The Good Pain Consultation in Endometriosis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The Pain Self-Efficacy Questionaire
研究概览
简要总结
This PhD project investigates the effect of "the good pain consultation" and early integration of biopsychosocial pain education with current standard management of endometriosis. Our goal is to facilitate self-management of pain and improve health-related quality of life (HRQOL) using limited resources.
Our research question is: Does a good pain consultation improve pain self-efficacy and HRQOL, compared to usual care at 3 months and 1 year.?
Researchers will compare a good pain consultation to a control group that will receive usual care.
Participants will:
Attend a consultation and biopsychososial pain education plus usual care or usual care alone.
They will answer questions in an internet-based questionnaires three times point during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinded outcome assessment and data analysis. Manuscript first draft will be written blinded.
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •biological women
排除标准
- •not speaking norwegian
研究组 & 干预措施
intervention group
pain consultation, biopsychosocial pain education + usual care
干预措施: pain consultation, biopsychosocial pain education + usual care (Other)
control group
usual care
干预措施: Usual Care (Other)
结局指标
主要结局
The Pain Self-Efficacy Questionaire
时间窗: The participants will report the outcome measures at baseline, after 3 and after 12 months.
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10 item self-report questionnaire which assesses confidence people with ongoing pain have in performing activities despite pain. Self-efficacy regarding household chores, socializing, work and coping without medication are assessed. Each item is scored on a 6-point scale, for a total raw score of 0-10 where high scores indicate greater levels of confidence in dealing with pain. The PSEQ is translated to Norwegian and used in previous Norwegian studies.
次要结局
- The Short Form-12/Rand 12 Health Survey(The participants will report the outcome measures at baseline, after 3 and after 12 months.)
- A single question about Quality of Life(The participants will report the outcome measures at baseline, after 3 and after 12 months.)
- Pain catastrophizing scale (PCS)(The participants will report the outcome measures at baseline, after 3 and after 12 months.)
- The Hopkins Symptom Checklist (HSCL-10).(The participants will report the outcome measures at baseline, after 3 and after 12 months.)
- Numeric rating scales (NRS)(The participants will report the outcome measures at baseline, after 3 and after 12 months.)
- The Decreased Sexual Desire Screener (DSDS)(The participants will report the outcome measures at baseline, after 3 and after 12 months.)
- The Brief Illness Perception Questionnaire (Brief IPQ)(The participants will report the outcome measures at baseline, after 3 and after 12 months.)
- 2016 Fibromyalgia diagnostic criteria(The participants will report the outcome measures at baseline, after 3 and after 12 months.)
- Other questions(The participants will report the outcome measures at baseline and after 12 months.)
- intention to reconsult and use of healthcare services(The participants will report the outcome measures at baseline and after 12 months)