Open -Label Placebo for Non-specific Pain in the Emergency Department: Study Protocol for a Mixed-method Randomised Control Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Rate of patients completing their outcome (self-)assessments (i.e. questionnaires)
研究概览
简要总结
The aim of this study is to assess whether an intervention with open-label placebo (OLP) for non-specific pain in the emergency department is feasible.
详细描述
This project is a collaboration between the Emergency Department at the University Hospital of Basel and the Faculty of Psychology at the University of Basel. The investigation will analyze whether an intervention consisting of open-label placebo tablets is feasible for patients with non-specific pain in the emergency department. Open-label placebos are administered without deception, meaning the patients are aware they are taking a placebo. Patients will be randomized into intervention group (OLP) or control group (treatment as usual) with ibuprofen. The study duration for patients is 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of non-specific acute pain
- •Able to understand the study and its outcome measures
- •Signed informed consent
- •18 years or older
- •Sufficient German language skills
排除标准
- •Chronic pain
- •Treatment with pain medication for > 7 days prior to ED visit
- •Known allergy or intolerance to ibuprofen
- •Known hereditary galactose-intolerance, lactase deficiency or glucosegalactose malabsorption
- •Participation in another clinical trial with medicinal products
- •Need for hospitalization
- •Known pregnancy
研究组 & 干预措施
Open-label Placebo
Treatment with open-label placebo pills 3x/day
干预措施: Placebo (open-label) (Other)
Treatment as usual
Treatment as usual defined as Ibuprofen 3x/day
干预措施: Ibuprofen 400 mg (Drug)
结局指标
主要结局
Rate of patients completing their outcome (self-)assessments (i.e. questionnaires)
时间窗: 30 days
Feasibility Outcome. Threshold: ≥80% of patients with completed assessments/questionnaires..
Rate of eligible patients consenting to participate
时间窗: 12 months
Feasibility Outcome. Threshold: ≥30% of eligible patients for the target population of 50 patients within 12 months.
Rate of patients adhering to the study protocol in terms of medication intake
时间窗: 7 days
Feasibility Outcome. Threshold: ≥70% of patients with at least ≥70% medication intake according to the protocol.
Rate of patients' satisfaction with the intervention and study procedure
时间窗: 30 days
Feasibility Outcome. Threshold: ≥70% of patients with a score ≥6 on a scale from 0 (absolutely not satisfied) to 10 (absolutely satisfied).
次要结局
- Change in pain intensity as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)(8 days)
- Change in pain interference as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)(8 days)
- Use of rescue medication(8 days)
- Frequency and nature of side effects, adverse events(30 days)
- Rate of patients with ED re-attendance(30 days)
- Average pain intensity 30 days after the ED index visit(30 days)
- Average pain interference 30 days after the ED index visit(30 days)
- Frequency of medication use between day 8 and 30(30 days)
- Rate of patients with specific cause of pain within 30 days of the index visit(30 days)
- Depression measured by depression scale of the German version of the Patient Health Questionnaire (PHQ-9) at different timepoints.(30 days)
研究者
Bruno Minotti
Sponsor Investigator, University Hospital Basel, Emergency Department
University Hospital, Basel, Switzerland