Premenstrual Syndrome
Conditions
Keywords
Premenstrual Syndrome, Open-label Placebo, RCT follow up
Brief summary
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.
Interventions
OTHEROnline Assessment
Online Assessment which consists of: * Sociodemographic data (life changes, medical and gynaecological history) * German PMS symptom diary retrospectively for last menstrual cycle * Quality of Life Inventory (SF-12) * Expectancy of relief
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom intensity of premenstrual syndrome | One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase) | The items of the German PMS \[Premenstrual Syndrome\] Symptom diary will be used to measure symptom intensity retrospectively for the last luteal phase ( i.e., PMS phase). The scale consists of 27 items measured on a 6-point Likert scale. A decrease in scores indicates an improvement in symptom intensity. The minimum score is zero; the maximum 162. |
| Interference of premenstrual syndrome | One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase) | The items of the German PMS \[Premenstrual Syndrome\] Symptom diary will be used to measure interference retrospectively for the last luteal phase ( i.e., PMS phase). The scale consists of 3 items measured on a 6-point Likert scale. A decrease in scores indicates an improvement in interference. The minimum score is zero; the maximum 162. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (Short-Form-12) | One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase) | Quality of life will be measured by means of the SF-12 (Short-Form-12) questionnaire retrospectively for the last luteal phase (i.e., PMS phase). The questionnaire comprises 12 questions, and quality of life is measured on a 6-point Likert scale. Two summary scores can be calculated: a mental component and a physical component score. Scores range from 0-100, with higher scores indicating better functioning. |
| Partnership satisfaction (Zufriedenheit in der Partnerschaft: ZIP) | One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase) | Partnership satisfaction will be measured by means of the ZIP (Zufriedenheit in der Partnerschaft) questionnaire retrospectively for the last luteal phase (i.e., PMS phase). The questionnaire comprises 7 questions, and partnership satisfaction is measured on a 5-point rating scale. Scores range from 7 to 35. |
Countries
Switzerland
Outcome results
None listed