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| Name | Class |
|---|---|
| Roland Bingisser, Principal Investigator, Head of Emergency Department, University Hospital Basel | UNKNOWN |
| Jens Gaab, Co-investigator, Head of Division University of Basel, Faculty of Psychology | UNKNOWN |
| Bojana Degen, Co-investigator, University of Basel, Faculty of Psychology |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label Placebo | Experimental | Treatment with open-label placebo pills 3x/day |
|
| Treatment as usual | Active Comparator | Treatment as usual defined as Ibuprofen 3x/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (open-label) | Other | P-Tabletten weiss 10mm (Lichtenstein, Zentiva) pills 3x/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of eligible patients consenting to participate | Feasibility Outcome. Threshold: ≥30% of eligible patients for the target population of 50 patients within 12 months. | 12 months |
| Rate of patients adhering to the study protocol in terms of medication intake | Feasibility Outcome. Threshold: ≥70% of patients with at least ≥70% medication intake according to the protocol. | 7 days |
| Rate of patients completing their outcome (self-)assessments (i.e. questionnaires) | Feasibility Outcome. Threshold: ≥80% of patients with completed assessments/questionnaires.. | 30 days |
| Rate of patients' satisfaction with the intervention and study procedure | Feasibility Outcome. Threshold: ≥70% of patients with a score ≥6 on a scale from 0 (absolutely not satisfied) to 10 (absolutely satisfied). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF) | Clinical Outcome (exploratory). Score from 0 (no pain) to 10 (worste pain ever) for each pain severity subscale of the BPI-SF (minimal, average, and maximal pain intensity in the last 24 hours). | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of eligible patients declining consent | Additional variables of interests. If communicated (NOTE: not mandatory according to Good Clinical Practice), the reason for declining will also be recorded for anonymous qualitative analysis. | 1 day |
| Expectancy of Pain Relief Scale on the day of index visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Minotti, MD | Emergency Department, University Hospital Basel, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40132833 | Derived | Degen B, Szczesna A, Nickel CH, Bingisser R, Gaab J, Minotti B. Open-label placebo for non-specific pain in the emergency department (OLP EM): study protocol for a mixed-method randomised control feasibility study in Switzerland. BMJ Open. 2025 Mar 25;15(3):e090508. doi: 10.1136/bmjopen-2024-090508. |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| UNKNOWN |
| Anna Szczesna, Co-investigator, University Hospital Basel, Emergency Department | UNKNOWN |
| Christian H Nickel, Co-investigator, Deputy Head of Emergency Department, University Hospital Basel | UNKNOWN |
mixed-method randomised control feasibility study
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| Ibuprofen 400 mg | Drug | Ibuprofen pills 3x/day |
|
|
| Change in pain interference as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF) |
Clinical Outcome (exploratory). Score from 0 (no impact of pain) to 10 (maximal impact of pain) for each pain interference subscale of the BPI-SF (impact of pain in the last 24 hours on mood, sleep, activity, work, social relationships, enjoyment of life). |
| 8 days |
| Use of rescue medication | Clinical Outcome (exploratory). Proportion of patients requiring rescue medication (including amount of rescue medication intake) in both arms during the first 8 days. | 8 days |
| Frequency and nature of side effects, adverse events | Clinical Outcome (exploratory) | 30 days |
| Rate of patients with ED re-attendance | Clinical Outcome (exploratory) | 30 days |
| Average pain intensity 30 days after the ED index visit | Clinical Outcome (exploratory). Measured with a score from 0 (no pain) to 10 (worste pain ever) for each pain severity subscale of the BPI-SF (minimal, average, and maximal pain in the last 24 hours). | 30 days |
| Average pain interference 30 days after the ED index visit | Clinical Outcome (exploratory). Measured with a score from 0 (no impact) to 10 (maximal impact) for each pain interference subscale of the BPI-SF (impact of pain in the last 24 hours on mood, sleep, activity, work, social relationships, enjoyment of life). | 30 days |
| Frequency of medication use between day 8 and 30 | Clinical Outcome (exploratory). Frequency of (optional) medication use between day 8 and 30. | 30 days |
| Rate of patients with specific cause of pain within 30 days of the index visit | Clinical Outcome (exploratory). Rate and type of diagnosis of a specific cause of pain following the index visit (i.e. in the course, e.g. appendicitis diagnosed after presenting with "non-specific abdominal pain" at the index visit). | 30 days |
| Depression measured by depression scale of the German version of the Patient Health Questionnaire (PHQ-9) at different timepoints. | Clinical Outcome (exploratory). PHQ-9 score from 0 (no depression) to 27 (severe depression). | 30 days |
Additional variables of interests. Score from 0 (no expectancy of pain relief) to 10 (maximum expectancy of pain relief). |
| 1 day |
| Desire for Pain Relief Scale on the day of index visit | Additional variables of interests. Score from 0 (no desire of pain relief) to 10 (maximum desire of pain relief). | 1 day |
| Placebo understanding during day of index visit | Additional variables of interests. Qualitative analysis (open questions) on placebo understanding. | 1 day |
| Placebo beliefs during day of index visit | Additional variables of interests. Qualitative analysis (open questions) on placebo beliefs. | 1 day |
| Placebo intervention credibility during the index visit | Additional variables of interests. Qualitative analysis (open questions) on placebo credibility. | 1 day |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |