Clinical trial NCT04261114: Exploring the Link Between Pain and Distress in Adolescent Patients with Chronic Pain
Official title: Exploring the Relationship Between Physical Pain and Emotional Distress in Adolescents with Chronic Pain - a Three-step Observational Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Chronic pain
Adolescents
Emotional distress
Burdensomeness
Self-harm
Hopelessness
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
name: Oskar-Helene-Heim Foundation
First posted: 2020-02-07
Enrollment: 77
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 77 Adolescents with chronic pain and their parents/ caregivers

Brief summary: The primary aim is to explore what it is about the experience of chronic pain that may cause emotional distress in some young people but not in others, and how particular individual characteristics, as well as family factors may contribute to young persons' pain experiences and their emotional responses to pain.

Detailed description: This is a three-part observational follow-up study:

Part one will explore (a) whether the current sample reports emotional distress, including feelings of burdensomeness, hopelessness and thoughts and acts of self-harm, and if young people perceive there to be a link between pain and any such feelings of distress, and (b) which aspects of the pain experience, if any, are associated with such distress, using qualitative and quantitative data.

Part two will explore potential individual-level and family-level risk and resilience factors underpinning the hypothesised relationship between aspects of the pain experience and burdensomeness, hopelessness and thoughts and acts of self-harm, using adolescent and parental baseline data.

In part three, adolescent participants will be invited to complete daily diaries on their pain experience, three times per day over 7 days, in order to investigate which aspects of the pain experience are associated with burdensomeness and hopelessness at follow-up.

This study has the potential to improve the care of young people with chronic pain, and in particular the emotional support that young people receive.

Eligibility criteria: Inclusion Criteria:

Part 1: Adolescents

* Participant is willing and able to give assent (aged 12-15) or informed consent (aged =\>16) for participation in the study
* Adolescents aged 12 to 19 years
* Self-reported experience of chronic pain (i.e., recurrent and/or persistent pain at least once per week for at least 3 months).
* Able to read and converse fluently in English
* Parent/carer willing to give informed consent for participants aged 12-15

Part 2: Adults

* Participant is willing and able to give informed consent for participation in the study.
* Participant is the parent/carer for a child aged 12 to 19 years, with chronic pain (i.e., recurrent or persistent pain at least once per week for the past 3 months), and this child is participating in this study.
* Able to read and converse fluently in English

Additional criteria for Part 3: Follow-up part

· In possession of a smartphone to complete the momentary assessments.

Exclusion Criteria:

Part 1: Adolescents

* If some type of serious pathology (e.g., infection, fracture, disease process (e.g., cancer)) or surgical procedure is the cause of the resulting pain complaint.
* If the patient is too psychologically unstable (e.g., experience of hallucinations or delusions, or with known acute suicide risk) to safely participate in this research, based on clinical judgment.

Part 2: Adults

-If the clinical care team thinks the parent/ caregiver is unsuitable for this study.

Additional criteria for Part 3: Follow-up part

-Inability to provide data via the use of a smartphone

Primary outcomes:
measure: Perceived burdensomeness
timeFrame: at baseline
Secondary outcomes:
measure: Perceived burdensomeness
timeFrame: at 7-day follow-up
measure: Hopelessness
timeFrame: at baseline
measure: Hopelessness
timeFrame: at 7-day follow-up
measure: Thoughts and acts of self-harm
timeFrame: at baseline
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Centre for Children and Young People in Pain
state: Oxfordshire
Study officials:
References: