Follow-up Assessment of the Randomized Controlled Trial: Open-label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Symptom intensity of premenstrual syndrome
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •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)
结局指标
主要结局
Symptom intensity of premenstrual syndrome
时间窗: 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
时间窗: 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.
次要结局
- 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))
- 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))