CRAMP Study

According to recent studies, menstrual pain and stress have been increasing in recent years. In order to address this growing issue, we first need to understand how menstrual pain and stress are related.

Can I enroll?

To be eligible to participate in this study, an individual must meet all of the following criteria:

Between the ages of 18 and 40
Have regular menstrual cycles every 21 to 40 days
Are not currently taking, or have not taken, hormonal contraceptives (e.g. the pill) within the past three months
Are not pregnant or lactating
Have not had surgery in the last 3 months
Are not currently ill
Own an Apple iPhone
Can read English

Learn how the CRAMP Study works

Your menstrual cycle is a part of a bigger picture

The menstrual cycle is a part of life for many people. It reacts to the complex intertwining of many processes of both body and mind. But menstruation is often characterized by pain and stress, which can affect their daily lives, limiting people’s ability to complete everyday tasks. The rise of both menstrual pain and stress is particularly concerning. And we need to do something about it, together.

The first step is to understand the mechanisms behind both stress and menstrual pain.

To understand these mechanisms, we need to collect data from people who menstruate. This knowledge is achieved by analyzing individual experiences to understand what they have in common. Unfortunately, menstrual pain, and menstruation in general, is an under-researched topic. This is something this study is hoping to change with your help.

Join this study, share your menstrual experience with an easy daily survey and help us better understand menstrual pain.

The Science behind the CRAMP Study

Menstruation-related symptoms are widespread among women, with prevalence of menstruation-related pain ranging from 15% to 91% (1). The impact of menstruation-related symptoms on patient’s life and health are significant, with the degree of menstruation-related symptoms being associated with lower scores on several quality-of-life domains (2), including physical, mental and social functioning. Menstruation-related symptoms are also associated with a decrease both in productivity and hours worked, resulting in financial burden for both the patients and the society as a whole (3).

Studies have shown that the intensity of menstruation-related pain is associated with increased perceived stress (1). On the other hand, resilience to stress is inversely associated with subjective stress and pain intensity both in standardized controlled pain induction experiments (4) and in observational studies involving chronic pelvic pain patients (5). However, no study has assessed this association for menstruation-related pain intensity. We therefore believe that a study thoroughly assessing the association between stress, stress resilience and menstruation-related symptoms, and in particular pain, is still needed. Moreover, previous studies are limited by the fact that stress resilience was measured using different types of scales (6), which are confounded by recall-bias and social desirability. In our study, we will utilize a digital stress test (7) to induce a stress reaction and accurately measure stress responses to build new reliable direct measurements of stress resilience. This will enable a more precise characterization of the association between stress resilience and pain perception.

References

1. Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea (eng). Epidemiologic reviews 2014;36:104–13.

2. Unsal A, Ayranci U, Tozun M, Arslan G, Calik E. Prevalence of dysmenorrhea and its effect on quality of life among a group of female university students (eng). Upsala Journal of Medical Sciences 2010;115(2):138–45.

3. Schoep ME, Adang EMM, Maas JWM, Bie B de, Aarts JWM, Nieboer TE. Productivity loss due to menstruation-related symptoms: a nationwide cross-sectional survey among 32 748 women (eng). BMJ open 2019;9(6):e026186.

4. Friborg O, Hjemdal O, Rosenvinge JH, Martinussen M, Aslaksen PM, Flaten MA. Resilience as a moderator of pain and stress (eng). Journal of psychosomatic research 2006;61(2):213–9.

5. Giannantoni A, Gubbiotti M, Balzarro M, Rubilotta E. Resilience in the face of pelvic pain: A pilot study in males and females affected by urologic chronic pelvic pain (eng). Neurourology and urodynamics 2021;40(4):1011–20.

6. Windle G, Bennett KM, Noyes J. A methodological review of resilience measurement scales (eng). Health and quality of life outcomes 2011;9:8.

7. Norden M, Hofmann AG, Meier M, Balzer F, Wolf OT, Böttinger E et al. Inducing and Recording Acute Stress Responses on a Large Scale With the Digital Stress Test (DST): Development and Evaluation Study (eng). Journal of medical Internet research 2022;24(7):e32280.

What type of data do we collect and why

Your privacy and protection is our priority

Your data will be stored in an anonymized way in our server. All the data we will collect from you will be stored in secure HIPAA compliant servers. Only the researchers approved by our Institutional Review Board will be able to access the data we collect, and only to perform relevant analyses.

Baseline questionnaires

The following are questionnaires that CRAMP Study participants can answer as part of the study.

Demographic/socioeconomical questionnaire:

Health and disease are not only about biology. Social and economicfactors can play a big role in your health. We want to account for this in our analyses and assess the impact of socioeconomical factors in the development of menstrual cramps. We will therefore ask you several questions about your socioeconomicbackground, such as your zip code and your employment status, as well as your racial and ethnic background.

General health questionnaire:

Menstruation is a complex process involving several bodily systems. It is therefore not surprising that pre-existing health conditions influence menstruation and menstrual cramps. We will ask you several questions regarding your general health. We will also ask you to share your Apple Health app data with us. This will enable us to account for pre-existing health conditions in our analyses. Doing so will ensure that we can look at menstrual cramps-specific processes rather than other disorders that might influence your cramps.

Menstrual health questionnaire:

The CRAMP study is synchronized to your menstrual cycle. We will therefore ask you several questions regarding your usual menstrual pattern. Answering this survey will enable us to ask you the right questions at the right time. Moreover, menstruation is not only bleeding. The menstrual cycle is a complex cyclical process, with hormones fluctuating and influencing several systems in our bodies. It is commonto experience symptoms right before menstruation, sometimes so debilitating that they are described as premenstrual syndrome. This condition has been linked to more severe stress and menstrual cramps. We will therefore also ask you to complete a questionnaire that has been developed specifically to assess premenstrual symptoms. Answering these questions will enable us to take into account these factors when we characterize stress and menstrual pain.

Menstrual pain questionnaire:

The CRAMP study is all about menstrual pain. We will ask you questions regarding your menstrual pain throughout the study. But we can’t make sure that what you will report during the study will be what your usual experience is. We therefore designed this survey to collect information regarding your usual experience with menstrual pain. We don’t only want to know how intense the pain is, but also how you experience the pain. We will therefore include two sets of questions: one regarding your thoughts and feelings during pain, and the other one regarding how your daily activities are affected by your pain. Answering these questions will help us characterize pain beyond a mere score on a piece of paper and unravel its complexity

Sexual activity and pregnancy questionnaire

Menstruation is part of the reproductive cycle. We will therefore ask you several questions regarding your sexual activity and pregnancy history. These will enable us to understand the relationship between these factors and your experience with menstrual pain. We know this information is very private, and you might be concerned about answering some of these questions, especially after the recent Supreme Court ruling. We therefore requested a certificate of confidentiality to the National Institute of Health (NIH). This will prohibit anyone from requesting access to the information you share with us — not even tlaw enforcement.

Resilience to stressful situation questionnaire

The CRAMP study aims at characterizing the relationship between resilience to stress and menstrual pain. Resilience is the ability to bounce back from a stressful situation. We will ask you to answer a questionnaire that assesses your level of resilience. Together with the daily stress assessments and the digital resilience test, these answers will give us insight in the relationship between pain and stress.

Personality questionnaire

Stress and pain are both physical conditions that, have a big emotional component. We usually feel emotions as a reaction to an external event, such as receiving a bad news or winning a game. As with any kind of emotion, different personalities tend to react differently to the same situation. To account for this difference in our analyses, we will ask you to complete a personality questionnaire so that we can determine yours.

Social interaction and related questionnaires

Having tight social bonds and a network of people that support you through hard times can be a big help. The secondary aim of the CRAMP Study is to investigate if social interactions mediate the relationship between resilience and menstrual cramps. We will therefore ask you to fill out three questionnaires to assess your experiences of loneliness, social exclusion and your social bonds. These, together with the rest of the data we will collect on digital social interactions, will enable us to have test how much social bonds influence menstrual cramps and stress.

Lifetime cummulative stress exposure

Stress and its effects can accumulate over time and influence the resilience and reactions to new stressful situations. This is why in the CRAMP study, we will ask you to answer a few brief questions about stressful past events that might influence how you behave and perceive things today. This information will ultimately enable us to not only understand the short-term, but also the long-term effects of stress on menstrual pain intensity.

Timed questionnaires

These questionnaires are time-dependent. CRAMP Study participants will be asked to answer at a specific time. It is very important that participants give these questions priority whenever they do not have enough time to complete also other available questionnaires.

Daily questionnaires and Ecologic Momentary Assessments

In the CRAMP Study, we want to closely characterize the relationship between stress, resilience and menstrual cramps and symptoms. Since stress and pain usually come and go, it is of utmost importance that we assess how those factors change not only day by day, but also throughout the day. Ultimately, this will enable us to look for temporal patterns of pain, stress and their relationship and unlock these complex interactions. We will therefore ask you to complete a brief daily questionnaire to tell us how your day was. Moreover, we will ask you to answer 3 very short questions — 3 times a day. This is called a ecologic momentary assessment, because we want to know how you are feeling exactly in that moment. Answering these momentary assessments will enable us to have a more precise picture of how stress and pain change.

Mood, stress and symptoms

The day before the digital resilience test as well as one week after the start of you menstruation, we will ask you to answer some questions regarding your mood, stress and presence of symptoms. This questionnaire will ask you to think about the past week. We want to use your answers to compare how your mood, stress and symptoms change from a week with and without menstruation. It is important that you answer the questionnaire the day we unlock this task so that we can compare different menstrual phases.

Digital Resilience Test

The CRAMP Study was designed to leverage new digital health methods and technologies to characterize stress, resilience and menstrual cramps. A central component of the study will be the Digital Resilience Test. This test was developed to be performed entirely on your smartphone through our ehive study application. The test consists in two cognitive tasks. We will ask you a couple of questions before and after the test to assess your mood, feelings, and stress levels. We will also ask you to use your Apple Watch Breathing app before and after the test, so that we can measure your heart beats very accurately. The digital resilience test will be used to built objective measures of resilience, ultimately enabling the characterization resilience and menstrual pain.

Passive Data Collection

Smartphone Data and Data Donation

Beyond the questionnaires, we will ask you to share with us anonymous data about your virtual social interactions. We will use both data stored in your iPhone, as well as ask you to use our data donation platform to share Facebook Messenger and WhatsApp data. We will never be able to read the content of your messages or any information regarding whom you interacted with.

Apple Watch Data

We will ask you to wear your Apple Watch for as much time as possible during the CRAMP Study. We will collect information regarding your physical activity, sleep, heart rate and oxygen levels. All these variables interact with and associate with different stress and pain levels. Using the Apple Watch data, we want to objectively assess your stress and pain and better characterize their relationship.