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Follow-up Assessment of a Trial of Open-label Placebos for Women With Premenstrual Syndrome

Recruiting
years of age
Female
Phase N/A

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Overview

With the proposed study, the investigators aim to evaluate the long-term efficacy of the open-label placebo (OLP) intervention in premenstrual syndrome (PMS) and to contribute to a broader understanding of how OLPs work. It is planned to survey participants of the intervention groups (OLP+ and OLP-) regarding symptom intensity and impairment due to PMS after the conclusion of our randomized controlled trial (RCT) and intervention provision. Additionally, it will be examined if there is a difference between the OLP group with and without a treatment rationale (OPL+ vs. OLP-) across time. More precisely, it will be investigated whether participants of the intervention groups with and without treatment rationale experience any long-term improvement.

Eligibility

Inclusion Criteria:

  • Participants are willing to participate in the follow-up study
  • Participants have the ability to use an electronic device with internet access to complete the online follow-up survey
  • Participants give Informed consent
  • Participants have a regular menstruation (i.e., no menopause; pregnancy; cycle inhibiting medication etc.)

Exclusion Criteria:

  • Pregnancy or breastfeeding (currently or within the last three months)
  • A severe psychological or somatic disease, affecting premenstrual complaints (e.g., cancer of the uterus or fallopian tubes)
  • Commencement of the menopause, sterilization, or (part) resection of the uterus or fallopian tubes
  • Changes in body mass index (i.e., under 18 or above 30)

Study details

Premenstrual Syndrome

NCT06206460

University Hospital, Basel, Switzerland

14 February 2024

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