Patients' Attitudes Towards Open-Label Placebo Implementation Into Clinical Practice

Study Overview
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Brief Summary
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The aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. A qualitative approach is used and online focus group discussions (FGD) with patients with different clinical conditions, entailing chronic back pain, Parkinson's disease, chronic migraine, chemotherapy induced emesis, and menopausal complaints are conducted.

Detailed Description
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Substantial placebo effects have been known for several decades for a multitude of physical as well as psychological complaints. It is essential to test the acceptability of Open-label placebos (OLPs) of patients and health professionals. The aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. A qualitative approach is used and online focus group discussions (FGD) with patients with different clinical conditions, entailing chronic back pain, Parkinson's disease, chronic migraine, chemotherapy induced emesis, and menopausal complaints are conducted. A semi-structured topic guide with open-ended questions will be used.

Official Title
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Patients' Attitudes Towards Open-Label Placebo Implementation Into Clinical Practice

Conditions
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Open-label Placebos

Intervention / Treatment
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* Other: focus group discussions (FGD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed Consent form (see Appendix) Capable of consent (language/cognitive) At least 18 years of age Ability to attend an online conference in regard of physical and psychological condition and technical knowhow and equipment In addition, participants have to be affected by one of the following conditions/disorders: Chronic back pain Chemotherapy-induced emesis (last occurrence at least before 14 days and at maximum before one year) Chronic migraine Parkinson's disease Clinically significant menopausal complaints Exclusion Criteria: Severe ailment and medication side-effects which would interfere with study participation (e.g., due to concentration impairment) Acute psychological crisis which would affect study participation essentially or suicidality Co-morbidity that overlaps in symptoms with the symptoms necessary for inclusion Essential psychiatric disorders other than moderate depression

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic back pain<br> | Other: focus group discussions (FGD)<br>* FGD to explore patients' attitudes/ concerns towards OLP implementation into clinical practice by means of assessment of qualitative information: 1) Patients' attitudes towards clinical usage of OLPs 2) Personal acceptance of OLP intervention 3) Perceived ideas, concerns regarding OLP implementation. Core questions: 1) Attitudes: After all that I told you about placebos, i.e. that there is a concept that patients are openly elucidated that they receive placebos: What does this elicit in you/What is your opinion on this? How do you like the idea? 2) Context of Acceptance: Under which conditions would you personally take placebos knowing that they are placebos? 3) Concerns: Why would you not take openly administered placebos? 4) Ideas for clinical implication: How could an open placebo intervention look like in the hospital? Where could it be possible to receive placebos and how could a placebo intervention in the best manner take place? What would be important from your point of view?<br>|
| Clinically significant menopausal complaints<br> | Other: focus group discussions (FGD)<br>* FGD to explore patients' attitudes/ concerns towards OLP implementation into clinical practice by means of assessment of qualitative information: 1) Patients' attitudes towards clinical usage of OLPs 2) Personal acceptance of OLP intervention 3) Perceived ideas, concerns regarding OLP implementation. Core questions: 1) Attitudes: After all that I told you about placebos, i.e. that there is a concept that patients are openly elucidated that they receive placebos: What does this elicit in you/What is your opinion on this? How do you like the idea? 2) Context of Acceptance: Under which conditions would you personally take placebos knowing that they are placebos? 3) Concerns: Why would you not take openly administered placebos? 4) Ideas for clinical implication: How could an open placebo intervention look like in the hospital? Where could it be possible to receive placebos and how could a placebo intervention in the best manner take place? What would be important from your point of view?<br>|
| Parkinson's disease<br> | Other: focus group discussions (FGD)<br>* FGD to explore patients' attitudes/ concerns towards OLP implementation into clinical practice by means of assessment of qualitative information: 1) Patients' attitudes towards clinical usage of OLPs 2) Personal acceptance of OLP intervention 3) Perceived ideas, concerns regarding OLP implementation. Core questions: 1) Attitudes: After all that I told you about placebos, i.e. that there is a concept that patients are openly elucidated that they receive placebos: What does this elicit in you/What is your opinion on this? How do you like the idea? 2) Context of Acceptance: Under which conditions would you personally take placebos knowing that they are placebos? 3) Concerns: Why would you not take openly administered placebos? 4) Ideas for clinical implication: How could an open placebo intervention look like in the hospital? Where could it be possible to receive placebos and how could a placebo intervention in the best manner take place? What would be important from your point of view?<br>|
| Migraine<br> | Other: focus group discussions (FGD)<br>* FGD to explore patients' attitudes/ concerns towards OLP implementation into clinical practice by means of assessment of qualitative information: 1) Patients' attitudes towards clinical usage of OLPs 2) Personal acceptance of OLP intervention 3) Perceived ideas, concerns regarding OLP implementation. Core questions: 1) Attitudes: After all that I told you about placebos, i.e. that there is a concept that patients are openly elucidated that they receive placebos: What does this elicit in you/What is your opinion on this? How do you like the idea? 2) Context of Acceptance: Under which conditions would you personally take placebos knowing that they are placebos? 3) Concerns: Why would you not take openly administered placebos? 4) Ideas for clinical implication: How could an open placebo intervention look like in the hospital? Where could it be possible to receive placebos and how could a placebo intervention in the best manner take place? What would be important from your point of view?<br>|
| Cancer-related emesis/nausea<br> | Other: focus group discussions (FGD)<br>* FGD to explore patients' attitudes/ concerns towards OLP implementation into clinical practice by means of assessment of qualitative information: 1) Patients' attitudes towards clinical usage of OLPs 2) Personal acceptance of OLP intervention 3) Perceived ideas, concerns regarding OLP implementation. Core questions: 1) Attitudes: After all that I told you about placebos, i.e. that there is a concept that patients are openly elucidated that they receive placebos: What does this elicit in you/What is your opinion on this? How do you like the idea? 2) Context of Acceptance: Under which conditions would you personally take placebos knowing that they are placebos? 3) Concerns: Why would you not take openly administered placebos? 4) Ideas for clinical implication: How could an open placebo intervention look like in the hospital? Where could it be possible to receive placebos and how could a placebo intervention in the best manner take place? What would be important from your point of view?<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative data analysis | Qualitative data analysis using the approach of Thematic Analysis. This approach helps to identify, analyze, and interpret patterns of meanings in the form of upcoming themes in the qualitative data. Important themes deriving from the group discussion between the respective patient groups are explored. . In this manner, important subjective factors of OLP acceptance or non-acceptance can be revealed as well as boundaries of differences within opinions. | one time assessment at baseline with a duration from max. 60 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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focus group discussions (FGD)