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

University Hospital Basel

Status

Enrolling

Conditions

Premenstrual Syndrome

Treatments

Other: Online Assessment

Study type

Observational

Funder types

Other

Identifiers

NCT06206460

2023-02187 ub24Frey;

Details and patient eligibility

About

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.

Enrollment

95 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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)