Exploring the Link Between Pain and Distress in Adolescent Patients with Chronic Pain

NCT04261114 | Completed

• 1 other identifier: PID14553-SP001-AC001
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic pain; Adolescents; Emotional distress; Burdensomeness; Self-harm; Hopelessness

Outcome Measures

Primary Outcomes (1)

• Perceived burdensomeness

  Interpersonal Needs Questionnaire (INQ), completed by the adolescents. Scores range from 1="not at all true for me" to 7="very true for me", with higher scores indicating more perceived burdensomeness.

  at baseline

Secondary Outcomes (4)

• Perceived burdensomeness

  at 7-day follow-up

• Hopelessness

  at baseline

• Hopelessness

  at 7-day follow-up

• Thoughts and acts of self-harm

  at baseline

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

77 Adolescents with chronic pain and their parents/ caregivers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Oxford University Hospitals NHS Trust: collaborator
• Oskar-Helene-Heim Foundation: collaborator

Study Sites (1)

Oxford Centre for Children and Young People in Pain

Oxford, Oxfordshire, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: June 13, 2022
• Primary Completion: June 12, 2023
• Study Completion: March 28, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

GB (1)