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Clinical Trials/NCT04261114
NCT04261114
Enrolling By Invitation
Not Applicable

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

University of Oxford1 site in 1 country77 target enrollmentJune 13, 2022
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Oxford
Enrollment
77
Locations
1
Primary Endpoint
Perceived burdensomeness
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 13, 2022
End Date
July 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

VerenaHinze

Principal Investigator

University of Oxford

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

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

Outcomes

Primary Outcomes

Perceived burdensomeness

Time Frame: 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 Outcomes

  • Hopelessness(at 7-day follow-up)
  • Perceived burdensomeness(at 7-day follow-up)
  • Thoughts and acts of self-harm(at baseline)

Study Sites (1)

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