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

• Conditions: Chronic Pain

• Registration Number: NCT04261114
• Lead Sponsor: University of Oxford

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.

Study Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Study Start: 2022-06-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16
• Primary Completion: 2023-06
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceived burdensomeness	at baseline	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.

Secondary Outcome Measures

Name	Time	Method
Hopelessness	at 7-day follow-up	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.
Perceived burdensomeness	at 7-day follow-up	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.
Thoughts and acts of self-harm	at baseline	4 single items on the presence/ absence of self-harm thoughts and acts, completed by the adolescents.

Trial Locations

Locations (1)

Oxford Centre for Children and Young People in Pain; 🇬🇧 Oxford, Oxfordshire, United Kingdom