Evaluation of Easy-to-Implement Intervention for Menstrual Pain in a Series of N-of-1 Trials: Study Protocol of the Menstrual Pain Intervention Among Students Study (MPIS)

BackgroundDysmenorrhea, or menstrual pain, is a prevalent issue among female university students that negatively influences their productivity, academic performance, and quality of life. Because the conventional treatments, such as non-steroidal anti-inflammatory drugs and hormonal contraceptives, often lead to undesirable side effects, there is a need for alternative, non-pharmaceutical methods. Abdominal self-massage has been shown potential to decrease menstrual cramping, but the research on its efficacy remains limited. Individuals respond differently to physiotherapy interventions. Therefore, we aim to assess the effect of performing an abdominal self-massage regularly on the self-reported perception of menstrual pain and related symptoms of female university students in Germany, with a series of N-of-1 trials. MethodsA non-randomized, unblinded N-of-1 trial is carried out over 60 days among participants who regularly experience dysmenorrhea. Participants start at different times of their menstrual cycle in a control phase (A) followed by an intervention phase (B) and a possible second control phase (A) depending on the individual cycle length and study start. Daily symptoms are recorded via the StudyU smartphone application. A baseline survey collects demographic, lifestyle and menstrual history information to identify potential effect modifiers. Bayesian multi-level modeling will be used to estimate the interventions effects on the individual and population level. Free text descriptions will be analyzed exploratively with a large language model-based natural language processing pipeline. DiscussionThis study investigates abdominal massage as a potential self-care practice for managing menstrual symptoms. The results may benefit the individual well-being and contribute to the exploration of a more holistic approach to menstrual health. Trial RegistrationClinicalTrials.gov NCT07155291