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

Exploring the Relationship Between Physical Pain and Emotional Distress in Adolescents With Chronic Pain - A Three-step Observational Follow-up Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic 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.

• Study Type: Observational
• Enrollment (Anticipated): 77

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom
      • Oxford Centre for Children and Young People in Pain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

77 Adolescents with chronic pain and their parents/ caregivers

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 7-day follow-up
Hopelessness	Hopelessness Scale for Children (HSC), completed by the adolescents. Participants score each item as 1=True and 0=False. The higher the score, the greater the hopelessness for the future.	at baseline
Hopelessness	Hopelessness Scale for Children (HSC), completed by the adolescents. Participants score each item as 1=True and 0=False. The higher the score, the greater the hopelessness for the future.	at 7-day follow-up
Thoughts and acts of self-harm	4 single items on the presence/ absence of self-harm thoughts and acts, completed by the adolescents.	at baseline

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Oxford University Hospitals NHS Trust; Oskar-Helene-Heim Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Chronic pain; Emotional distress; Hopelessness; Self-harm; Burdensomeness
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: PID14553-SP001-AC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The syntax code and a fully de-identified version of the final dataset may be shared with third parties to support future related research where it is in the public interest.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No