Cramps, Dysmenorrhea, Dysmenorrhea Primary, Menstrual Cycle Abnormal, Menstrual Discomfort, Menstrual Pain, Menstrual Problem, Ovarian Cysts, PCOS, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, PCOS (Polycystic Ovary Syndrome) of Left Ovary, PCOS (Polycystic Ovary Syndrome) of Right Ovary, Period Pain, Period Problem, PMS, Polycystic Ovary Syndrome, Premenstrual Dysphoric Disorder, Premenstrual Syndrome
Conditions
Keywords
Dysmenorrhea, Primary Dysmenorrhea, Menstrual Discomfort, Menstrual Pain, Menstrual Problem, Menstrual Cycle Abnormal, Period Pain, Period Problem, PMS, Premenstrual Syndrome, PCOS, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, PCOS (Polycystic Ovary Syndrome) of Left Ovary, PCOS (Polycystic Ovary Syndrome) of Right Ovary, Polycystic Ovary Syndrome, Premenstrual Dysphoric Disorder, Cramps, Ovarian Cysts
Brief summary
85 percent of women of reproductive age experience consistent period cramps/menstrual pain, and 60% indicate that they do not use painkillers to relieve menstrual symptoms; there is a need for natural and non-medicative supplements to dysmenorrhea. The purpose of this clinical trial is to examine the effect of 'Cramp Bites'--classified by a mixture of natural ingredients researched to help with period pain--on women suffering from primary dysmenorrhea: this will be done through providing participants with the snack and surveying them on how it changes their period symptoms.
Detailed description
Participants will be asked the following information at the interview: name, month and year of birth, ethnicity, email, and phone number. As well, they will be prompted for their lifestyle habits, allergies, prior pregnancies and deliveries, presence of pathological disorders, medication (specifically asking about oral contraception), use of over-the-counter painkillers for period cramps/menstrual pain, expected date of next period, and menstrual cycle history. They will also be asked to complete the Menstrual Symptom Questionnaire. The baseline questionnaire will ask the participant about their prior experience with primary dysmenorrhea symptoms and with period cramps/menstrual pain on a sliding scale. The daily questionnaire will ask the participant to rate the extent of their period cramps/menstrual pain, to describe their pain, and whether they have taken any drugs for their period pain on that day. This questionnaire will be completed by all participants starting 2 days before their next onset of menstruation. Participants were randomly assigned Cramp Bites or the Placebo Snack: all other protocols remain the same. After their next menstrual cycle ends, participants will be asked to fill out a final questionnaire: this questionnaire will ask the participant if they have noticed any changes in their period pain, the efficacy of the snack, and if they have suggestions/comments about the snack. This study is divided into 4 parts. Some parts will take place at Cornell University, and other parts can be completed online.
Interventions
DIETARY_SUPPLEMENTCramp Bites by Aunt Flo's Kitchen
Participants who are randomly assigned this snack are instructed to eat one serving each day, starting 2 days before their next onset of menstruation, and extending 3 days into their menstrual cycle. They are instructed to eat their assigned snack each time they experience menstrual cramps, whether spasmodic or congestive.
Sponsors
Cornell University
Laidlaw Foundation
Epperson Fund
Beck Fellowship
Dan Cane Fund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants are randomly assigned either 'Cramp Bites' or our Placebo Snack over the duration of one menstrual cycle.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Women between the ages of 18 and 25 who experience primary dysmenorrhea and have no pathological disorders.
Exclusion criteria
* Pregnancy or breast feeding within 6 months * Primary or secondary amenorrhea * Body mass index less than the 1st percentile or body weight above 300 lbs * Undergoing menstrual suppression by medicative means * Unwilling to avoid painkillers (ibuprofen or naproxen) for the duration of the study unless absolutely necessary * Has allergies or aversions to ingredients used in either Cramp Bites or the Placebo Snack * Not fluent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for Spasmodic Cramps | Participants complete this survey when they experience cramps: once before they consume their snack, and once after. Completion time for each survey is 7 minutes. | Participants rate their spasmodic cramp severity before and after eating either Cramp Bites or the Placebo Snack using the Visual Analogue Scale. This is on a scale from 0 to 10, where 0 represents no cramps and 10 indicates extreme abdominal cramping. |
| Visual Analogue Scale for Congestive Cramps | Participants complete this survey when they experience cramps: once before they consume their snack, and once after. Completion time for each survey is 7 minutes. | Participants rate their congestive cramp severity before and after eating either Cramp Bites or the Placebo Snack using the Visual Analogue Scale. This is on a scale from 0 to 10, where 0 represents no cramps and 10 indicates extreme abdominal cramping. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual Symptom Questionnaire (MSQ) | Participants complete this questionnaire with a researcher before the study. Time to complete this questionnaire is 15 minutes. | Filled out during intake exam. MSQ indicates to what extent the participant suffers from spasmodic cramps, congestive cramps, or a mixture of the two. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Product Feedback Form | Participants were asked to fill out this survey at the end of the study. Completion time was 5 minutes. | Participants are asked to fill out a feedback form indicating how confident they were about their assigned snack's efficacy and the taste of the snack. |
Countries
United States
Outcome results
None listed