Protocol - Sickle Cell Disease Pain Associated with Menstruation - Quality of Life
- Frequency of Sickle Cell Pain Episodes Per Year
- Gender Identity
- Ovulation History
- Pain Intensity - Adolescent and Adult
Description
The modified version of the Sickle Cell Disease Pain Burden Interview–Youth (SCPBI-Y) is a 7-item, self-administered questionnaire to document the burden of sickle cell pain associated with the participant’s last menstrual period. Each item is scored on a five-point Likert scale (1 = None; 5 = Every) indicating the number of days impacted by sickle cell pain. The scores from each item can be summed to give a total score, with higher scores indicating higher pain burden and impact on quality of life.
Specific Instructions
Although validated in participants of ages up to and including 21 years, the Sickle Cell Disease Genitourinary Working Group (WG) recommends that the instrument can be used in older populations.
The WG notes some questions in this assessment are sensitive. 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).
Availability
Protocol
Modified version of the Sickle Cell Disease Pain Burden Interview-Youth (SCPBI-Y)
I want you to think about your sickle cell pain experienced 7 days before or during your last menstrual period:
- How many days have you had any sickle cell pain during this menstrual period?
[ ] 2 A Few
[ ] 3 Some
[ ] 4 Many
[ ] 5 Every
- How many nights have you slept poorly (trouble falling asleep or waking up during sleep) because of sickle cell pain during this menstrual period?
[ ] 2 A Few
[ ] 3 Some
[ ] 4 Many
[ ] 5 Every
- How many days have you had trouble taking care of yourself (dressing, going to the bathroom, showering) because of sickle cell pain during this menstrual period?
[ ] 2 A Few
[ ] 3 Some
[ ] 4 Many
[ ] 5 Every
- How many days have you missed from school/work because of sickle cell pain during this menstrual period?
[ ] 2 A Few
[ ] 3 Some
[ ] 4 Many
[ ] 5 Every
- How many days have you left school/work early because of sickle cell pain during this menstrual period?
[ ] 2 A Few
[ ] 3 Some
[ ] 4 Many
[ ] 5 Every
- How many days have you been unable to do things you enjoy because of sickle cell pain during this menstrual period?
[ ] 2 A Few
[ ] 3 Some
[ ] 4 Many
[ ] 5 Every
- How many days have you felt sad, mad, or upset because of sickle cell pain during this menstrual period?
[ ] 2 A Few
[ ] 3 Some
[ ] 4 Many
[ ] 5 Every
Scoring:
“None” = 0, “A Few” = 1, “Some” = 2, “Many” = 3, and “Every” = 4.
Scores range from 0 to 28; that is, no pain burden to severe pain burden.
Personnel and Training Required
None
Equipment Needs
None
Requirements
| Requirement Category | Required |
|---|---|
| Major equipment | No |
| Specialized training | No |
| Specialized requirements for biospecimen collection | No |
| Average time of greater than 15 minutes in an unaffected individual | No |
Mode of Administration
Self-administered questionnaire
Lifestage
Child, Adolescent, Adult
Participants
Menstruating participants with sickle cell disease that have had one or more menstrual periods.
Selection Rationale
This measurement protocol records the impact of sickle cell pain on daily living during menstruation and the impact of that pain. For participants with sickle cell disease, this information is important to understanding the overlap of menstrual-associated pain with acute “sickle cell” pain and its impact on quality of life. Use of one or more scales (e.g., measuring acute “sickle cell” pain and menstrual pain) may be most helpful in understanding this overlap.
Language
English
Standards
| Standard | Name | ID | Source |
|---|
Derived Variables
None
Process and Review
Not applicable.
Protocol Name from Source
Modified version of the Sickle Cell Disease Pain Burden Interview-Youth (SCPBI-Y)
Source
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
General References
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
Protocol ID
881101
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX881101_SCD_Pain_Menstruation_Quality_Of_Life_Days_During_Period | ||||
| PX881101010000 | How many days have you had any sickle cell more | N/A | ||
| PX881101_SCD_Pain_Menstruation_Quality_Of_Life_Days_Left_School_Work_Period | ||||
| PX881101050000 | How many days have you left school/work more | N/A | ||
| PX881101_SCD_Pain_Menstruation_Quality_Of_Life_Days_Missed_School_Work_Period | ||||
| PX881101040000 | How many days have you missed from more | N/A | ||
| PX881101_SCD_Pain_Menstruation_Quality_Of_Life_Days_Sad_Mad_Upset_Period | ||||
| PX881101070000 | How many days have you felt sad, mad, or more | N/A | ||
| PX881101_SCD_Pain_Menstruation_Quality_Of_Life_Days_Trouble_Care_Self_Period | ||||
| PX881101030000 | How many days have you had trouble taking more | N/A | ||
| PX881101_SCD_Pain_Menstruation_Quality_Of_Life_Days_Unable_Do_Things_Enjoy_Period | ||||
| PX881101060000 | How many days have you been unable to do more | N/A | ||
| PX881101_SCD_Pain_Menstruation_Quality_Of_Life_Nights_Slept_Poorly_Period | ||||
| PX881101020000 | How many nights have you slept poorly more | N/A | ||
Measure Name
Sickle Cell Disease Pain Associated with Menstruation - Quality of Life
Release Date
August 15, 2023
Definition
This is a measure of the impact of acute “sickle cell” pain associated with menstruation on mood, daily functioning, and quality of life.
Purpose
Acute “sickle cell” pain may 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 pain can impact activities of daily living as well as sleep, mood, and school/work and is associated with increased healthcare utilization.
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).
Keywords
dysmenorrhea, genitourinary, menstrual, menstruation, sickle cell disease, vaso-occlusive pain, women, period, sickle cell pain, pain
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 881101 | Sickle Cell Disease Pain Associated with Menstruation - Quality of Life |
Publications
There are no publications listed for this protocol.