Protocol - Sickle Cell Disease Pain Associated with Menstruation
This protocol includes five self-administered items from the Demographic Survey in Table 1 from Sharma et al. (2019) that document sickle cell pain associated with menstruation. The protocol includes instructions for categorizing participants who experience acute “sickle cell” pain that is temporally associated with menstrual pain.
The Sickle Cell Disease Genitourinary Working Group (WG) notes the sensitive nature of some questions in this assessment. Investigators should provide a private space for completing assessments and to be prepared to offer appropriate support.
The WG strongly recommends investigators collect both Sickle Cell Disease Pain Associated with Menstruation and Sickle Cell Disease Pain Associated with Menstruation - Quality of Life to fully assess the impact of menstruation on sickle cell pain. Additionally, the WG recommends that investigators follow the scoring criteria to distinguish sickle cell pain and menstrual pain described in Table 1 of Sharma et al. (2019).
The WG notes that the overlap of menstrual pain and sickle cell pain is not well understood and encourages investigators to develop and validate new tools to better distinguish these types of pain and also to define experiences of affected people.
Questions Regarding SCD Pain Associated with Menstruation, excerpted from Demographic Survey from Table 1 in Sharma et al. (2019).
The Sickle Cell Disease Genitourinary Working Group notes the term “pain” in the questions below refers to specifically to “sickle cell pain.”
1. Have you been able to identify any triggers for your pain?
[ ] 1 Yes
[ ] 2 No
2. If you answered yes to question 1, what triggers your pain? (Circle all that apply)
[ ] 1 Cold weather
[ ] 2 Seasons changing
[ ] 3 Dehydration in the summer time
[ ] 4 Exercise
[ ] 5 Menstrual periods
[ ] 6 Stress
[ ] 7 Illness
[ ] 8 Other: ___________
[ ] 9 Not applicable
3. Have you ever experienced “sickle cell pain” in the week before or during your period?
[ ] 1 Yes
[ ] 2 No
4. If you answered “Yes” to the question above (question 3), when you think of your last menstrual period, when did you start to have “Sickle cell pain”? If no, please skip this question.
[ ] 1 0-7 days before the start of your menstrual period
[ ] 2 During your menstrual period
[ ] 3 0-7 days after your menstrual period
[ ] 4 I did not have sickle cell pain associated with my menstrual period
[ ] 5 Not applicable
5. If you answer “Yes” to question 3 above, how often do you have your “sickle cell pain” during your periods?
If no, please skip this question.
[ ] 1 Every now and then
[ ] 2 Almost every period
[ ] 3 With every period
[ ] 4 Not applicable
Acute “sickle cell” pain associated with menstruation is defined as a “Yes” answer to all of the following:
Do your menstrual periods trigger your “sickle cell pain”
- Answers “Yes” to question 1 and
- Selects “Menstrual periods” in question 2.
Do you start to have “sickle cell pain” 0-7 days before or during your periods?
- Answers “Yes” to question 3 and
- Selects “0-7 days before the start of your menstrual period” or “During your menstrual period” in question 4.
Does your “sickle cell pain” occur with either every or almost every menstrual period?
- Selects “Almost every period” or “With every period” for question 5.
Personnel and Training Required
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Adolescent and adult menstruating participants with sickle cell disease
This measurement protocol records the incidence of sickle cell pain during menstruation, separately from menstrual pain. This information is important to understanding the overlap of menstrual-associated pain with “sickle cell” pain. Use of one or more scales (e.g., measuring acute “sickle cell” pain and menstrual pain) may be useful in understanding this overlap.
Process and Review
Protocol Name from Source
Sharma et al. Acute vaso-occlusive pain is temporally associated with the onset of menstruation in women with sickle cell disease. J Women’s Health (Larchmt), 2019. Demographic survey.
Sharma, D., Day, M. E., Stimpson, S.-J., Rodeghier, M., Ghafuri, D., Callaghan, M., Zaidi, A. U., Hannan, B., Kassim, A., Zempsky, W., Wellons, M., James, A., Bruehl, S., & DeBaun, M. R. (2019). Acute vaso-occlusive pain is temporally associated with the onset of menstruation in women with sickle cell disease. Journal of Women’s Health, 28(2), 162-169. https://doi.org/10.1089/jwh.2018.7147
This protocol includes questions 11 and 12 from section 1 and questions 10-12 from section 2 of the demographic survey.
Chesney, M. A., & Tasto, D. L. (1975). The development of the menstrual symptom questionnaire. Behaviour Research and Therapy, 13(4), 237-244. https://doi.org/10.1016/0005-7967(75)90028-5
Day, M., Bonnet, K., Schlundt, D. G., DeBaun, M., & Sharma, D. (2020). Vaso-occlusive pain and menstruation in sickle cell disease: A focus group analysis. Women’s Health Reports,1(1), 36-46. https://doi.org/10.1089/whr.2019.0008
Zempsky, W. T., O'Hara, E. A., Santanelli, J. P., Palermo, T. M., New, T., Smith-Whitley, K., & Casella, J. F. (2013). Validation of the sickle cell disease pain burden interview–Youth. Journal of Pain, 14, 975-982. https://doi.org/10.1016/j.jpain.2013.03.007
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX881001030000||Have you ever experienced "sickle cell pain" more||N/A|
|PX881001050000||If you answer "Yes" to question 3 above, how more||N/A|
|PX881001040000||If you answered 'Yes' to the question above more||N/A|
|PX881001010000||Have you been able to identify any triggers more||N/A|
|PX881001020000||If you answered yes to question 1, what more||N/A|
|PX881001020100||If you answered yes to question 1, what more||N/A|
Sickle Cell Disease Pain Associated with Menstruation
August 15, 2023
This is a measure of menstrual-associated pain in females with sickle cell disease.
Acute sickle cell pain episodes are associated with increased health care utilization, morbidity, and mortality. Acute sickle cell pain can be temporally associated with menstruation in participants with sickle cell disease, and the overlap between menstrual pain and sickle cell pain can be difficult to assess. This protocol can be useful in understanding this relationship between acute sickle cell pain and menstruation.
The Sickle Cell Disease Genitourinary Working Group (WG) strongly recommends investigators collect both Sickle Cell Disease Pain Associated with Menstruation and Sickle Cell Disease Pain Associated with Menstruation - Quality of Life to fully assess the impact of menstruation on sickle cell pain. Additionally, the WG recommends that investigators follow the scoring criteria to distinguish sickle cell pain and menstrual pain described in Table 1 of Sharma et al. (2019).
sickle cell disease pain associated with menstruation, dysmenorrhea, genitourinary, menstrual, menstruation, sickle cell disease, vaso-occlusive pain, women, period, sickle cell pain, pain
|Protocol ID||Protocol Name|
|881001||Sickle Cell Disease Pain Associated with Menstruation|
There are no publications listed for this protocol.