- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04356131
Effect of Massage and Progressive Relaxation Exercises on Primary Dysmenorrhea
The Effect of Massage and Progressive Relaxation Exercises on Pain Intensity and Menstrual Symptoms of Students With Primary Dysmenorrhoea
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dysmenorrhea is one of the most frequent problems during menstruation and described as periodic and painful pelvis menstruation among women at reproductive age. It is classified as primary and secondary dysmenorrhea. Primary dysmenorrhea (PD) is defined as suprapubic pelvis pain with cramps that begin a couple hours before menstrual bleeding, after menstrual bleeding, or during the last 12-72 hours of menstruation and occur repeatedly without organic pathology. PD is associated with an increase in prostaglandin production in the endometrium, which causes pain by increasing uterine contractions in the suprapubic region. According to De Sanctis et al., PD prevalence varies between 16% and 93%. It is often seen with sweating, fatigue, gastrointestinal system signs (lack of appetite, nausea, vomiting, diarrhea), and central nervous system signs (dizziness, headache, syncope, and lack of concentration). These symptoms that occur just before or just after menstrual bleeding among women with normal pelvic anatomy may prevent them from attending school and work or joining social activities. Secondary dysmenorrhea is defined as menstrual pain caused by a pathology in the pelvis such as endometriosis. If a patient has pain for 3-6 months, a more comprehensive evaluation of chronic pelvic pain should be performed to evaluate the potential etiologies of secondary dysmenorrhea.
The international literature includes oral contraceptive, nonsteroidal anti-inflammatory, and sedative drugs for the treatment of primary dysmenorrhea. However, the fact that some of these drugs cause side effects such as indigestion, headache, drowsiness, and substance addiction causes individuals to remain indifferent to them. In Turkey, it is reported that women prefer their family members as the first source of information and therefore use individual methods (massage, herbal teas, hot application, lying down, sweet food consumption, etc.) rather than pharmacological treatments due to cultural differences in coping with PD. Complementary and integrated therapy approaches, which are widely used all over the world today, have become common in coping with gynecological disorders among women in recent years. Some studies state that PD can be cured using such complementary therapies as essential oil acids, vitamins, acupuncture, herbal medicines, aromatherapy, reflexology, acupressure, massage, sports, and exercise. However, ACOG emphasizes that although these methods are frequently used by patients, they have not been studied enough yet, and mostly supports the use of exercise, high-frequency transcutaneous electrical nerve stimulation, and topical heat to help manage dysmenorrhea symptoms. Research on PD has applied massage and exercise practices using different application protocols. Studies on massage applications have examined the effect of inhaling herbal essential oils alone or together with massage. Research solely on exercise has examined the effectiveness of long-term and regular exercise, although with various practices. However, it can be said that massage and progressive relaxation exercises are more advantageous than other methods because they are easy, economical, and can be applied without the need for someone else.
Massage intensifies the blood flow in the area of application and reduces muscle tension. It also increases endorphin secretion and raises the pain threshold. Relaxation exercises, on the other hand, provide a decrease in sympathetic activity, an increase in parasympathetic activity and consequently a widening of the peripheral vessels, an increase in blood flow in the blood vessels, and a decrease in muscle tension and pain perception. Moreover, it has been reported that pain, anxiety, and depression symptoms decrease as a result of the decrease in the activation of the sympathetic nervous system, thanks to the deep breathing exercises performed during PRE. Therefore, it is predicted that massage combined with PRE will be beneficial in PD management. In this sense, this study was conducted to examine the effect of massage and PRE together on pain severity and other menstrual symptoms in PD treatment.
The literature includes no studies on the use of massage and PRE together in PD management. Therefore, the aim of the current study was to examine the effect of massage and PRE together on pain intensity and other menstrual symptoms in the management of PD.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mersin, Turkey
- Mersin University Faculty of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being older than 18 years,
- Having a dysmenorrhea pain intensity score ≥4 according to Visual Analog Scale (VAS),
- Having no previous pregnancy experience,
- Having no disease that leads to dysmenorrhea,
- Using no hormonal contraception or intrauterine device,
- Having a menstruation period of 3-8 days and a menstrual cycle of 21-35 days,
- Having no systemic-chronic disease or physical/mental health problems that prevent/restrict massage or exercise,
- Volunteering to participate in the study.
Exclusion Criteria:
- Being younger than 18 years
- Having a dysmenorrhea pain intensity score ≤ 4 according to Visual Analog Scale (VAS),
- Having previous pregnancy experience,
- Having disease that leads to dysmenorrhoea (endometriosis, ovarian cysts/tumors, pelvic infection disease, myoma/uterus tumor, uterus polyp, asherman syndrome, infection),
- Using hormonal contraception and intrauterine devices,
- Not to present a menstruation period that lasts 3-8 days and menstrual cycle of 21-35 days,
- Having a systemic and chronic disease (diabetes, heart diseases, vein diseases, circulatory disorders, varicosis, blood diseases, etc.),
- Having any physical/mental health problems that prevent/restrict massaging and exercising,
- Not to be voluntary to join the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: experimental group
Students in the experimental group were taught about massage and progressive relaxation exercises (PRE).
The phases of the massage and PRE trainings were first explained by being demonstrated by the author on herself.
In the meantime, the trainings were video-taped and uploaded to the mobile phones of the students.
After the author, each student was made to perform massage and PRE.
Both the exercises and massage techniques were daily performed 3 times a day after pain had started and relaxation exercises lasted 30 minutes whereas massage was performed for 15 minutes consecutively
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Progressive relaxation exercises included 30 minute rhythmic breathing and muscle relaxation exercises were demonstrated in the second part of the CD with river sounds and verbal instructions.
Massage techniques were performed on the site between upper symphysis pubis and umbilicus with 15 minute effleurage demonstrated in the third part of the CD with nature sound.
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No Intervention: control group
The students in the control group continued their routines during the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Students' individual and menstruation-related characteristics as assessed by "The Personal Information Form".
Time Frame: 1 day
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At the pretest stage of the research, by the experimental group and control group, "The Personal Information Form" form is filled in to specify individual characteristics and menstruation period characteristics.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Students' Menstruation Period Pain as assessed by The short-form McGill Pain Questionnaire.
Time Frame: 28 day
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By the experimental group in each menstrual period for 3 consecutive months: both the exercises and massage techniques were daily performed three times a day after pain had started and relaxation exercises lasted 30 minutes whereas massage was performed for 15 minutes and after that the form is filled in. Without any application by the control group the form is filled in after pain start. In the form, pain quality is determined with 15 descriptors that describe sensory (first 11) and affective pain (last 4). Dimension of pain is evaluated to demonstrate the intensity by using a rating of 0-3 (0=none, 1=mild, 2=moderate, 3=severe). Pain quality scores of sensory pain (0-33 score), of affective pain (0-12 score) and of total (0- 45 score) are obtained. A rise in total pain quality score indicates a rise in pain sensory. In the study in order to provide an overall intensity score; Visual analog scale is included in the scale. Visual analog scale suggests general pain intensity. |
28 day
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Students' Menstruation Period Menstrual Symptoms as assessed by Daily Symptom Rating Scale.
Time Frame: 28 day
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By the experimental group in each menstrual period for 3 consecutive months: both the exercises and massage techniques were daily performed three times a day after pain had started and relaxation exercises lasted 30 minutes whereas massage was performed for 15 minutes and after that "Daily Symptom Rating Scale" form is filled in. Without any application by the control group "Daily Symptom Rating Scale" form is filled in after menstrual symptoms start. In the scale that includes 17 symptoms, each symptom is scored according to its intensity with a five point rating between 0 and 5. An increase in scores indicates high intensity of the symptoms. |
28 day
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Avcı D.K, Sarı E. Approach to dysmenorrhea and effect of dysmenorrhea on social life and school performance in the university students. Van Medical Journal. 2018; 25(2): 188-193.
- Azima S, Bakhshayesh H.R, Mousavi S, Ashrafizaveh S. Comparison of the effects of reflexology and massage therapy on primary dysmenorrhea. Biomedical Research. 2015; 26 (3): 0976-1683.
- De Sanctis V, Soliman A, Bernasconi S, Bianchin L, Bona G, Bozzola M, Buzi F, De Sanctis C, Tonini G, Rigon F, Perissinotto E. Primary Dysmenorrhea in Adolescents: Prevalence, Impact and Recent Knowledge. Pediatr Endocrinol Rev. 2015 Dec;13(2):512-20.
- Memmott J. The effect of music-assisted progressive muscle relaxation on the self-reported symptoms of women with primary dysmenorrhoea [PhD thesis]. Kansas: University of Kansas; 2009.
- Apay SE, Arslan S, Akpinar RB, Celebioglu A. Effect of aromatherapy massage on dysmenorrhea in Turkish students. Pain Manag Nurs. 2012 Dec;13(4):236-40. doi: 10.1016/j.pmn.2010.04.002. Epub 2010 Sep 15.
- İbrahimoğlu Ö, Kanan N. The effect of progressive muscle relaxation exercises after endotracheal extubation on vital signs and anxiety level in open heart surgery patients. Turk Journal Intense Care. 2017; 15(3): 98-106.
- Mackereth PA, Booth K, Hillier VF, Caress AL. Reflexology and progressive muscle relaxation training for people with multiple sclerosis: a crossover trial. Complement Ther Clin Pract. 2009 Feb;15(1):14-21. doi: 10.1016/j.ctcp.2008.07.002. Epub 2008 Oct 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pain management
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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