

Eligibility

Min Age
8 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06790719 on ClinicalTrials.gov