Clinical trial NCT05166213: Patients' Attitudes Towards Open-Label Placebo Implementation Into Clinical Practice
Official title: Patients' Attitudes Towards Open-Label Placebo Implementation Into Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open-label Placebos
Keywords: focus group discussions (FGD)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited with help of physicians from the following clinics:

University Hospital Basel Anästhesiologie: Schmerzmedizin Frauenklinik: Gynäkologische Sozialmedizin und Psychosomatik Neurologie: Migräne und Morbus Parkinson Sprechstunden Onkologie und Psychoonkologie Privatklinik Hohenegg AG. Interested patients will receive a flyer of the study and will be asked if they prefer to enter in contact with the study team by themselves or if the study team is allowed to call the patient.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Qualitative data analysis
timeFrame: one time assessment at baseline with a duration from max. 60 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
Study officials:
affiliation: University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
name: Antje Frey Nascimento, Dr.
role: PRINCIPAL_INVESTIGATOR
References: