ISRCTN91641999进行中(未招募)Unknown
PIIPeR Trial: Impact of Paediatric Intensive Interdisciplinary Pain Rehabilitation for children with chronic pain and pain-related disability: Feasibility of recruitment to a randomised trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中(未招募)
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. CYP aged 11-18 years with chronic pain (>3 months duration) following referral to, and multidisciplinary assessment at, the GOSH Chronic Pain Clinic. Eligibility will not be influenced by biological sex, gender, ethnicity, or socioeconomic grouping.
- •2. Willing and able to provide written informed Participant consent/assent and Parental consent
- •3. Fulfil at least 3 of the 4 criteria:
- •3.1. Significant pain-related disability (PedsQL quality of life total score <70)
- •3.2. High levels of pain catastrophising (Pain Catastrophizing Scale score > 20)
- •3.3. School attendance <90%
- •3.4. Psychological (Pediatric Index of Emotional Distress score >20) and/or physical (specialist physiotherapy assessment of reduction in mobility and muscle strength) comorbidity
排除标准
- •1. Unwilling/unable to provide written informed Participant consent/assent and/or Parental consent
- •2. Non-engagement and/or not willing to accept biopsychosocial formulation and management plan
- •3. Major psychological or psychiatric illness (personality disorder, severe depression, eating disorder) that requires specific therapy
- •4. Other acute intercurrent illness/infection that precludes involvement in group activities or ability to attend full-time Participant Timetable
- •5. Parent/carer unable to attend for joint and parallel Parent Timetable
- •6. Severe limitation of mobility due to an intercurrent medical condition that precludes involvement in group activities (based on the clinical history and medical and physiotherapy assessment)
- •7. Any primary psychological disorder likely to interfere with engagement with the intervention including, but not limited to: externalising conduct disorder, chronic fatigue syndrome, functional neurological disorder, and eating disorders (based on clinical psychology assessment at Chronic Pain Clinic and by PPRP clinical staff).
- •8. Significant limitations in understanding written and verbal English that would preclude the participant's engagement in group activities and verbal discussions. As patients referred to GOSH Pain Clinic are usually attending UK schools, this exclusion would be rare. Parental language barriers are relative exclusion criteria. In line with current clinical practice, information for parents and consent can be obtained with interpreters, and some educational material can be translated from English. The extent to which parental understanding of verbal English would limit engagement in parent sessions and skills training would be assessed on an individual basis.
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