Exploring the Relationship Between Physical Pain and Emotional Distress in Adolescents With Chronic Pain - A Three-step Observational Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Perceived burdensomeness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Perceived burdensomeness
时间窗: 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.
次要结局
- Hopelessness(at 7-day follow-up)
- Perceived burdensomeness(at 7-day follow-up)
- Thoughts and acts of self-harm(at baseline)
研究者
VerenaHinze
Principal Investigator
University of Oxford