Menstrual Pain Intervention Among Students
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Potsdam
About this trial
Dysmenorrhea, or menstrual pain, is a prevalent issue among female students, which negatively influences students' productivity, academic performance, and quality of life.
This study explores a non-pharmaceutical physiotherapy method that has shown potential to decrease menstrual cramping, but research on its efficacy remains limited. The intervention is a visceral abdominal self-massage.
Because individuals tend to respond differently to physiotherapy methods, the investigators aim to assess the effect of performing the self-massage regularly on the self-reported perception of menstrual pain and related symptoms of female students in Germany, with a series of N-of-1 trials.
N-of-1 trials lasting up to 60 days are conducted with participants who regularly experience dysmenorrhea. Participants undergo a control (A) and an intervention phase (B), with a probable second control phase (A) depending on the individual cycle lengths and study start. Daily symptoms are recorded via the StudyU smartphone application. The baseline questionnaire collects demographic, lifestyle, and menstrual history information to identify potential effect modifiers. The intervention's effects will be estimated across individual and population levels. Participants will receive access to an analysis of their data.
The results may benefit individual well-being and contribute to the exploration of a more holistic approach to menstrual health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female students living in Germany
Have consistently experienced menstrual pain and other symptoms primarily during menstruation for at least the last three cycles
Regular access to a smartphone on which the StudyU (https://www.studyu.health/) application can be installed
Informed consent
Disqualifiers
Age under 18 or over 45 years
Participation in a different intervention study during the duration of this study
Use of hormonal treatments affecting the menstrual cycle
Confirmed or suspected pregnancy
Trial design
Design model
Crossover
Treatments tested in this trial
Abdominal Self-Massage
BehavioralDaily self-administered visceral abdominal massage consisting of circular motions and pressure point techniques, performed for 5-20 minutes in total based on participant preference. The massage includes two parts: belly exercises (10 exercises) and pelvic exercises (3 exercises), with each exercise repeated 5-10 times or until the area feels relaxed. The app provides instructional videos and written step-by-step guides with drawings in English and German. Participants are recommended to use oil/cream, find a comfortable position, and integrate the massage into a daily routine.
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: Abdominal Self-MassageExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Daily Perceived Menstrual Pain
Participants assess the severity of menstrual pain on a visual analog scale from 0 to 10 (0=no pain, 10=worst pain imaginable).
Time frame
Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 daysSecondary outcomes
1
Pain Medication Intake
Participants select which pain medication was used (if any) from a predefined list including: acetylsalicylic acid (Aspirin), butylscopolamine (Buscopan), butylscopolamine + paracetamol combinations, diclofenac (Voltaren), ibuprofen (Nurofen, Dolormin Extra), metamizole (Novalgin), naproxen (Dolormin for Women), paracetamol (Benuron), or other medications. Participants also report the number of tablets taken.
Time frame
Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days2
Additional Menstrual Symptoms
Participants indicate if any of the following additional symptoms are experienced (Yes/No for each): * Cramps * Lower back pain * Nausea, vomiting, or diarrhea * Painful urination * Dyschezia * Abdominal bloating * Painful intercourse * Fatigue or difficulty concentrating * Fainting * Headaches
Time frame
Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days3
Mood Impact
Participants rate how symptoms affected mood on a scale from 0 (no impact at all) to 4 (very strongly negatively).
Time frame
Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days4
Symptom Narrative
Participants provide a daily free-text narrative describing their overall well-being, symptoms, and physical and emotional state.
Time frame
Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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