Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to determine the Minimal Clinically Important Difference (MCID) for the Visual Analog Scale (VAS), Menstrual Symptom Questionnaire (MSQ), and Functional and Emotional Measure of Dysmenorrhea (FEMD) in patients with primary dysmenorrhea (PwPD).
100 PwPD will receive functional exercises three times a week for three menstrual cycles. Patients will be assessed on the most painful days of the first (baseline), second, and third menstrual cycles. The receiver operating characteristics (ROC) method and Gamma coefficient analysis will be applied to determine the responsiveness.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Treatment | Experimental | Each patient will receive a treatment protocol consisting of warm-up and functional exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Treatment | Other | In this study, a functional exercise programme will be performed 3 days a week for 8 weeks in three cycles as previously recommended. This programme consisted of a 5-minute warm-up and a 45-minute exercise phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky). | Baseline (On the most painful day of the menstrual cycle before the intervention) |
| Pain Intensity | Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky). | After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention) |
| Pain Intensity | Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky). | After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual Symptom Questionnaire (MSQ) | The Likert scale consists of 22 items, with responses rated on a 5-point range from 1 (never) to 5 (always). The scale includes three components: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The MSQ score is the mean value of all items in the scale. Increasing scores reflect more menstrual symptoms. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Only women with primary dysmenorrhea will be included.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zeynep Yıldız Kızkın, Dr. | Artvin Coruh University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeynep Yıldız Kızkın | Artvin | 08000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26328887 | Background | Habibi N, Huang MS, Gan WY, Zulida R, Safavi SM. Prevalence of Primary Dysmenorrhea and Factors Associated with Its Intensity Among Undergraduate Students: A Cross-Sectional Study. Pain Manag Nurs. 2015 Dec;16(6):855-61. doi: 10.1016/j.pmn.2015.07.001. Epub 2015 Aug 29. | |
| 35249825 | Background | Guy M, Foucher C, Juhel C, Rigaudier F, Mayeux G, Levesque A. Transcutaneous electrical neurostimulation relieves primary dysmenorrhea: A randomized, double-blind clinical study versus placebo. Prog Urol. 2022 Jul;32(7):487-497. doi: 10.1016/j.purol.2022.01.005. Epub 2022 Mar 3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
Not provided
Not provided
In this prospective study, one treatment group was formed to receive exercise treatment.
Not provided
Not provided
Not provided
Not provided
| Baseline (On the most painful day of the menstrual cycle before the intervention) |
| Menstrual Symptom Questionnaire (MSQ) | The Likert scale consists of 22 items, with responses rated on a 5-point range from 1 (never) to 5 (always). The scale includes three components: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The MSQ score is the mean value of all items in the scale. Increasing scores reflect more menstrual symptoms. | After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention) |
| Menstrual Symptom Questionnaire (MSQ) | The Likert scale consists of 22 items, with responses rated on a 5-point range from 1 (never) to 5 (always). The scale includes three components: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The MSQ score is the mean value of all items in the scale. Increasing scores reflect more menstrual symptoms. | After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention) |
| Functional and Emotional Measure of Dysmenorrhea (FEMD) | The FEMD is a 14-item measurement tool that evaluates the functional and emotional aspects of dysmenorrhea using a 5-point Likert-type scale. The total scores on this scale range from 14 to 70, with higher scores indicating a more significant functional and emotional impact of dysmenorrhea on an individual. | Baseline (On the most painful day of the menstrual cycle before the intervention) |
| Functional and Emotional Measure of Dysmenorrhea (FEMD) | The FEMD is a 14-item measurement tool that evaluates the functional and emotional aspects of dysmenorrhea using a 5-point Likert-type scale. The total scores on this scale range from 14 to 70, with higher scores indicating a more significant functional and emotional impact of dysmenorrhea on an individual. | After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention) |
| Functional and Emotional Measure of Dysmenorrhea (FEMD) | The FEMD is a 14-item measurement tool that evaluates the functional and emotional aspects of dysmenorrhea using a 5-point Likert-type scale. The total scores on this scale range from 14 to 70, with higher scores indicating a more significant functional and emotional impact of dysmenorrhea on an individual. | After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention) |
| Global Rating Change (GRC) | The GRC comprised seven responses, ranging from 1 to 7, indicating "very much better," "much better," "slightly better," "no change," "slightly worse," "much worse," and "very much worse," respectively. | After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention) |
| Global Rating Change (GRC) | The GRC comprised seven responses, ranging from 1 to 7, indicating "very much better," "much better," "slightly better," "no change," "slightly worse," "much worse," and "very much worse," respectively. | After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention) |
| 1238078 | Background | Chesney MA, Tasto DL. The development of the menstrual symptom questionnaire. Behav Res Ther. 1975 Oct;13(4):237-44. doi: 10.1016/0005-7967(75)90028-5. No abstract available. |
| 22242651 | Background | Li L, Huangfu L, Chai H, He W, Song H, Zou X, Wang W. Development of a functional and emotional measure of dysmenorrhea (FEMD) in Chinese university women. Health Care Women Int. 2012;33(2):97-108. doi: 10.1080/07399332.2011.603863. |
| 10812317 | Background | Husted JA, Cook RJ, Farewell VT, Gladman DD. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol. 2000 May;53(5):459-68. doi: 10.1016/s0895-4356(99)00206-1. |
| 28625286 | Background | Burnett M, Lemyre M. No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017 Jul;39(7):585-595. doi: 10.1016/j.jogc.2016.12.023. |
| 15108996 | Background | Myles PS. The pain visual analog scale: linear or nonlinear? Anesthesiology. 2004 Mar;100(3):744; author reply 745. doi: 10.1097/00000542-200403000-00042. No abstract available. |
| 36169068 | Background | Yahaya Y, Ismail AH, Shamsuddin NH. Primary dysmenorrhoea among reproductive-age women at Kuala Selangor health clinic: Prevalence and factors associated. Med J Malaysia. 2022 Sep;77(5):569-575. |
| 34360122 | Background | Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832. |
| 32415471 | Background | Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15. |
| 20044494 | Background | Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. doi: 10.1177/0363546509354163. Epub 2009 Dec 31. |
| 20638823 | Background | Lehman LA, Velozo CA. Ability to detect change in patient function: responsiveness designs and methods of calculation. J Hand Ther. 2010 Oct-Dec;23(4):361-70; quiz 371. doi: 10.1016/j.jht.2010.05.003. Epub 2010 Jul 17. |
| D010335 | Pathologic Processes |
| D017699 | Pelvic Pain |