Distress in Adolescents With Chronic Pain: Who is at Risk, When, and Why

NCT06619171 | Enrolling By Invitation

• 4 other identifiers: PID 17920IRAS 341501CPMS 64178MRF-FEL-CAMPCF-23-105
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

Living with chronic pain can be tough for any young person. But while some young people may experience distressing thoughts, others may not. No young person should face these problems alone. So, it's important to better understand who might be more vulnerable to distress, when, and why. That way, healthcare professionals can be there for vulnerable youth when they need it most. In total, 70 young people with chronic pain (aged 12-19 years) will be invited to take part. Over a 30-day period, they will answer a few questions about their pain and feelings five times per day (experience sampling part) and complete three detailed surveys (at the start, in the middle, and at the end). This will help the investigators better understand how feelings of pain and distress might change over hours, days, and weeks. Plus, it might reveal which psychological and social factors might bring about these changes. Answering these questions is vital as it will help healthcare professionals make sure vulnerable young people get the right care at the right time.

Conditions

Chronic Pain

Keywords

Adolescents; Chronic Pain; Distress; Self-Harm; Suicidality; Experience Sampling

Outcome Measures

Primary Outcomes (3)

• Hopelessness

  Hopelessness Scale for Children (HSC; 17 items) Response options: 1=True, 0=False (total score range: 0-17) The higher the score, the greater the hopelessness for the future.

  day 0 (baseline), 15 (interim survey), and day 31 (final survey)

• Entrapment

  Short Defeat and Entrapment Scale (4 item entrapment subscale) Response options: 0 = not at all, 1 = a little bit, 2 = moderately, 3 = quite a bit, 4 = extremely like me (total score range: 0-16) Higher scores indicate greater feelings of entrapment.

  day 0 (baseline), 15 (interim survey), and day 31 (final survey)

• Suicidal and self-harm thoughts and behaviours

  10 separate items on the presence/ absence of suicidal and self-harm thoughts and behaviours.

  day 0 (baseline), 15 (interim survey), and day 31 (final survey)

Secondary Outcomes (3)

• Hopelessness

  day 1 to 30

• Entrapment

  day 1 to 30

• Suicidal and self-harm thoughts and behaviours

  day 1 to 30

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We aim to recruit 70 adolescents (aged 12-19 years) with chronic pain.

You may qualify if:

• Participant is willing and able to give assent (aged 12-15 years) or informed consent (aged 16 years and older) for participation in the study,
• Parent/guardian is willing to give informed consent for participants aged 12-15 years.
• Adolescents aged 12 to 19 years.
• Were accepted for assessment at a tertiary specialist paediatric pain service, indicating by definition that they experience long-standing, treatment-resistant chronic pain that is functionally interfering.
• Able to read and converse fluently in English.
• Participant is willing to install the m-Path app on a smartphone that runs on Android or iOS to complete the daily assessments. (Please note that a recent Ofcom report has shown that by the age of 12 years, 98% of young people in the UK have their own mobile phone, used by 93% to access social media apps or sites. This supports the nearly universal access of smartphones in this age group)

You may not qualify if:

• If some serious acute pathology (e.g., infection, fracture, disease process (e.g., cancer with a potentially fatal trajectory)) or surgical procedure is the cause of the resulting pain complaint.
• If the patient is too psychologically unstable to safely participate in this research, based on clinical judgment (e.g., experiences of acute psychosis)

Sponsors & Collaborators

• University of Oxford: lead
• Versus Arthritis: collaborator
• Medical Research Foundation: collaborator
• Royal United Hospitals Bath NHS Foundation Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (2)

Bath Centre for Pain Services [BCPS]

Bath, United Kingdom

Location

Oxford Centre for Children and Young People in Pain [OxCYPP]

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain; Self-Injurious Behavior; Suicidal Ideation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Suicide

Study Officials

• Verena Hinze, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 22, 2024
• Primary Completion: August 1, 2025
• Study Completion: April 1, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

GB (2)