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This study will be conducted as a randomized controlled quasi-experimental study to determine the effect of hot massage menstrual belt and stress relief ball application on pain intensity in women with dysmenorrhea. The study will include 105 women with dysmenorrhea (midwife, nurse, doctor, cleaning staff, secretary) who meet the inclusion criteria. Female participants between the ages of 18-45 will be randomly divided into three groups as experimental group 1 (n=35), experimental group 2 (n=35) and control group (n=35) by envelope method. Data will be collected using Informed Consent Form, Descriptive Information Form, Visual Pain Scale (VAS), Dysmenorrhea Impact Scale-Revised Short Form (DIS-R) and Menstrual Symptoms Scale. Descriptive Information Form, Visual Pain Scale (VAS), Dysmenorrhea Impact Scale-Revised Short Form (DIS-R) and Menstrual Symptom Scale will be applied to the three groups before the application. During the application, experimental group 1 will be given a menstrual belt with electric waist heating and vibration for 20 minutes. Experimental group 2 will be given a stress-relieving squeezing ball to feel its soft structure for the same period of time.The third group was determined as the control group and no application will be made. After the application, the participants will be asked to rate their pain intensity using the Visual Pain Scale (VAS) and record their pain scores.
Menstruation is a physiological condition that significantly affects women's lives and is a process that recurs every month and is defined as bleeding that is expelled by periodic shedding of the endometrium layer in fertile females. The process of menstruation, which affects the lives of women of reproductive age, causes periodic monthly changes in the uterus and ovaries. These changes occur under the influence of hormones such as luteinizing hormone (LH), estrogen, follicle-stimulating hormone (FSH) and progesterone. The menstrual cycle is responsible for ovum production and prepares the uterus for pregnancy. The average length of the cycle is 28 days (ranging from 21-35 days), and the cycle is recognized as one that begins in a woman's life at menarche and continues until menopause.Pain during menstruation is characterized by painful cramps usually on the first or second day of menstruation and is defined as dysmenorrhea. It is usually categorized into two types: primary and secondary. Primary dysmenorrhea is recurrent, cramping abdominal pain that occurs during menstruation without any identifiable pelvic pathology.Secondary dysmenorrhea occurs due to pelvic or uterine pathology (such as fibroids, endometriosis, infection, uterine and ovarian cysts and tumors).Secondary dysmenorrhea can begin at any time after menarche, but it can also present as a new symptom when a woman is in her 30s and 40s after the onset of the underlying condition.
The pain in dysmenorrhea usually starts in the first 1-2 years after menarche. The incidence of dysmenorrhea may vary because most women with this problem do not apply to any health institution. When we look at the researches, it has been found that approximately 25-90% of women in the reproductive period complain of dysmenorrhea. In dysmenorrhea, cramp-like pain, which is predominant in the suprapubic region, can sometimes be accompanied by various systemic symptoms such as nausea, vomiting, fatigue, irritability, changes in appetite, insomnia, diarrhea and headache.These symptoms can be experienced in different severities and can lead to significant medical and psychosocial problems.Dysmenorrhea reduces the quality of life of women by causing changes in their physical activities and social roles. By affecting daily activity and performance, it causes loss of working days, especially in working women, and absenteeism in women who are studying.Methods that can be used to prevent or reduce dysmenorrhea complaints; Hot treatment, Exercise, Transcutaneous electrical nerve stimulation (TENS), Vitamins, Acupuncture, distraction, menstrual belt can be recommended. In order to ensure effective coping with symptoms during menstruation, women should be educated, informed and behavior change should be ensured rather than drug treatment.
In our study, as a result of the literature review, there was no study on the hot massage electric waist-heated menstrual belt and stress ball squeezing, which are among the methods that can be used to prevent or reduce complaints in women with dysmenorrhea complaints. This study was planned to determine the effect of distraction with menstrual belt and stress relieving ball on women's pain intensity level during the menstrual cycle.
Methods:
In this study; It will be carried out as a randomized controlled quasi-experimental study to determine the effect of menstrual belt and stress relief ball application on pain intensity in women aged 18-45 years with dysmenorrhea.
Menstruation Symptom Scale permission to use the scale will be obtained by e-mail. In the Turkish validity and reliability article of Dysmenorrhea Impact Scale-Revised Short Form permission will be obtained for the measurement tool with the condition of citing the source. Ethics committee approval will be obtained by applying to Istanbul Gedik University Ethics Committee. After the ethics committee approval is obtained, a study permit will be obtained from the Istanbul Provincial Directorate of Health to conduct the research in Sultanbeyli State Hospital.
The data obtained in the study were analyzed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, mean and standard deviation were used as descriptive statistical methods in the evaluation of the data. Differences between the rates of categorical variables in independent groups were analyzed with Chi-Square tests.
Kurtosis and Skewness values were analyzed to determine whether the research variables were normally distributed. According to the relevant literature, kurtosis and skewness values between +1.5 and -1.5 (Tabachnick & Fidell, 2013) or +2.0 and -2.0 (George & Mallery, 2010) are accepted as an indicator of normal distribution. According to the results of the analysis, the kurtosis value for the total dysmenorrhea impact score was 0.605 and the skewness value was 0.589; the kurtosis value for the cognitive/emotional sub-dimension was 0.301 and the skewness value was 0.548; the kurtosis value for the physiological sub-dimension was 1.223 and the skewness value was 0.849. The kurtosis value for the total menstruation symptom score was 0.093 and the skewness value was 0.303; the kurtosis value for the negative effects sub-dimension was 0.128 and the skewness value was 0.281; the kurtosis value for the menstrual pain sub-dimension was 0.094 and the skewness value was 0.688; the kurtosis value for the coping methods sub-dimension was 1.047 and the skewness value was 0.049. These values indicate that all variables fit the normal distribution.In the analysis of the data, parametric.
Procedures:
The women who agreed to participate in the study and who met the sampling criteria were given verbal and written information about the study. The women who agreed to participate in the study were firstly informed about the purpose of the study, that permission was obtained from the hospital management and ethics committee to conduct the study, that their identity information was required for research consent, and that their identity information would be kept confidential by the researcher. A whatsapp group was established in order to learn more easily that women with dysmenorrhea working in the hospital had pain during menstruation and to reach them. After verbal and written consent was obtained from the women, it was determined which group they would be in by randomization. For randomization (35 people experiment 1, 35 people experiment 2, 35 people control group), the groups were determined by the envelope selection method in which the groups were written on the papers and the participants were distributed to experiment 1, experiment 2 or control group according to the paper they drew. In the application phase of the study, out of a total of 5 people who did not meet the inclusion criteria among the answers to the questions given in the pre-application questionnaire, 1 person with a chronic illness, 1 person with a psychological disorder, and 3 people with a visual pain scale (VAS) score below 4 were excluded from the study.
Instruments:
In the pre-application phase, the feasibility of the data collection forms and the experimental design were evaluated. In order to allocate volunteers to the experimental and control groups and to avoid negative results related to the experiment, the pre-application phase of the research was conducted on 10 people before the start of the research, and these people were not included in the research.
As there was no negative situation in the pre-application phase, the implementation phase of the research was started.
After the pre-application phase, the implementation phase began. Women who agreed to participate in the study were given verbal and written information about the study to those who met the sampling criteria. The women who agreed to participate in the study were first informed about the purpose of the study, that permission to conduct the research had been obtained from the hospital management and the ethics committee, that their identity information was required for research consent, and that their identity information would be kept confidential by the researcher. A Whatsapp group was created to make it easier to know and reach out to women with dysmenorrhea working in the hospital. After obtaining verbal and written consent from the women, randomization was used to determine which group they would be in. For the randomization (35 people in Experiment 1, 35 people in Experiment 2, 35 people in the control group), the groups were determined by the envelope selection method in which the groups were written on the papers and the participants were distributed to Experiment 1, Experiment 2 or the control group according to the paper they drew. Application phase of the research
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menstrual belt group | Experimental | Before any procedure was performed, the women included in the Experiment 1 group were administered the Volunteer Information and Consent Form, Introductory Information Form, Visual Pain Scale, Dysmenorrhea Impact Scale-Revised Short Form (DIS-R), and Menstruation Symptom Scale when they complained of dysmenorrhea during menstruation. In participants with dysmenorrhea pain of 4 or more, the electric menstrual belt that applies hot massage was used to all participants in a way that it did not come into direct contact with the skin over the top of the clothes during the 20 minutes planned for women to relieve pain on the day of menstruation. After the application was over, the participant was asked to fill out the Visual Pain Scale (VAS) form again to evaluate the effect of the use of the menstrual belt on the dysmenorrhea complaint felt during menstruation. |
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| Stress Relief Ball group | Experimental | The women included in the Experimental 2 group were administered the Volunteer Information and Consent Form, Introductory Information Form, Visual Pain Scale, Dysmenorrhea Impact Scale-Revised Short Form (DERS-R), and Menstruation Symptom Scale when they complained of dysmenorrhea during menstruation before any procedure was performed. At this stage, dysmenorrhea complaint was given to the participant with a score of 4 and above. On the day of menstruation, when dysmenorrhea complaint started, the women were given the anti-stress soft ball toy to squeeze in their hands within the planned 20 minutes. After the application was over, the participant was asked to fill out the Visual Pain Scale (VAS) form again to evaluate the effect of the use of anti-stress soft ball on the dysmenorrhea complaint experienced during menstruation. |
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| Control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change in VAS voice performance score following the characteristics of the menstrual cycle of two women | Other | application of menstrual belt and stress ball to women in the research group |
| Measure | Description | Time Frame |
|---|---|---|
| change in the vas visual pain scale of the research group after using the menstrual belt | Women in the research group applied menstrual belt and stress ball | 20 minutes after applying the menstrual belt and stress ball |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melek ERDOĞDU | Gedik University School of Nursing İstanbul, Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gedik University | Istanbul | 34000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Güvenç, G., Seven, M., & Akyüz, A. (2014). Menstrüasyon Semptom Ölçeği'nin Türkçe'ye Uyarlanması. TAF Preventive Medicine Bulletin, 13(5). | ||
| Background | Gün Kakaşçı, Ç., & Coşkuner Potur, D. İ. L. E. K. (2022). Menstruation Impact Scale Development. Medical records-international medical journal (Online), 4(3). | ||
| Background | Güvey, H. (2019). Adölesanlarda primer dismenore ve tedavi tedavileri. Jinekoloji-Obstetrik ve Neonatoloji Tıp Dergisi, 16 (3), 160-166 | ||
| Background | Gün, Ç. (2014). Dismenore etkilenmişlik ölçeğinin geliştirilmesi (Doctoral dissertation, Doktora Tezi, İstanbul). | ||
| Background | Boztaş Elverişli, G. (2022). Primer dismenoreli kadınlarda farmakolojik ve non-farmakolojik tedavinin etkinliğinin karşılaştırılması. | ||
| Background | Yürekdeler Şahin, N. (2017). Yüksek frekanslı TENS ile konnektif doku manipulasyonunun primer dismenore üzerine etkilerinin karşılaştırılması. | ||
| Background | Şaşmaz, Y. (2022). Çevrimiçi yoga temelli egzersiz programının primer dismenoreli kadınlarda etkisinin araştırılması (Master's thesis, İstanbul Medipol Üniversitesi, Sağlık Bilimleri Enstitüsü). |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Women enrolled in the control group did not undergo any procedure, and before and after the procedure, the informed consent form, the introductory information form, the visual pain scale, the Dysmenorrhea Impact Scale-Revised Short Form (DIS-R), and the menstrual symptom scale were used. Women with a Dysmenorrhea Impact Score of 4 and above were monitored for 20 minutes without intervention by starting a stopwatch on the telephone. At the end of the 20-minute follow-up period given to the control group, the stopwatch on the phone was stopped. The control group was asked to fill out the Visual Pain Scale (VAS) form again to evaluate the dysmenorrhea complaint scores after the follow-up was over. After answering the questions in the data collection forms, the individual questions were answered. |
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| 24230963 | Background | Potur DC, Bilgin NC, Komurcu N. Prevalence of dysmenorrhea in university students in Turkey: effect on daily activities and evaluation of different pain management methods. Pain Manag Nurs. 2014 Dec;15(4):768-77. doi: 10.1016/j.pmn.2013.07.012. Epub 2013 Nov 11. |
| Background | Potur, D. C. (2009). Lokal düşük Doz ısı uygulamasının Dismenore üzerine Etkileri (Doctoral dissertation, Marmara Universitesi (Turkey)). |