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

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University Hospital Basel

Status

Completed

Conditions

Open-label Placebos

Treatments

Other: focus group discussions (FGD)

Study type

Observational

Funder types

Other

Identifiers

NCT05166213
2021-02304 ex21Frey;

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

6 participants in 5 patient groups

Chronic back pain
Treatment:
Other: focus group discussions (FGD)
Clinically significant menopausal complaints
Treatment:
Other: focus group discussions (FGD)
Parkinson's disease
Treatment:
Other: focus group discussions (FGD)
Migraine
Treatment:
Other: focus group discussions (FGD)
Cancer-related emesis/nausea
Treatment:
Other: focus group discussions (FGD)

Trial contacts and locations

1

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Central trial contact

Antje Frey Nascimento, Dr.

Data sourced from clinicaltrials.gov

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